Influence of Eat, Sleep, and Console on Infants Pharmacologically Treated for Opioid Withdrawal: A Post Hoc Subgroup Analysis of the ESC-NOW Randomized Clinical Trial

Author(s): Lori A. Devlin, Zhuopei Hu, Stephanie L. Merhar, et al.

Why was this study conducted?

This secondary analysis of infants enrolled in the Eating, Sleeping and Consoling for Neonatal Opioid Withdrawal (ESC-NOW) trial, which was conducted at 26 hospitals across the U.S., focused specifically on infants who received opioid treatment for NOWS after birth. The analysis was conducted to identify whether the ESC care approach decreased total postnatal opioid exposure when compared to sites’ usual care practices, which included the use of the Finnegan Neonatal Abstinence Scoring Tool (FNAST).

What was done?

The authors analyzed data from 463 infants who were enrolled in the ESC-NOW trial. All infants were born at 36 weeks’ gestation or later and received pharmacologic treatment for NOWS after birth. Three hundred and twenty infants were assessed and managed for NOWS with usual care, and 143 infants were assessed and managed with the ESC care approach.

What was found?

In this subgroup analysis, the authors found that total postnatal opioid exposure was substantially less for infants who were assessed and managed with the ESC care approach when compared to usual care.

The absolute mean difference in total opioid exposure was 4.1 morphine milligram equivalents (MME)/kilogram (kg) less for infants in the ESC group when compared to the usual care group (4.8 vs. 8.9 MME/kg respectively). Infants in the ESC group also received an average of 48.7 fewer opioid doses than those in the usual care group (67.5 vs. 116.1 doses respectively). In addition, the mean length of opioid treatment was 6.3 days less in the ESC group than in the usual care group (11.8 vs. 18.1 days respectively), and the mean length of hospital stay was 6.2 days less in the ESC group than in the usual care group.

The authors also found that the mean time from birth to the initiation of pharmacologic care was 22.4 hours longer in the ESC group than in the usual care group (75.4 vs. 53.0 hours respectively), but there was no difference in the mean peak opioid dose between groups.

What do the results mean?

Infants who were assessed and managed with the ESC care approach received less opioid medication for the treatment of NOWS after birth when compared to those who were assessed and managed with usual care, including the FNAST.
Infants assessed and managed with the ESC care approach also had fewer days of opioid treatment and a shorter length of hospital stay when compared to usual care.
The time from birth to the initiation of opioid treatment was longer in infants who were assessed and managed with the ESC care approach, but there was no difference in the peak dose of opioid medication, which suggests that the ESC care approach aptly assesses and supports acute opioid withdrawal.

Who sponsored this study?

This clinical trial is a collaboration between the NIH Environmental influences on Child Health Outcomes (ECHO) Program and the NIH’s Eunice Kennedy Shriver Institute of Child Health and Human Development (NICHD), funded through the NIH Helping to End Addiction Long-term® Initiative (HEAL).

Where can I learn more?

Access the full journal article, titled “Influence of Eat, Sleep, and Console on Infants Pharmacologically Treated for Opioid Withdrawal: A Post Hoc Subgroup Analysis of the ESC-NOW Randomized Clinical Trial,” in JAMA Pediatrics.

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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Influence of Eat, Sleep, and Console on Infants Pharmacologically Treated for Opioid Withdrawal: A Post Hoc Subgroup Analysis of the ESC-NOW Randomized Clinical Trial

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Phenobarbital and Clonidine as Secondary Medications for Neonatal Opioid Withdrawal Syndrome

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Site-Level Variation in the Characteristics and Care of Infants with Neonatal Opioid Withdrawal

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Can People Living in Rural Areas Accurately Measure Their Height and Weight at Home?

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Can People Living in Rural Areas Accurately Measure Their Height and Weight at Home?

Study title: Validation of remote height and weight assessment in a rural randomized pediatric clinical trial in primary care settings

Author(s): E (Alice) Zhang, Ann M. Davis, Elizabeth Yakes Jimenez, Brittany Lancaster, Monica Serrano-Gonzalez, Di Chang, Jeannette Lee, Jin-Shei Lai, Lee Pyles, Timothy VanWagoner, Paul Darden

Why was this study conducted?

