Family Resilience Initiative Research Program
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|ClinicalTrials.gov Identifier: NCT04018404|
Recruitment Status : Not yet recruiting
First Posted : July 12, 2019
Last Update Posted : July 17, 2019
|First Submitted Date ICMJE||July 10, 2019|
|First Posted Date ICMJE||July 12, 2019|
|Last Update Posted Date||July 17, 2019|
|Estimated Study Start Date ICMJE||July 15, 2019|
|Estimated Primary Completion Date||June 2022 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||Family Resilience Initiative Research Program|
|Official Title ICMJE||Family Resilience Initiative Research Program|
|Brief Summary||University Le Bonheur Pediatric Specialists (ULPS) and Le Bonheur Community Health and Well-Being, Maternal Child Department, have started the Family Resilience Initiative (FRI) in the ULPS General Pediatrics Clinic. This clinical program screens children 9 to 48 months of age for Adverse Childhood Experiences (ACEs) and Social Determinants of Health (SDH) at the time of presentation for well child checks. Children with positive screens for ACES and/or SDH, and their adult caregivers, receive community resource referrals with warm handoffs to vetted organizations. In addition, if indicated, psychological services are offered for children based upon the presence of one or more of ACEs and current health, social, and behavioral problems. It is expected that enrollment in FRI will improve quality of life for families through reduction in stress by addressing unmet social needs and providing psychological counseling of children and families with any ACE exposure. The investigators expect that FRI will have a positive impact on the physical health, healthcare utilization, mental health, development, and school readiness of children in the program compared to controls. The investigators will compare changes in weight for height and blood pressure percentiles at enrollment and end of study and the number of unscheduled healthcare visit for illness for children in the FRI clinical program compared to controls, receiving standard of care. Healthcare visits include visits to the clinic and visits to the Le Bonheur Emergency Department. The investigators will also compare pre- and post-treatment scores on the validated Child Behavior Checklist and Parenting Stress Index as a measure of stress reduction. Furthermore, the investigators will measure age appropriate attainment of developmental milestones scores on early, school-based testing (MAP) testing scores obtained through Seeding Success. The investigators will also determine rates of physician-diagnosed early behavioral disorders such as ADHD. The investigators expect that reduced stress and its downstream conditions will lead to decreased healthcare visits, improved attainment of developmental and educational milestones, and lower rates of behavioral disorders.|
Adverse childhood experiences (ACEs), social determinants of health (SDH) and their downstream health effects are the public health crisis of our time. Many chronic diseases are known to originate with, or are exacerbated by, exposure to toxic stress in childhood including learning and cognitive disabilities, asthma, obesity, diabetes, cancer, and behavioral health disorders such as ADHD, depression and substance abuse. While poverty is not considered an ACE, ACE exposure and unmet social needs are more common in those living in lower income communities. Memphis, the poorest statistical metropolitan area in the country with a population over one million people has an overall poverty rate of 26.9% and a child poverty rate of 44.7%. A telephone survey of over 1500 Shelby County residents conducted in the summer of 2014 found that 52% of adults reported at least one ACE and 12% reported four or more. Race is also an important factor in health disparities. Although the effects of race are predominantly due to associated income inequities, systemic racism can also have effects on health. For example, disparities in birth outcomes between black and white mothers exists across all socioeconomic strata but is most prominent among highly educated African American women.
The association between poverty and ill health is likely mediated through several pathways. In impoverished households there may be limited cognitive stimulation and neglect. Poor quality and location of housing may expose children to environmental toxins such as lead or air pollution and allergens. Poor diet may result in micronutrient deprivation. In addition to these known negative exposures, environmental stress through exposure to familial discord and disruption, intrafamily violence, overcrowding of the home, and neighborhood violence appears also to play a role in the poor mental and physical health of individuals with these exposures.
The link between toxic stress from ACES and other social determinants of health and adverse physical and mental health outcomes is derived from mostly cross-sectional studies where individuals with and without certain health conditions are compared for exposure to ACEs and SDH. These studies have been critical in revealing the spectrum of childhood and adult conditions that may be triggered or exacerbated by toxic stress. Both acute severe stress stemming from exposures like child maltreatment and chronic lower grade stresses stemming from exposure to poverty and its associated risks are associated with physical and mental illness. Much of the research into the mechanisms underpinning these associations has examined the epigenetic effect of these episodic or longer-term stressors. Epigenetics refers to post-translational modifications of DNA such as methylation, the covalent binding of methyl groups at CpG sites, oligodeoxynucleotides where cytosine is adjacent to guanine. Changes in methylation patterns can result from de novo methylation of DNA or removal of pre-existing methylation sites. Most epigenetic changes influence gene transcription through methylation of promotor and repressor regions. A gene promotor containing methylated CpG sequences is less able to bind transcription factors resulting in reduced gene transcription. Many studies have found differential methylation of areas within genes as well as intergenic areas of DNA. The effect these areas of methylation have on gene expression are unknown. Histones, proteins around which DNA is coiled, can be modified as well through methylation and acetylation. These modifications are thought to relax DNA coiling and open up gene regulatory sites for interaction with transcription factors.
