Adverse Childhood Experiences Clinical Trial
Official title:
Family Resilience Initiative Research Program
Verified date | July 2019 |
Source | Le Bonheur Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 400 |
Est. completion date | June 2024 |
Est. primary completion date | June 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Months to 36 Months |
Eligibility |
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 Exclusion Criteria: - 1. Previously enrolled in FRI Clinical Program 2. Previously enrolled as a control in an afternoon clinic 3. Previously identified serious chronic health problems (e.g. complex congenital heart disease) Inclusion Criteria: Control group 1. Children born at 32 weeks or greater between the ages of 18 to 36 months and their biological mothers. 2. Presenting to an afternoon ULPS General Pediatric clinic for a well- child check 3. Has at least one ACE or SDH on pre-enrollment screening 4. Mother English speaking Exclusion Criteria: 4. Previously enrolled in FRI Clinical Program 5. Previously identified serious chronic health problems (e.g. complex congenital heart disease) |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Le Bonheur Children's Hospital |
Argentieri MA, Nagarajan S, Seddighzadeh B, Baccarelli AA, Shields AE. Epigenetic Pathways in Human Disease: The Impact of DNA Methylation on Stress-Related Pathogenesis and Current Challenges in Biomarker Development. EBioMedicine. 2017 Apr;18:327-350. d — View Citation
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Bick J, Naumova O, Hunter S, Barbot B, Lee M, Luthar SS, Raefski A, Grigorenko EL. Childhood adversity and DNA methylation of genes involved in the hypothalamus-pituitary-adrenal axis and immune system: whole-genome and candidate-gene associations. Dev Psychopathol. 2012 Nov;24(4):1417-25. doi: 10.1017/S0954579412000806. Review. — View Citation
Bright MA, Knapp C, Hinojosa MS, Alford S, Bonner B. The Comorbidity of Physical, Mental, and Developmental Conditions Associated with Childhood Adversity: A Population Based Study. Matern Child Health J. 2016 Apr;20(4):843-53. doi: 10.1007/s10995-015-1915-7. — View Citation
Bright MA, Thompson L, Esernio-Jenssen D, Alford S, Shenkman E. Primary Care Pediatricians' Perceived Prevalence and Surveillance of Adverse Childhood Experiences in Low-Income Children. J Health Care Poor Underserved. 2015 Aug;26(3):686-700. doi: 10.1353/hpu.2015.0080. — View Citation
Chung EK, Siegel BS, Garg A, Conroy K, Gross RS, Long DA, Lewis G, Osman CJ, Jo Messito M, Wade R Jr, Shonna Yin H, Cox J, Fierman AH. Screening for Social Determinants of Health Among Children and Families Living in Poverty: A Guide for Clinicians. Curr Probl Pediatr Adolesc Health Care. 2016 May;46(5):135-53. doi: 10.1016/j.cppeds.2016.02.004. Epub 2016 Apr 18. Review. — View Citation
Denhardt DT. Effect of stress on human biology: Epigenetics, adaptation, inheritance, and social significance. J Cell Physiol. 2018 Mar;233(3):1975-1984. doi: 10.1002/jcp.25837. Epub 2017 Apr 27. Review. — View Citation
Gottlieb L, Hessler D, Long D, Amaya A, Adler N. A randomized trial on screening for social determinants of health: the iScreen study. Pediatrics. 2014 Dec;134(6):e1611-8. doi: 10.1542/peds.2014-1439. Epub 2014 Nov 3. — View Citation
Gottlieb LM, Hessler D, Long D, Laves E, Burns AR, Amaya A, Sweeney P, Schudel C, Adler NE. Effects of Social Needs Screening and In-Person Service Navigation on Child Health: A Randomized Clinical Trial. JAMA Pediatr. 2016 Nov 7;170(11):e162521. doi: 10.1001/jamapediatrics.2016.2521. Epub 2016 Nov 7. — View Citation
Gottlieb LM, Wing H, Adler NE. A Systematic Review of Interventions on Patients' Social and Economic Needs. Am J Prev Med. 2017 Nov;53(5):719-729. doi: 10.1016/j.amepre.2017.05.011. Epub 2017 Jul 5. Review. — View Citation
Jimenez ME, Wade R Jr, Lin Y, Morrow LM, Reichman NE. Adverse Experiences in Early Childhood and Kindergarten Outcomes. Pediatrics. 2016 Feb;137(2):e20151839. doi: 10.1542/peds.2015-1839. Epub 2016 Jan 14. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in CBCL score (behavioral measure) | We will use the CBCL scores (total, internalizing and subscales, externalizing and subscales) to define behavior problems. Since we expect a high rate of loss to follow up during the study, we plan to recruit 195 subjects in each arm to account for up to 50% loss to follow up. Our target population for the primary outcome will therefore be 390. | after 3 years | |
Primary | Changes in BMI from baseline | We will use changes in BMI to classify child as underweight, normal weight, overweight, obese. | after 3 years | |
Primary | Change in blood pressure percentile from baseline (health measure) | We will use changes in blood pressure percentile to determine presence of hypertension. | after 3 years | |
Primary | Rate of diagnosis of ADHD (behavioral measure) | We will use the diagnosis of ADHD to define specific behavioral problems | after 3 years | |
Primary | Percentiles on ASQ domains (developmental measure) | We will use percentiles on ASQ domains to determine achievement of appropriate developmental milestones. | after 3 years | |
Primary | Measures of Academic Progress testing score (school age) | Using the RIT (Rasch Units) to chart the students academic growth from year to year. Will be available once child has entered school and will be used to determine school readiness. | after 3 years | |
Primary | Change in Parenting Stress Index score (mother) | We will use Parenting Stress Index to determine the level of parental stress. The PSI 120 item inventory that focuses on three major domains of stress (child characteristics, parent characteristics, and situational/demographic life stress. | after 3 years | |
Primary | Change in flourishing score (mother) | This scale is used around the world to assess various domains of flourishing, or human well being. We will use changes in flourishing score to determine maternal well being | after 3 years |
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