Children living in rural areas have a greater risk for overweight. It may also be hard for them to join weight management programs or studies that require in-person visits. This study compared the accuracy of at-home height and weight measurements to those taken in person at a clinic.

What was done?

A total of 33 parent/child pairs took part in the study; the children were 6-11 years old. We gave each pair a digital bathroom scale, a tape measure, and instructions on measuring height and weight. Then, we guided them as they took their in-home measurements through a video call. The pairs also came to the clinic for their in-person measurements. Then, we compared the at-home and in-person measurements.

What was found?

There were no significant differences in the overall height and weight measurements taken at home compared to those taken in person at the clinic. However, some individual heights and weights differed significantly between at-home and in-person measurements. Age, race, ethnicity, parent education level, household income, and zip code were not significant predictors of at-home and in-person measurement comparisons.

What do the results mean?

It is possible to use everyday tools and technology to measure the weight and height of children living in rural areas. However, using these tools might reduce the accuracy of the measurements. Researchers and clinicians need to decide how accurate they need measurements to be before using these tools in the home.

Who sponsored the study?

This research was supported by the Environmental Influences on Child Health Outcomes (ECHO) program, the office of the Director, National Institutes of Health.

Appreciation

The researchers thank the wonderful families who made this work possible. We also thank Drs. Rebecca Romine and Kandace Fleming from the Life Span Institute, University of Kansas, for their input on data interpretation.

You may learn more about this publication here: https://www.nature.com/articles/s41598-023-50790-1

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Published: January 3, 2024

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Can People Living in Rural Areas Accurately Measure Their Height and Weight at Home?

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General health and life satisfaction in children with chronic illness

Author(s): Courtney K. Blackwell, et al

ECHO Study Suggests Neighborhood Conditions Throughout Childhood May Shape Risk of Developing Asthma

Authors: Izzuddin Aris, et al.

ECHO Cohort Study Identifies Best Tests of Biological Age to Use for Different Types of Pediatric Tissue Samples

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ECHO Cohort Study Identifies Best Tests of Biological Age to Use for Different Types of Pediatric Tissue Samples

Authors: Fang Fang, et al.

Who sponsored this study?

The Environmental influences on Child Health Outcomes (ECHO) Program, Office of The Director, National Institutes of Health supported this research.

Why was the study needed?

A molecular process called DNA methylation, or DNAm, that adds a tag to the DNA that can control gene expression. Certain well-studied DNAm have been associated with many age-related chronic diseases, including aging itself.

Researchers have developed biochemical models called epigenetic clocks that use DNAm to estimate an individual’s biological age. Scientists have studied these clocks in adult populations in whom accelerated biological age (DNAm-predicted age older than actual chronological age) seems strongly connected to age-related health complications. However, only epigenetic clocks for pediatric populations have only recently been built. Epigenetic clocks also allow scientists to evaluate the impact of various environmental exposures on early-life development and children’s health outcomes.

This study conducted a comprehensive evaluation on seven of these epigenetic clocks—Horvath, Knight, Bohlin, Lee, Mayne, PedBE, and NeoAge—all of which researchers developed for different purposes and tissue types. It is important for scientists to understand how these clocks perform in different tissue types and developmental stages throughout early life to ensure researchers are designing studies appropriately and then correctly interpreting the results of these studies.

What were the study results?

The results of this study suggest that the best epigenetic clock to use depends on the type of sample being studied. For example, the Bohlin and Knight clocks were very similar when predicting gestational age from blood cell samples; the Lee clock outperformed the Mayne clock in predicting gestational age from placental samples; and the PedBE clock was more accurate than the Horvath clock at predicting chronological age from buccal cells. However, the Horvath clock was better at predicting chronological age when using blood cells samples. The study results suggest the importance of researchers choosing the appropriate clock depending on the focus of their study.

Footnote: Results reported here are for a single study. Other or future studies may provide new information or different results. You should not make changes to your health without first consulting your healthcare professional.

What was the study's impact?

This study provides practical recommendations for selecting the most appropriate epigenetic clock in different research contexts, therefore leading to more accurate estimates of biological age. The findings of this study may help scientists make better research tools, improving child health research.

Who was involved?