There have been studies examining differences in methylation across the genome, comparing the number of sites with increased and reduced methylation and drawing inferences as to the effect of these differences on phenotype. Many such studies have demonstrated clear differences in methylation patterns between subjects with greater and lesser exposure to episodic and lifetime stress. Differential methylation of specific genes and their promotor regions have also been studied, specifically, genes that could be reasonably hypothesized to play a role in the response to stress and the mitigating effects of different levels of caregiving. These include the genes for the glucocorticoid receptor, serotonin and oxytocin. The effects of chronically or acutely elevated cortisol levels on the methylation of the glucocorticoid receptor gene and its promotor are, perhaps, the most extensively studied in relation to ACEs and SDH. Animal studies have demonstrated an effect of high levels of caregiving on levels of glucocorticoid receptor expression in key areas of the brain through epigenetic changes which can improve self-regulation and mitigate the effects of toxic stress. These epigenetic modifications have been demonstrated to be transmitted across generations and may account for cross generational protection or vulnerability to the effects of toxic stress.
Most human data on the effects of epigenetics are derived from retrospective and cross-sectional studies in which individuals with certain health conditions report on past or current exposure to ACEs and/or SDH. Many of these studies examine the cumulative risk of exposure over the lifetime of the study subject up to the point of the research. There does appear to be a dose response relationship between earlier stressors and adolescent and adult mental and physical health. Interventions applied early may, therefore, have the potential to mitigate the effects of toxic stress on health even if exposures have already occurred and prevent these important, long-term impacts on health and well-being. Mitigating factors include high family functioning with lower levels of parental stress and greater parent-child communication, as well as access to a medical home.
Primary care is the cornerstone for screening, health promotion and disease prevention and pediatricians are best situated to screen for and address ACEs and SDH. Studies have demonstrated that many physicians do not perform any formal screening for ACEs but that individuals and families, when approached in a family-centered manner, want their physicians to screen for stressors and unmet social needs, even though it involves answering sensitive questions.
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Not Applicable|
|Study Design ICMJE||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Condition ICMJE||Adverse Childhood Experiences|
|Intervention ICMJE||Other: FRI CLINICAL PROGRAM
University Le Bonheur Pediatric Specialists and Le Bonheur Community Health and Well-Being, Maternal Child Department, have started the Family Resilience Initiative (FRI) in the ULPS General Pediatrics Clinic. This clinical program screens children 9 months to less than five years of age for ACES and SDH at the time of presentation for well child checks. There are two outreach coordinators who screen and enroll children attending clinic for a well-child check during morning clinics 3 to 4 days per week. Children with positive screens for ACES and/or SDH, and their adult caregivers, receive community resource referrals with warm handoffs to vetted organizations. In addition, if indicated, psychological services are offered for children based upon the presence of one or more of ACEs and current health and behavioral problems.
|Study Arms ICMJE||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Not yet recruiting|
|Estimated Enrollment ICMJE
|Original Estimated Enrollment ICMJE||Same as current|
|Estimated Study Completion Date ICMJE||June 2024|
|Estimated Primary Completion Date||June 2022 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
Inclusion Criteria: Experimental group
- 1. Children born at 32 weeks or greater between the ages of 18 to 36 months and their biological mothers.
2. Present to a morning ULPS General Pediatric clinic for a well-child check and newly enrolled that day into the FRI Clinical program (requires at least one ACE or SDH disclosed on screening of child and agrees to clinical program) 3. Mother English speaking
Inclusion Criteria: Control group
4. Previously enrolled in FRI Clinical Program 5. Previously identified serious chronic health problems (e.g. complex congenital heart disease)
|Ages ICMJE||18 Months to 36 Months (Child)|
|Accepts Healthy Volunteers ICMJE||Yes|
|Listed Location Countries ICMJE||Not Provided|
|Removed Location Countries|
|NCT Number ICMJE||NCT04018404|
|Other Study ID Numbers ICMJE||LB_FRI RESEARCH|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||
|IPD Sharing Statement ICMJE||
|Responsible Party||Le Bonheur Children's Hospital|
|Study Sponsor ICMJE||Le Bonheur Children's Hospital|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|PRS Account||Le Bonheur Children's Hospital|
|Verification Date||July 2019|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP