Health and Resilience Projects: Foundations

NCT05253235 | Recruiting

• 1 other identifier: PROJECT00003530
• Study Type: interventional
• Target: 650
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Use

Outcome Measures

Primary Outcomes (7)

• Self-regulation (youth report)

  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).

  Two years

• Self-regulation (parent report)

  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).

  Two years

• Tolerance for Deviance Scale

  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).

  Two years

• Reward-based eating

  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.

  Two years

• Substance use onset

  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.

  Two years

• Past 3 month substance use frequency

  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.

  Two years

• Unhealthy eating

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

  Two Years

Secondary Outcomes (10)

• Involved Vigilant Parenting Scale (youth report)

  1 year

• Involved Vigilant Parenting (parent report)

  1 year

• Cultural socialization (youth report)

  1 year

• Cultural socialization (parent report)

  1 year

• Communication about Risk Behavior (youth report)

  1 year

Study Arms (2)

SAAF Intervention

EXPERIMENTAL

Parents and youth will receive an online, family-centered intervention consisting of 7 weekly sessions.

Behavioral: SAAF

Control Group

OTHER

Control group members will receive a book entitled, Parenting for Liberation: A Guide for Raising Black Children

Other: Receipt of parenting book

Interventions

SAAF BEHAVIORAL

A 7 session online intervention designed to augment protective processes associated with deterrence of substance use

SAAF Intervention

Receipt of parenting book OTHER

Parents will receive a copy of the book, Parenting for Liberation: A Guide for Raising Black Children

Control Group

Eligibility Criteria

• Age: 10 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Georgia: lead

Study Sites (1)

Center for Family Research

Athens, Georgia, 30602, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Gene H Brody, Ph.D.

  University of Georgia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Zuercher, MPH

CONTACT

706-425-2992; zuercher@uga.edu

Cara Hodge, BS

CONTACT

706-425-2992; thodge@uga.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessment staff will be blind to families' experimental assignment at pretest.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Regents Professor

Model Details: Participants are randomly assigned to a preventive intervention or a no treatment control

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: February 23, 2022
• Study Start: January 25, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 23, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Available 9 months to 36 months after article publication
• Access Criteria: Investigators working under an institution with a Federal Wide Assurance (FWA) and have received approval from a certified Institutional Review Board may request data.

Locations

US (1)