Researchers used data from 3,789 children, who contributed a total of 4,555 samples, from 20 ECHO research sites. The sample set consisted of 2,273 male and 2,282 female samples.

What happened during the study?

The researchers evaluated seven different epigenetic clocks based on the DNAm data generated from the selected sample set. The study evaluated each clock in corresponding tissues based on previous study results, and then compared clocks across different tissue samples. After comparing the suitability of various epigenetic clocks for each tissue type, researchers evaluated their performance across diverse populations. This evaluation included comparing epigenetic clocks between preterm and term infants within the same tissue type, across different self-reported racial groups, between males and females, and across different tissue types within the same set of participants.

What happens next?

Future studies may use the various epigenetic clocks as recommended to check the health of babies and children. However, researchers should interpret this data with caution as it pertains to conclusions about the performance of specific epigenetic clocks in pediatric populations with varied health backgrounds. Future studies may examine the effects of genetics on the performance of different epigenetic clocks.

Where can I learn more?

Access the full journal article, titled “Evaluation of Pediatric Epigenetic Clocks Across Multiple Tissues,” in Clinical Epigenetics.

The content is the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Published October 9, 2023

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ECHO Cohort Study Identifies Best Tests of Biological Age to Use for Different Types of Pediatric Tissue Samples

Shortened Social Responsiveness Scale (SRS) Observed to be Comparable to Full SRS in Autism Risk Factor Estimation

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Shortened Social Responsiveness Scale (SRS) Observed to be Comparable to Full SRS in Autism Risk Factor Estimation

Authors: Marisa Patti, Kristen Lyall, et al.

Who sponsored this study?

The Environmental influences on Child Health Outcomes (ECHO) Program, Office of the Director, National Institutes of Health supported this research.

Why was this study needed?

The Social Responsiveness Scale (SRS) is a questionnaire used to measure social communication and autism spectrum disorder (ASD)-related traits. Researchers have developed a shortened version of the SRS, which included only 16 questions out of the original 65. This shortened version is intended to provide a very similar summary of behaviors and traits as the longer version but takes less time to complete.

As a new tool, the short SRS has been previously tested to ensure that it measures autism spectrum-related traits. However, it was not clear prior to this study if the short SRS can measure associations in epidemiologic analyses of autism spectrum risk factors in the same way as the full SRS so that research findings can be comparable across studies using both versions. In other words, do scores from both the short and long versions suggest the same associations? Or does shortening the SRS reduce our ability to detect risk factors due to differences in measurement? In this study, the authors tested associations with an established risk factor for autism diagnosis, preterm birth, or gestational age, to see if patterns were consistent across versions.

What were the study results?

Younger gestational age and preterm birth were associated with higher full SRS scores. The same associations were seen with short SRS scores. These associations are also consistent with associations seen for autism diagnosis, suggesting the ability of both the full and short SRS to detect risk factor associations.

Footnote: Results reported here are for a single study. Other or future studies may provide new information or different results. You should not make changes to your health without first consulting your healthcare professional.

What was the study's impact?

Gathering meaningful information for research studies can be a lengthy and time-consuming process for participants. This study shows that in some studies information collected using shorter assessments can be as useful as that captured using longer assessments, helping to reduce the time participants spend answering questionnaires.

Who was involved?

The study included 2,760 child-parent pairs from 11 different research sites within the ECHO Program. Participating children were between 2.5 and 18 years in age. The study sample included participants from research sites drawn from the general population, pre-term birth research sites, and familial-autism research sites, the last consisting of participants with a child diagnosed with autism.

What happened during the study?

Researchers collected caregiver-reported responses from both the full and shortened SRS. Information on gestational age and pre-term birth were collected from maternal reports on standardized questionnaires and from medical records.

What happens next?

Future studies are needed to investigate how comparable estimates are between the full and short SRS using other types of risk factors, such as genetic factors, and in other study populations. Researchers may also consider using the short SRS in future studies as an efficient measure of social behaviors.

Where can I learn more?

Access the full journal article, titled “A Comparative Analysis of the Full and Short Versions of the Social Responsiveness Scale in Estimating an Established Autism Risk Factor Association in ECHO: Do we Get the Same Estimates?” in the Journal of Autism and Developmental Disorders.

