Health and Resilience Projects: Foundations
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SAAF, Receipt of parenting book.
- Who it may be relevant to
- Registry conditions: Substance Use. Basic parameters: 10 years — 13 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Can Family-Centered Prevention Programming Reduce Neuroimmune Vulnerabilities for Drug Use and Cardiometabolic Risk Among African American Adolescents? A Randomized Prevention Trial
Overview
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.
Interventions
- Behavioral SAAF
A 7 session online intervention designed to augment protective processes associated with deterrence of substance use - Other Receipt of parenting book
Parents will receive a copy of the book, Parenting for Liberation: A Guide for Raising Black Children
Primary outcome measures
- Self-regulation (youth report) [Time frame: Two years]
- Self-regulation (parent report) [Time frame: Two years]
- Tolerance for Deviance Scale [Time frame: Two years]
- Reward-based eating [Time frame: Two years]
- Substance use onset [Time frame: Two years]
- Past 3 month substance use frequency [Time frame: Two years]
- Unhealthy eating [Time frame: Two Years]
Secondary outcome measures (10)
- Involved Vigilant Parenting Scale (youth report) [Time frame: 1 year]
- Involved Vigilant Parenting (parent report) [Time frame: 1 year]
- Cultural socialization (youth report) [Time frame: 1 year]
- Cultural socialization (parent report) [Time frame: 1 year]
- Communication about Risk Behavior (youth report) [Time frame: 1 year]
- Communication about risk behavior (parent report) [Time frame: 1 year]
- Threat sensitivity via functional MRI assessment [Time frame: Two years]
- Executive control assessed via functional MRI assessment [Time frame: Two years]
- Reward sensitivity via functional MRI assessment [Time frame: Two years]
- Peripheral inflammation composite score [Time frame: Two years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Center for Family Research — Athens
Publications
- Kogan SM, Anderson T, Yu T, Fisher S, Ahn SJG, Beach SRH. Behavioral Effects of a Telehealth Family Prevention Program for Black Adolescents: 2 Year Results of a Randomized Trial. J Prev (2022). 2026 Aug 1. doi: 10.1007/s10935-026-00939-1. Online ahead of print. PMID 42541642
Identifiers
NCT: NCT05253235 · PROJECT00003530