Clinical trial NCT04501471: The Rural African American's Health Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: SAAF-T
FUEL for Families
Lead sponsor: University of Georgia
Sponsor class: OTHER
First posted: 2020-08-06
Enrollment: 502
Sex: ALL
Minimum age (years): 15
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is an attention controlled randomized clinical trial testing the efficacy of the Strong African American Families-Teen program. The two arm trial tests SAAF-T, a family centered brief intervention against a similarly designed program that targets nutrition and exercise. The outcomes examined include substance use and risky sexual behavior.

Detailed description: In the past, African American adolescents in rural areas have avoided the high-risk behaviors prevalent among youth in urban areas. Recent epidemiologic data, however, indicate that rural African American youth use substances and engage in high-risk sexual behavior at rates equal to or exceeding those in densely populated inner cities (Kogan, Berkel, Chen, Brody, \& Murry, in press; Milhausen et al., 2003). These risk behaviors predict HIV infection, adolescent parenthood, school dropout, involvement with the criminal justice system, and continued substance use during early adulthood (Friedman et al., 1996; Miller, Boyer, \& Cotton, 2004; St. Lawrence \& Scott, 1996; Tucker, Orlando, \& Ellickson, 2003). No developmentally appropriate, culturally sensitive prevention programs have been developed to deter substance use and high-risk sexual behavior among the several million African American adolescents who live in the rural South (Murry \& Brody, 2004). To address this public health need, Drs. Brody and Murry from the University of Georgia and Drs. DiClemente and Wingood from Emory University designed a multicomponent, family-centered prevention program, the Strong African American Families-Teen program (SAAF-T). We conducted a randomized prevention trial to test the program's efficacy. The sample included 502 rural African American families with a 10th-grade student, half of whom will be assigned randomly to a prevention group and half to an attention-control group. Pre-intervention, post-intervention, and long-term follow-up assessments of adolescents' substance use and high-risk sexual behavior were gathered from the entire sample. Specific aims were to test hypotheses that rural African American adolescents randomly assigned to participate in SAAF-T, compared to attention-control participants, will demonstrate lower rates of substance use and risky sexual behavior.

Eligibility criteria: Inclusion Criteria:

* Self-identified Black or African American
* 10th grade in public school in targeted county

Exclusion Criteria:

* Unable to participate in group-based intervention due to mental health

Primary outcomes:
measure: Substance Use
timeFrame: Follow up period baseline to 22 months post-baseline
measure: Risky Sexual Behavior
timeFrame: Follow up period baseline to 22 months post-baseline
Secondary outcomes:
measure: Depressive symptomology- CES-D Scale
timeFrame: Symptoms in past week assessed, follow up period includes baseline to 22 months post baseline
measure: Conduct Problems
timeFrame: Follow up period baseline to 22 months post-baseline
Other outcomes:
measure: Discussion Quality Scale
timeFrame: Follow up period -baseline to 6 month posttest
measure: Family Support Inventory
timeFrame: Follow up period -baseline to 6 month posttest
Locations:
Study officials:
References:
citation: Brody GH, Yu T, Chen E, Miller GE, Barton AW, Kogan SM. Family-Centered Prevention Effects on the Association Between Racial Discrimination and Mental Health in Black Adolescents: Secondary Analysis of 2 Randomized Clinical Trials. JAMA Netw Open. 2021 Mar 1;4(3):e211964. doi: 10.1001/jamanetworkopen.2021.1964.