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Completed

NCT Number: NCT04501471

The Rural African American's Health Project

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.

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Key information

Age range

15 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SAAF-T

Behavioral

Parents and youth meet separately during first hour to engage in activities then meet in family groups during the second hours of each session.

Other names: Strong AFrican American Families-Teen Program

Fuel for Families

Behavioral

Parents and youth meet separately during first hour to engage in activities then meet in family groups during the second hours of each session.

Primary outcomes

  1. Substance Use

    Time frame: Follow up period baseline to 22 months post-baseline

    Index of alcohol, cigarette, and marijuana use in the past 3 months

  2. Risky Sexual Behavior

    Time frame: Follow up period baseline to 22 months post-baseline

    Count of unprotected intercourse

Secondary outcomes

  1. Depressive symptomology- CES-D Scale

    Time frame: Symptoms in past week assessed, follow up period includes baseline to 22 months post baseline

    Symptoms of depression, 20 items

  2. Conduct Problems

    Time frame: Follow up period baseline to 22 months post-baseline

    Using 14 questions from the National Youth Survey,adolescents indicated the frequency during the past 6 months with which they had fought, stolen, been truant from school, or been suspended from school. Adolescents' responses were summed, and the sum constituted the conduct problems score.13

Other outcomes

  1. Discussion Quality Scale

    Time frame: Follow up period -baseline to 6 month posttest

    The DQS assessed communication frequency and quality for discussions of difficult issues.

  2. Family Support Inventory

    Time frame: Follow up period -baseline to 6 month posttest

    The FSI measured provision of emotional support, involvement, and quality of caregiver-youth communication

Sponsors and collaborators

Lead sponsor

University of Georgia

Other

Registry information

Acronym: RAAFHP

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Aug 6, 2020
Registry last updated
Aug 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.