The content is the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Published July 22, 2023

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Shortened Social Responsiveness Scale (SRS) Observed to be Comparable to Full SRS in Autism Risk Factor Estimation

Shorter Questionnaire Shown Effective for Measuring Autism-Related Traits in Children

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Shorter Questionnaire Shown Effective for Measuring Autism-Related Traits in Children

Authors: Aaron Kaat, Kristen Lyall, et al.

Who sponsored this study?

The Environmental influences on Child Health Outcomes (ECHO) Program, Office of the Director, National Institutes of Health supported this research.

Why was this study needed?

Prior research has developed and examined shortened versions of the SRS questionnaire, but this has been mostly done with school-age participants with autism and their family members. Researchers haven’t been able to evaluate the reliability of shortened versions of the SRS for capturing broader traits in the general population or for preschool-age participants. In addition, prior studies have not developed a shortened version of the questionnaire that uses computer-adaptive testing to select relevant questions based on a participants existing answers.

What were the study results?

The Social Responsiveness Scale (SRS) is frequently used to measure autism-related traits and social impairments. The full 65-question SRS can create more burden for participants, so many researchers have attempted to shorten the questionnaire. In this study, ECHO researchers evaluated the SRS questionnaire across two different versions for preschool and school-age groups, comparing the questions used on each and developing a comparable scoring method for both forms. They then used computer-adaptive testing, where a computer program tailors the questionnaire in real-time to each participant, and found that a median of 14 questions was sufficient to reach a reliable score.

What was the study's impact?

The results of this work suggest opportunities to reduce the amount of time participants spend completing questionnaires like the SRS without sacrificing accuracy. Additionally, the results suggest computer-adaptive questionnaires can be used to evaluate autism-related traits in a way that is comparable to standard fixed questionnaires, improving testing efficiency and reducing participant burden.

Who was involved?

This study included 7,030 children from multiple ECHO research sites and other large studies across the United States. Participants included children ranging from ages 2.5-18 years, most of whom did not have an autism diagnosis.

What happened during the study?

The researchers collected data on the preschool and school-age SRS forms from multiple different sources. They then conducted several analyses to assess a variety of factors that may affect how the full SRS and shortened versions of the SRS are scored. The researchers then used these data to simulate how computer-adaptive testing would score each individual after completing the minimum number of questions required to reach a comparable result.

Footnote: Results reported here are for a single study. Other or future studies may provide new information or different results. You should not make changes to your health without first consulting your healthcare professional.

What happens next?

The researchers’ follow-up analyses to this work compared the computerized version developed in this study to other versions of the questionnaire. Future research is needed to examine how these different questionnaires perform in different groups of people, and if results differ when captured according to self vs parent report.

Where can I learn more?

Access the full journal article, titled “Modifying the Social Responsiveness Scale for Adaptive Administration,” in Quality of Life Research.

The content is the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Published March 21, 2023

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Shorter Questionnaire Shown Effective for Measuring Autism-Related Traits in Children

ECHO Researchers Demonstrate Reliability of Room-Temperature, Methanol-Preserved Placental Samples for Measuring Metabolism

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ECHO Researchers Demonstrate Reliability of Room-Temperature, Methanol-Preserved Placental Samples for Measuring Metabolism

Authors: Jennifer Straughen, et al.

Who sponsored this study?

This research was supported by the Environmental influences on Child Health Outcomes (ECHO) program, Office of The Director, National Institutes of Health.

What were the study results?

The results show that metabolic data with similar quality can be obtained from placental tissue samples preserved in methanol at room temperature than from flash-frozen samples—though a greater number of metabolites were typically detected in the methanol-fixed samples and the methanol extract.

Footnote: Results reported here are for a single study. Other or future studies may provide new information or different results. You should not make changes to your health without first consulting your healthcare professional.

What was the study's impact?

The results of this study show that placental tissue preservation in methanol at room temperature may be a suitable alternative method for analysis of placental metabolism. This method is more feasible and cost-effective than flash freezing, especially in community-based hospitals. As such, this study may make it easier for researchers to study the function of placentas and their potential relation to health outcomes.

Why was the study needed?

The placenta is an organ that provides nourishment to a developing fetus before it is born. Understanding metabolism within the placenta—the production and breakdown of molecules that provides energy to the placenta—might help researchers learn more about its function during pregnancy. To date, methods to collect placental samples to measure metabolism are expensive and require specialized equipment. In this study, researchers compared data from placental samples collected at room temperature to samples collected by flash-freezing, the standard method.

Who was involved?

The researchers collected placental samples from mothers within 15 minutes after delivery of the placenta at Henry Ford Health in Detroit, Michigan. All samples were anonymous.

What happened during the study?

The researchers collected pea-sized pieces of placenta tissue using the flash-freezing method and the test method (fixed in a solution of methanol at room temperature) and compared the resulting metabolism data.

What happens next?

More work is needed to describe the placental metabolic data revealed during this study and compare it to data from previous studies. Researchers will also need to repeat this study with a larger number of placentas to confirm the findings.

Where can I learn more?

Access the full journal article titled “Comparison of methanol fixation versus cryopreservation of the placenta for metabolomics analysis” published in Scientific Reports.

The content is the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Published March 11, 2023

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ECHO Researchers Demonstrate Reliability of Room-Temperature, Methanol-Preserved Placental Samples for Measuring Metabolism

ECHO Study Compares Cross-Cultural Patterns of Attention Linked to Underlying Behavior Problems in Children

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ECHO Study Compares Cross-Cultural Patterns of Attention Linked to Underlying Behavior Problems in Children

Authors: Sara Nozadi, Andréa Aguiar, et al.

Who sponsored this study?

This research was supported by the Environmental influences on Child Health Outcomes (ECHO) program, Office of The Director, National Institutes of Health.

What were the study results?

Patterns of attention were similar across the two groups of children despite the differences in their cultures, demographics, or assessment settings. Overall, children paid more attention to emotional faces compared to neutral faces. They were particularly quick to identify angry faces, which might be an adaptive response to a perceived threat. These findings replicate previous research results with both adults and children.

Indigenous children with socially withdrawn behaviors avoided emotional faces—a response observed in children with higher levels of socially withdrawn behaviors from other populations.

Footnote: Results reported here are for a single study. Other or future studies may provide new information or different results. You should not make changes to your health without first consulting your healthcare professional.

What was the study's impact?

This work suggests that eye tracking can be used as an objective measure of attention patterns in children across different settings and cultures, which can help researchers and clinicians more reliably identify children with early behavior problems. Because eye tracking technology does not rely on clinical observations or parents’ reports, it can be used as an unbiased measure across different communities to validate data collected through clinical assessments and parent reports in hard-to-reach communities.

Why was this study needed?

Humans tend to give more attention to emotional information than neutral information. Past research indicates departures from this pattern typically occur in children with socially withdrawn behaviors. However, this research is limited because it has been conducted mostly in controlled settings among primarily White children from urban areas.

In this study, ECHO researchers examined the extent to which two eye-tracking–based measures could be used cross-culturally to assess attention biases and how these biases might relate to children’s socially withdrawn behaviors.

Who was involved?

To evaluate whether eye-tracking technology could be applied effectively across cultures, researchers compared information from two ECHO cohorts that were very different demographically, geographically, racially, and culturally.

The researchers analyzed data from 125 children from the Navajo Birth Cohort Study, a cohort of indigenous children with relatively low socioeconomic status (SES) living in rural tribal lands, and 70 children from the Illinois Kids Development Study (IKIDS), a primarily Non-Hispanic White and high-SES cohort living around the University of Illinois at Urbana-Champaign campus in central Illinois.

What happened during the study?

Children between the ages of 3.5 years to 5.5 years completed two eye-tracking tasks that measured their attention to photos of human faces with positive, negative, and neutral expressions. Indigenous children were assessed in different locations in the Navajo territory, whereas IKIDS children came to a research laboratory in the University campus. Mothers also reported on children’s socially withdrawn behaviors, such as avoiding eye contact, using the Child Behavioral Checklist—a survey commonly used in research and clinical settings to evaluate risk for behavioral and emotional problems in children.

What happens next?

The researchers will look at how the responses they see in these young children change with age and determine whether eye tracking continues to be an unbiased tool for assessing attention throughout development.

Where can I learn more?

Access the full journal article titled “Cross-Cultural Applicability of Eye-Tracking in Assessing Attention to Emotional Faces in Preschool-Aged Children” published in the Emotion Journal.

The content is the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Published: September 15, 2022

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ECHO Study Compares Cross-Cultural Patterns of Attention Linked to Underlying Behavior Problems in Children

Conducting a Pediatric Randomized Clinical Trial During a Pandemic: A Shift to Virtual Procedures

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Conducting a Pediatric Randomized Clinical Trial During a Pandemic: A Shift to Virtual Procedures

Authors: James Roberts, Sheva Chervinskiy, Russell McCulloh, Jessica Snowden, Paul Darden, Thao-Ly Phan, Erin Dawley, Victoria Reynolds, Crystal Lim, Lee Pyles, DeAnn Hubberd, Jaime Baldner, Lora Lawrence, Ann Davis

Who sponsored this study?

This research was supported by the Environmental influences on Child Health Outcomes (ECHO) program, the Office of the Director, National Institutes of Health.

What was done?

The study's goal was to enroll 128 children aged 6 to 12 years old and one parent at four rural clinics over 10 weeks. However, the trial was paused after 6 weeks due to COVID-19. Over the next 12 weeks, the trial resumed using virtual visits where investigators completed enrollment, obtained informed consent, and assessed height and weight of children. Because all study activity was virtual, digital scales and height measurement equipment were shipped to participants' homes, and a second virtual visit was conducted to monitor these measurements. Some participants who did not have internet and needed support for virtual visits received internet-enabled tablets.

What was found?

When the trial was paused, 42 patients had been enrolled. When the trial resumed virtually, 28 of the 42 continued in the trial, and an additional 89 new participants were enrolled for a total of 117 children. Flexibility was key to solving problems and continuing to enroll and retain participants.

The investigators discovered the challenges and benefits of conducting a virtual trial of this nature. Some challenges to conducting a virtual trial include unreliable equipment delivery, unreturned study equipment, slow Internet speeds and/or poor Internet access in rural areas, and the added costs of buying and shipping equipment and mailing other study materials. However, the benefits of a virtual trial included the ability to conduct study visits at other times of the day, including evenings and weekends. For example, research staff could conduct study visits at any time of the day, and study-related travel was limited.

What do the results mean?

The lessons learned from this trial can be applied by any study team recruiting participants from rural areas for a clinical trial. These include:

Virtual visits and procedures enable successful recruitment and retention of participants from rural areas.
Research teams must be agile, flexible, and willing to adapt study procedures to meet clinic resources and unanticipated situations.
While there are considerable additional expenses for buying and shipping study equipment to participants, these costs may be offset by decreased travel to and from rural areas by study staff.

Why was this study conducted?

In the United States, children living in rural areas have higher rates of being overweight. Unfortunately, children from rural areas seldom participate in clinical research trials. A clinical research trial on changing lifestyle behaviors in rural children who were overweight started in early 2020 but, due to the COVID-19 pandemic, had to switch to virtual procedures instead of in-person visits. Sharing the solutions to problems faced and the lessons learned in completing this trial may help other research teams recruit participants living in rural areas.

Appreciation:

The authors appreciate the children, families, and clinics whose participation made the research possible.

You can read the full publication here: https://doi.org/10.1017/cts.2022.453

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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Conducting a Pediatric Randomized Clinical Trial During a Pandemic: A Shift to Virtual Procedures

Facilitators and Barriers to Pediatric Clinical Trial Recruitment and Retention in Rural and Community Settings: A Scoping Review of the Literature

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Facilitators and Barriers to Pediatric Clinical Trial Recruitment and Retention in Rural and Community Settings: A Scoping Review of the Literature

Author(s): Sara E. Watson, Paul Smith, Jessica Snowden, Vida Vaughn, Lesley Cottrell, Christi A. Madden, Alberta S. Kong, Russell McCulloh, Crystal Stack Lim, Megan Bledsoe, Karen Kowal, Mary McNally, Lisa Knight, Kelly Cowan, Elizabeth Yakes Jimenez

Who sponsored this study?

This research was supported by the Environmental influences on Child Health Outcomes (ECHO) program, Office of The Director, National Institutes of Health.

What was done?

