Clinical trial NCT04510116: Adults In The Making Prevention Trial
Official title: Preventing Alcohol Use Among African American Youths
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Lead sponsor: University of Georgia
Sponsor class: OTHER
First posted: 2020-08-12
Enrollment: 367
Sex: ALL
Minimum age (years): 17
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was a randomized prevention trial investigating the efficacy of the Adults in the Making (AIM) prevention program against a control condition. The primary outcome variable is alcohol use. The study sample were 367 African American seniors in high school and their primary caregivers. The AIM program is a 6 session (12 hour) family-centered intervention designed to deter alcohol use.

Detailed description: The study investigators designed a multicomponent prevention program to deter substance use among African American emerging adults in rural Georgia (SAAF-Emerging Adult Program, SAAF-EAP). The intervention's delivery is modeled after an existing prevention program designed by Dr. Brody called, The Strong African American Families (SAAF) program and included a series of separate weekly sessions for emerging adults, their parents, and extended family members, as well as sessions in which participants interact with one another to apply the skills learned in the separate sessions. The sample consisted of 690 families with a high school senior, half of whom will be assigned randomly to a prevention group and half of whom will be assigned to a control group. Pre-intervention, post-intervention, and follow-up assessments of emerging adults' substance use were conducted with the entire sample. The study started when the participants were high school seniors, and followed them and their families as the youths enter emerging adulthood. The conceptual model that guided the program incorporated the following predictors: (1) autonomy-promoting parenting and responsive family relationships, characterized by developmentally appropriate instrumental and emotional support, expectations and discussions about emerging adults' roles and responsibilities, affectively positive relationships that feature open communication, and adaptive racial socialization that includes strategies for dealing with discrimination; (2) contextual stressors, including racial discrimination, poverty, and limitations in educational and occupational opportunities; (3) negative emotions and the avoidant coping responses they elicit; (4) emerging adults' future orientation, self-regulation, emotion regulation, racial identity, and sense of adult status; (5) affiliations with substance-using friends and romantic partners; and (6) cognitive antecedents of substance use, including prototypes of substance-using agemates and willingness to use substances in risk-conducive situations. To examine these constructs, the investigators implemented a multi-informant design that included assessments from emerging adults, their friends and romantic partners, their primary caregivers, and their extended family members.

Eligibility criteria: Inclusion Criteria:

* Residence in county where sampling was targeted
* Youth self identified as African American or Black

Exclusion Criteria:

* Unable to complete survey measures or participate in intervention due to mental health concerns

Primary outcomes:
measure: Alcohol use
timeFrame: follow up at 27 months post baseline
measure: Conduct problems
timeFrame: follow up at 27 months post baseline
Secondary outcomes:
measure: Depressive symptoms
timeFrame: follow up at 27 months post baseline
measure: Protective caregiving
timeFrame: follow up at 6 months post baseline
Other outcomes:
Locations:
Study officials:
affiliation: University of Georgia
name: Gene Brody, PhD
role: PRINCIPAL_INVESTIGATOR
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.