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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
Sponsor:
Information provided by (Responsible Party):
Le Bonheur Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Adverse Childhood Experiences Other: FRI CLINICAL PROGRAM Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Family Resilience Initiative Research Program
Estimated Study Start Date : July 15, 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2024

Arm Intervention/treatment
No Intervention: Control
Subjects will be approached for enrollment prior to or following clinic visit with physician. Only children present with a biological mother will be considered for enrollment. Charts of controls will be flagged so that they will not be able to be enrolled in the FRI clinical program if they present to a morning clinic where the program is offered.
Experimental: Subject
Mothers and children will be approached by study personnel (separate from Outreach Coordinators who will obtain consent for use of information to evaluate the FRI Clinical Program) for enrollment in the FRI Research Program following completion of all FRI Clinical Program activities for that day. Both mother and child will be enrolled and contribute data and samples to the FRI Research Program.
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.




Primary Outcome Measures :
  1. Change in CBCL score (behavioral measure) [ Time Frame: after 3 years ]
    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.

  2. Changes in BMI from baseline [ Time Frame: after 3 years ]
    We will use changes in BMI to classify child as underweight, normal weight, overweight, obese.

  3. Change in blood pressure percentile from baseline (health measure) [ Time Frame: after 3 years ]
    We will use changes in blood pressure percentile to determine presence of hypertension.

  4. Rate of diagnosis of ADHD (behavioral measure) [ Time Frame: after 3 years ]
    We will use the diagnosis of ADHD to define specific behavioral problems

  5. Percentiles on ASQ domains (developmental measure) [ Time Frame: after 3 years ]
    We will use percentiles on ASQ domains to determine achievement of appropriate developmental milestones.

  6. Measures of Academic Progress testing score (school age) [ Time Frame: after 3 years ]
    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.

  7. Change in Parenting Stress Index score (mother) [ Time Frame: after 3 years ]
    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.

  8. Change in flourishing score (mother) [ Time Frame: after 3 years ]
    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



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Ages Eligible for Study:   18 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Publications of Results:
Other Publications:

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Responsible Party: Le Bonheur Children's Hospital
ClinicalTrials.gov Identifier: NCT04018404    
Other Study ID Numbers: LB_FRI RESEARCH
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD sharing plan is to share data with other researchers as well as The IRB at the University of Tennessee Health Science Center, Le Bonheur Children's Hospital, UT Le Bonheur Pediatric Specialists, Inc., and Urban Child Institute which sponsors and provides funds for this research.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Until the study is complete
Access Criteria: The data will only be given to others to do the research, to study the results, and to see if the research was done correctly.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No