The authors conducted a review of published research papers to determine what factors make it easier or harder for children to participate in clinical research studies in rural and community-based settings. The authors considered studies to have been conducted in a “community-based setting” if all activities occurred outside of a clinic or hospital. The team reviewed other published articles to determine what strategies other researchers had used to enroll children in studies and help them stay enrolled until the studies were completed. They then looked to see which strategies were most helpful.

What was found?

In this systematic review, there were few published studies that specifically describe useful strategies for enrolling children in rural settings into clinical trials or strategies to help them stay enrolled. Strategies that have been helpful include sending families visit reminders, building relationships with community members, making it easier for families to get to study visits, and paying families for the time they spend participating in the study. Not having enough staff and resources were listed as barriers to enrolling children and helping them stay enrolled in studies.

What do the results mean?

More studies are needed to understand the best ways to engage children and their families in rural areas in clinical trials. While many of the factors identified in this review that are barriers to or supporting of research are common across all research—such as participant reminders, building relationships with families, and adequate resources—it is critical that study teams look specifically at issues important to rural communities—such as paying for travel costs and facilitating delivery of study materials to remote sites.

Why was this study conducted?

Good clinical trials can help improve patient health outcomes by informing evidence-based medicine and public health interventions. However, children and adults who live in rural settings are underrepresented in clinical trials. This can affect the quality of health care for rural populations and contribute to rural health disparities.

You may learn more about this publication here: https://ascpt.onlinelibrary.wiley.com/doi/10.1111/cts.13220

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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Facilitators and Barriers to Pediatric Clinical Trial Recruitment and Retention in Rural and Community Settings: A Scoping Review of the Literature

ECHO Researchers Develop Shorter Survey for Measuring Sources of Stress in Adults

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ECHO Researchers Develop Shorter Survey for Measuring Sources of Stress in Adults

Author(s): Phillip Sherlock, Madeleine U. Shalowitz, Carolyn Berry, David Cella, Courtney K. Blackwell, Whitney Cowell, Karen M. Reyes Rodriguez, Rosalind J. Wright

Who sponsored this study?

This research was supported by the Environmental influences on Child Health Outcomes (ECHO) program, the Office of the Director, and the National Institutes of Health.

What were the study results?

The researchers were able to reduce the 80-question CRISYS-R to just 24 essential questions, resulting in a short form CRISYS questionnaire (CRISYS-SF). The CRISYS-SF covers the same 11 areas of stress that are addressed in the CRISYS-R. Participants received very similar scores from both the CRISYS-R and CRISYS-SF.

Footnote: Results reported here are for a single study. Other or future studies may provide new information or different results. You should not make changes to your health without first consulting your healthcare professional.

What was the study's impact?

In large-scale studies, lengthy questionnaires can contribute to lower response rates, leading to incomplete or low-quality data. The CRISYS-SF offers doctors and researchers a way to screen for participant stress, identifying the sources of that stress, and determining the most effective interventions.

Why was this study needed?

Stress can have a significant impact on the psychological, social, and physical health of individuals. But the questionnaires that are often used to understand stress exposure can be long and burdensome. The goal of this research was to create a shorter version of the Crisis in Family Systems-Revised (CRISYS-R) that still covers all relevant areas of stress.

Who was involved?

The study included 884 pregnant women from the PRogramming of Intergenerational Stress Mechanisms (PRISM) study, which recruited pregnant women from prenatal clinics in New York City and Boston beginning in 2011. One-third of these women were born outside of the U.S., and 20% spoke Spanish as a primary language. Around 20% of participating women had less than a high school education, and 60% reported having financial trouble.

What happened during the study?

Participants completed the CRISYS-R questionnaire through an in-person or phone interview in their preferred language. The researchers used statistical methods and expert feedback to identify which questions on the CRISYS-R provided the most insight into the participant’s level of stress exposure.

What happens next?

Researchers can use the CRISYS-SF to investigate relationships between stressful life events and specific health outcomes.

Where can I learn more?

Access the full journal article, titled “A short form of the Crisis in Family Systems (CRISYS) in a racially diverse sample of pregnant women,” published in Current Psychology.

The content is the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Published 01 October 2021

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ECHO Researchers Develop Shorter Survey for Measuring Sources of Stress in Adults