Health and Resilience Projects: Foundations

NCT ID: NCT05253235

Last Updated: 2022-02-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 650 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-25
• Study Completion Date: 2027-12-31

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.

Conditions

Substance Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

SAAF Intervention

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

Group Type: EXPERIMENTAL

SAAF

Intervention Type: BEHAVIORAL

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

Control Group

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

Group Type: OTHER

Receipt of parenting book

Intervention Type: OTHER

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

Interventions

SAAF

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

Intervention Type: BEHAVIORAL

Receipt of parenting book

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Georgia

OTHER

Sponsor Role: lead

Responsible Party

Gene H. Brody

Regents Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gene H Brody, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Georgia

Locations

Center for Family Research

Athens, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Heather Zuercher, MPH

Role: CONTACT

zuercher@uga.edu

706-425-2992

Cara Hodge, BS

Role: CONTACT

thodge@uga.edu

706-425-2992

Facility Contacts

Cara Hodge, BS

Role: primary

thodge@uga.edu

706-425-2992

Other Identifiers

PROJECT00003530

Identifier Type: -

Identifier Source: org_study_id