Health and Resilience Projects: Foundations for Substance Use

This study, called HARP: Foundations, is looking at how the Strong African American Families (SAAF) program can help African American youth aged 10-13 stay healthy and avoid substance use. You and your child would be randomly assigned to either receive the SAAF program, which is a 7-session online intervention, or a parenting book called "Parenting for Liberation: A Guide for Raising Black Children." Researchers will measure your child's self-regulation (how well they control their thoughts and actions) and their tolerance for deviance (how much they accept rule-breaking) over two years to see if SAAF is effective. The study is currently enrolling up to 650 participants, including youth and their primary caregivers.

Study design
This is an interventional study where participants are randomly assigned to one of two groups. It plans to enroll 650 participants.
What's involved
Participants will complete baseline and follow-up measures. The SAAF intervention involves 7 online sessions.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for two years, with self-regulation and tolerance for deviance measured at that time.

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NCT05253235

Health and Resilience Projects: Foundations

Recruiting
NAAges 10–13InterventionalPrevention
University of Georgia
~650 participants
Updated 2022-02-23 on ClinicalTrials.gov
What's tested:SAAFReceipt of parenting book

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Self-regulation (youth report)
Measured over Two years
+6 more outcomes measured
Substance Use
1 sites across 1 states
Georgia1
  • Gene H Brody, Ph.D. · PRINCIPAL_INVESTIGATOR · University of Georgia

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Eligibility criteria

Inclusion

Self reported African American or Black;
Age 10-13
Primary caregiver for youth,
Resides in same household as youth.

Exclusion

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).
Conditions (e.g., severe disability, psychoses) that would prevent participation in the SAAF intervention or completing self-report measures.
  • Self-regulation (youth report)Two years

    Youth will complete the the Future-oriented Goals scale and Will's Self-Control scale. We will standardize scores from these two measures (mean =0, standard deviation =1) then average them together. We expect assignment to SAAF vs control to be associated with higher scores (more self-regulation).

  • Self-regulation (parent report)Two years

    Parents will complete a 12 item scale (Humphrey's self control scale) about their youth. Items will be summed ranging from 0-36. We expect assignment to SAAF vs control to be associated with higher scores (more self-regulation).

  • Tolerance for Deviance ScaleTwo years

    Youth will complete the Tolerance for Deviance scale. 19 Items are summed, ranging from 0-57. We expect assignment to SAAF vs Control to be associated with lower scores (reductions in risky attitudes).

  • Reward-based eatingTwo years

    Youth will complete the 13 items Reward Based Eating Drive scale. Scores range from 13-65. SAAF youth are expected to have lower scores on reward based eating compared to control youth.

  • Substance use onsetTwo years

    Lifetime use (yes or no) of alcohol, marijuana, or cigarettes per youth self-report. We will sum the items to form a composite onset index. We expect youth assigned to SAAF to report less substance use onset than youth assigned to control.

  • Past 3 month substance use frequencyTwo years

    Youth complete likert type items assessing alcohol, marijuana, and nicotine use in the past 3 months. Items are standardized and summed to form a substance use composite. We expect youth assigned to SAAF to report less substance use than youth assigned to control.

  • Unhealthy eatingTwo Years

    Youth will complete the Adolescent Food Habits checklist. Items are summed. We expect SAAF youth to engage in less unhealthy eating than control youth.