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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the Strong African American Families (SAAF) program can improve the health and well-being of African American adolescents by reducing their vulnerability to substance use. Families will either participate in a seven-week online program or receive a parenting guidebook. The trial seeks African American youth aged 10-13 and their primary caregivers who live together. Participants should not have conditions that affect stress response, such as diabetes or asthma. As an unphased trial, this study offers families the chance to contribute to research that may enhance adolescent health and resilience.

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 prior data suggests that the SAAF intervention is safe for adolescents?

Research shows that the Strong African American Families (SAAF) program is well-received. Designed for young people aged 10-14 and their caregivers, it includes seven weekly sessions. Studies have found that the program helps reduce risky behaviors like alcohol and drug use. Importantly, participants have reported no negative effects, suggesting that the SAAF program is safe for teens and their families. By focusing on improving health and resilience, the program appears to achieve its goals without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The SAAF intervention is unique because it focuses on a family-centered approach to boost adolescent well-being through online sessions. Unlike traditional treatments that might involve medication or individual therapy, SAAF involves both parents and youth in a collaborative setting, fostering communication and support within the family. Researchers are excited about this approach as it has the potential to strengthen family bonds and provide adolescents with a supportive environment, which can be crucial for their mental health and development. Additionally, the convenience of an online format ensures wider accessibility and engagement, catering to the needs of modern families.

What evidence suggests that the SAAF intervention is effective for promoting the well-being of African American adolescents?

Research has shown that the Strong African American Families (SAAF) program, which participants in this trial may receive, can help reduce risky behaviors in teenagers. Studies have found that young people who participated in the SAAF program used alcohol and drugs less often than those who did not. Additionally, teens in the SAAF program exhibited fewer behavior problems over time. The program improves family interactions and helps parents guide their children to make good choices. This evidence suggests that SAAF can support better health and resilience in African American teens. ^{1 3 5 6 7}

Who Is on the Research Team?

Gene H Brody, Ph.D.

Principal Investigator

University of Georgia

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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-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 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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11178634/

The Strong African American Families Program This study tests the efficacy of a culturally tailored preventive intervention for rural African American families to disrupt the negative consequences of ...

2. plataformadeevidencias.iadb.org plataformadeevidencias.iadb.org/en/casos-avaliados/strong-african-american-families-program-saaf

Strong African American Families Program (SAAF) Significant improvements were observed in the reduction of youth risk behaviors, such as use of alcohol [1] [2] [3] [5] [7] [9] [10] [11] and other drugs [11], ...

3. cebc4cw.org cebc4cw.org/program/strong-african-american-families-program/

Strong African American Families Program (SAAF) Results indicate that compared with adolescents in the control condition, fewer youth in the SAAF group increased their involvement in conduct problems over ...

4. blueprintsprograms.org blueprintsprograms.org/programs/168999999/strong-african-american-families-program/

Strong African American Families Program The SAAF program is designed to strengthen positive family interactions and to enhance parents' efforts to help their children establish and reach positive ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1054139X07001723

The Strong African American Families Program The SAAF program was developed as an empirically based, preventive intervention tailored to this population's unique context.

6. cfr.uga.edu cfr.uga.edu/saaf-programs/saaf/

Strong African American Families Program The Strong African American Families (SAAF) Program is a 7 session program designed for youth aged 10–14 and their caregivers.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0376871613003207

Cost-effectiveness of the strong African American families ... The SAAF-T intervention provides a potentially cost-effective means for reducing the African American youths' alcohol use and binge drinking episodes.