SAAF Program for Adolescent Well-Being

(HARP-F Trial)

Overseen By Cara Hodge, BS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Georgia

Disqualifiers: Chronic illnesses, Severe disability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

650 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if participants must stop taking their current medications, but youth with chronic illnesses or medication regimens affecting inflammatory panels are excluded.

What data supports the effectiveness of the SAAF Program for Adolescent Well-Being treatment?

Research shows that the Strong African American Families (SAAF) program effectively reduces alcohol use and deters substance use, conduct problems, and depressive symptoms in African American adolescents. The program's long-term benefits include lower rates of alcohol use and improved family relationships, which contribute to better adolescent well-being. ^{1 2 3 4 5}

Is the SAAF program safe for participants?

The SAAF program, including its variations like SAAF-T and ProSAAF, has been studied in several trials and no safety concerns have been reported. These programs focus on family and couple-centered interventions and have shown benefits in areas like reducing substance use and improving mental health without any noted adverse effects. ^{1 3 4 5 6}

How is the SAAF treatment different from other treatments for adolescent well-being?

The SAAF program is unique because it is a family-centered intervention specifically designed for African American adolescents, focusing on improving family communication and parenting skills to prevent high-risk behaviors, substance use, and depressive symptoms. Unlike other treatments, it includes a specific component for teaching condom skills and is delivered in community settings over seven sessions. ^{1 3 4 5 7}

Research Team

Gene H Brody, Ph.D.

Principal Investigator

University of Georgia

Eligibility Criteria

This trial is for African American adolescents aged 10-13 and their primary caregivers. Caregivers must be the youth's primary guardian and live in the same household. Those with severe disabilities, psychoses, or conditions affecting participation are excluded, as are youths with MRI contraindications or chronic illnesses impacting inflammatory panels.

Inclusion Criteria

I am African American or Black, aged between 10 and 13.

Parents: Primary caregiver for youth, Resides in same household as youth

Exclusion Criteria

Parent: Conditions (e.g., severe disability, psychoses) that would prevent participation in the SAAF intervention or completing self-report measures.

I cannot have an MRI due to metal in my body, a brain injury, fear of tight spaces, or being pregnant. I also do not have chronic illnesses like diabetes or asthma that would affect blood tests.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pretest Assessment

Eligible participants undergo assessments including MRI scans, blood draws, and self-report measures

1 week

1 visit (in-person)

Intervention

Participants receive the SAAF intervention consisting of 7 weekly online sessions

7 weeks

7 visits (virtual)

Control

Control group receives written information by mail regarding adolescent development

7 weeks

Follow-up

Participants are monitored for changes in NIN-associated risk markers and other outcomes

2 years

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• Receipt of Parenting Book
• SAAF

Trial Overview The Health and Resilience Project: Foundations is testing the Strong African American Families (SAAF) program to see if it helps prevent substance abuse among young African Americans. Participants will either receive SAAF or a parenting book, and their stress coping abilities based on a neuroimmune model will be assessed.

Participant Groups

Group I: SAAF Intervention Experimental Treatment 1 Intervention

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

Group II: Control Group Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Georgia

Lead Sponsor

Trials

109

Recruited

43,500+

Findings from Research

The Strong African American Families-Teen (SAAF-T) program effectively reduced increases in conduct problems, substance use, and depressive symptoms among 502 rural black adolescents over a 22-month period.

This study is the first to show that a structured, family-centered intervention can prevent these issues in this demographic, making it a promising option for public health initiatives and community organizations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-centered program deters substance use, conduct problems, and depressive symptoms in black adolescents. Brody, GH., Chen, YF., Kogan, SM., et al.[2023]

The Protecting Strong African American Families (ProSAAF) program positively influenced children's outcomes indirectly by improving couple functioning and parent-child relationships, as shown in a study with 346 African American couples over more than 2 years.

While the program did not show direct effects on children's outcomes, the improvements in couple dynamics and parenting suggest that couple-focused interventions could be beneficial for children's well-being in the long run.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Direct and indirect effects of a couple-focused preventive intervention on children's outcomes: A randomized controlled trial with African American families. Lavner, JA., Barton, AW., Beach, SRH.[2022]

The Strong African American Families-Teen (SAAF-T) program effectively reduced unprotected intercourse and increased condom efficacy among 502 rural African American adolescents, demonstrating its potential as a preventive intervention.

About 70% of participants attended the optional condom skills unit, and those with religious caregivers were more likely to participate, indicating that family dynamics can influence attendance in sexual health education programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating condom skills into family-centered prevention: efficacy of the Strong African American Families-Teen program. Kogan, SM., Yu, T., Brody, GH., et al.[2021]

The Strong African American Families (SAAF) program effectively reduced alcohol use among African American youth, with a significant treatment effect observed in participants who completed all 7 sessions, showing a large reduction in alcohol use growth (β = -.83, p < .001).

Participants who attended at least 5 out of the 7 sessions experienced a medium-sized effect in slowing alcohol use growth (d = 1.51), highlighting the importance of engagement in the program for achieving optimal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-centered alcohol use prevention for African American adolescents: A randomized clinical trial. Kogan, SM., Bae, D., Lei, MK., et al.[2023]

The Strong African American Families (SAAF) program significantly reduced alcohol use among rural African American youths over a 65-month period, with participants drinking alcohol half as often as those in the control group.

The program's early intervention in protective parenting and self-regulatory skills helped deter the initiation of alcohol use, leading to sustained lower rates of alcohol consumption into adolescence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effects of the strong African American families program on youths' alcohol use. Brody, GH., Chen, YF., Kogan, SM., et al.[2023]

The ProSAAF program, designed for African-American couples, showed significant improvements in couple functioning, which indirectly led to better health outcomes for participants 25 months after enrollment.

While there were no direct effects of ProSAAF on health changes, improvements in couple functioning positively influenced general health, depressive symptoms, and sleep quality for both men and women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Interventions that Strengthen Couples' Relationships Confer Additional Benefits for their Health? A Randomized Controlled Trial with African American Couples. Barton, AW., Lavner, JA., Beach, SRH.[2022]

The Strong African American Families Program (SAAF) was effective in improving parenting practices among 332 participating families, leading to better communication and regulation in parenting.

Youth participants reported lower rates of high-risk behaviors, which were linked to their recognition of improved parenting, suggesting that enhancing parenting skills can positively influence youth behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The strong African American families program: prevention of youths' high-risk behavior and a test of a model of change. Brody, GH., Murry, VM., Gerrard, M., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Family-centered program deters substance use, conduct problems, and depressive symptoms in black adolescents. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Direct and indirect effects of a couple-focused preventive intervention on children's outcomes: A randomized controlled trial with African American families. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Integrating condom skills into family-centered prevention: efficacy of the Strong African American Families-Teen program. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Family-centered alcohol use prevention for African American adolescents: A randomized clinical trial. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Long-term effects of the strong African American families program on youths' alcohol use. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Can Interventions that Strengthen Couples' Relationships Confer Additional Benefits for their Health? A Randomized Controlled Trial with African American Couples. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The strong African American families program: prevention of youths' high-risk behavior and a test of a model of change. [2022]