Clinical trial NCT05253235: Health and Resilience Projects: Foundations
Official title: Can Family-Centered Prevention Programming Reduce Neuroimmune Vulnerabilities for Drug Use and Cardiometabolic Risk Among African American Adolescents? A Randomized Prevention Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Substance Use
Lead sponsor: University of Georgia
Sponsor class: OTHER
First posted: 2022-02-23
Enrollment: 650
Sex: ALL
Minimum age (years): 10
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to a preventive intervention or a no treatment control
Primary purpose: PREVENTION

Brief summary: The Health and Resilience Project (HARP): Foundations is investigating the efficacy of the Strong African American Families (SAAF) intervention in promoting the health and well being of African American adolescents. Youth age 10-13 and their primary caregivers are randomly assigned to receive SAAF or to a control group. Participants complete baseline and follow-up measures regarding vulnerability to substance use based on a neuroimmune model of stress coping.

Detailed description: During childhood and adolescence, family relationships play critical roles in regulating physiological stress reactions. This protects the developing brain from the potentially deleterious effects of stress hormones and neurochemicals. In a series of proof-of-principle studies, the investigators studied the potential for the Strong African American Families (SAAF) drug use prevention program delivered when youth were age 11 to protect participants from the consequences of social adversity when they were transitioning to adulthood (ages 19-25). Effects were detected on a range of outcomes associated with neuroimmune (NIN) dysregulation including inflammation, the neural structure of limbic regions, prefrontal-limbic connectivity, and cardiometabolic health. Although these findings are provocative, the SAAF trial was not designed to evaluate mechanisms and outcomes that the NIN model suggested. Data on inflammation and neural activity were collected post hoc, many years after the intervention concluded. Thus these findings must be regarded as preliminary until a more rigorous study is performed with pretest and posttest measures of NIN processes. The proposed prevention trial of SAAF (N = 325) is designed to meet this need.

Our specific aims are to test hypotheses regarding:

1. the influence of participation in SAAF on change in NIN-associated risk markers (neural circuitry subserving threat, reward, and executive control, as well as peripheral inflammation) across 2 years;
2. the mediating role of protective parenting in linking intervention participation to NIN-associated risk markers;
3. the influence of participation in SAAF on change in addictive behavior vulnerabilities associated with risky decision making, emotion regulation, early-onset substance use, unhealthy eating, and cardiometabolic risk markers; and
4. the mediational chain linking SAAF to addictive behavior vulnerabilities via changes in parenting and NIN-associated risk markers.

A sample of 325 African American youth and their primary caregivers will be recruited from Athens, GA and surrounding areas. Inclusion criteria are (a) youth or parent self-designates as African American, Black, or biracial (including Black or African American), and (b) youth is in 5th grade and 10-13 years of age. Exclusion criteria include: (a) contraindications for MRI scanning (e.g., metal in body, traumatic brain injury, claustrophobia, pregnancy), (b) youth with chronic illnesses or medication regimens that would affect inflammatory panels (e.g., diabetes, congenital heart disease, asthma, cancers), and (c) parent or youth conditions (e.g., ADHD, psychoses) that would prevent participation in the SAAF intervention. Given the nonverbal nature of fMRI tasks, left-handed youth are not excluded. The investigators anticipate screening \~615 families over a 2.5-year period to obtain a sample of 325 families. Eligible participants will be scheduled for an assessment at UGA's Bioimaging Research Center. Youth will participate in a scan (\~60 minutes), a blood draw, and youth and parents will complete self-report measures. At each data collection wave, parents consent in writing to their own and their children's participation and children provide written assent. At W2, a home visit is made with laptop computers to collect self-report data. After pretest, families will be assigned randomly to SAAF or control. Control families receive written information by mail regarding adolescent development.

Eligibility criteria: Inclusion Criteria:

Youth:

* Self reported African American or Black;
* Age 10-13

Parents:

* Primary caregiver for youth,
* Resides in same household as youth.

Exclusion Criteria:

Youth :

* Contraindications for MRI scanning (e.g., metal in body, traumatic brain injury, claustrophobia, pregnancy),
* Youth with chronic illnesses or medication regimens that would affect inflammatory panels (e.g., diabetes, congenital heart disease, asthma, cancers).

Parent:

* Conditions (e.g., severe disability, psychoses) that would prevent participation in the SAAF intervention or completing self-report measures.

Primary outcomes:
measure: Self-regulation (youth report)
timeFrame: Two years
measure: Self-regulation (parent report)
timeFrame: Two years
measure: Tolerance for Deviance Scale
timeFrame: Two years
measure: Reward-based eating
timeFrame: Two years
measure: Substance use onset
timeFrame: Two years
measure: Past 3 month substance use frequency
timeFrame: Two years
measure: Unhealthy eating
timeFrame: Two Years
Secondary outcomes:
measure: Involved Vigilant Parenting Scale (youth report)
timeFrame: 1 year
measure: Involved Vigilant Parenting (parent report)
timeFrame: 1 year
measure: Cultural socialization (youth report)
timeFrame: 1 year
measure: Cultural socialization (parent report)
timeFrame: 1 year
measure: Communication about Risk Behavior (youth report)
timeFrame: 1 year
measure: Communication about risk behavior (parent report)
timeFrame: 1 year
measure: Threat sensitivity via functional MRI assessment
timeFrame: Two years
measure: Executive control assessed via functional MRI assessment
timeFrame: Two years
measure: Reward sensitivity via functional MRI assessment
timeFrame: Two years
measure: Peripheral inflammation composite score
timeFrame: Two years
Other outcomes:
Locations:
city: Athens
country: United States
facility: Center for Family Research
state: Georgia
Study officials:
affiliation: University of Georgia
name: Gene H Brody, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: