NCT03590132

Brief Summary

The most common approach to preventing alcohol use involves providing a well-designed program in preadolescence just prior to or upon entering middle school. This approach does not have long-lasting effects or address the risk factors that lead many youth to use alcohol in high school. This study tested a strategy that compares offering effective programs at the transition to middle school and the transition to high school with only offering a program at either one of the transitions or no programs at all.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
472

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2012

Longer than P75 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2012

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 18, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

June 19, 2019

Status Verified

June 1, 2019

Enrollment Period

6 years

First QC Date

June 12, 2018

Last Update Submit

June 17, 2019

Conditions

Keywords

adolescentalcoholfamily-centered preventionAfrican American

Outcome Measures

Primary Outcomes (3)

  • Alcohol use in past 3 months (single item)

    Youth complete this single item from Monitoring the Future Study assessing the frequency of alcohol use in the past 3 months. There is an ordinal response scale ranging from 0 (none) to 6 (30 or more times). Higher response numbers indicate a worse outcome (more alcohol use).

    3 months

  • Frequency of cannabis use in the past 3 months (single item)

    Single item from Monitoring the Future Study assessing frequency of marijuana use in the past 3 months. There is an ordinal response scale ranging from 0 (none) to 6 (30 or more times). Higher responses indicate a worse outcome (more marijuana use in the past 3 months).

    3 months

  • Monitoring the Future: Total substance use (summative index of use of alcohol, cannabis, and nicotine)

    Youth complete 3 single items from the Monitoring the Future study indexing the frequency of their use of alcohol, cannabis, and nicotine in past 3 months. There is an ordinal response scale ranging from 0 (none) to 6 (30 or more times) for each item. The three items are summed yielding a scale ranging from 0-18. Higher response numbers indicate a worse outcome (more substance use).

    3 months

Secondary Outcomes (3)

  • Center for Epidemiological studies-Depression scale

    Past 7 days

  • The National Survey of Adolescents Conduct Problems Subscale

    past 3 months

  • Center for Epidemiological Studies-Depression Scale-Child Version

    past 7 days

Study Arms (4)

SAAF

EXPERIMENTAL

participants in this arm receive the SAAF intervention at age 11-12.

Behavioral: Strong African American Families Program

SAAF-T

EXPERIMENTAL

participants in this arm receive the SAAF-Teen intervention at age 14-15.

Behavioral: Strong African American Families--Teen Program

SAAF SAAF-T

EXPERIMENTAL

participants in this arm receive SAAF at age 11-12 and later receive SAAF-Teen at age 14-15

Behavioral: Strong African American Families ProgramBehavioral: Strong African American Families--Teen Program

Control

NO INTERVENTION

These participants receive no interventions.

Interventions

SAAF is a 7 session family skills training program

Also known as: SAAF
SAAFSAAF SAAF-T

SAAF-T is a 5 session family skills training program

Also known as: SAAF--T
SAAF SAAF-TSAAF-T

Eligibility Criteria

Age11 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • self reported African American
  • th grade

You may not qualify if:

  • unable to attend a family-centered prevention intervention due to incapacitation of youth
  • unable to attend a family-centered prevention intervention due to incapacitation of youth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Kogan SM, Reck AJ, Tiwari B, Thapha JR, Carter S, Oshri A, Koss K, Ahn SJ, Beach S, Fisher S, Smith E, Zhang L. Family-Centered Prevention Attenuates the Association Between Structural Racism Risk and Black Adolescents' Low Self-regulation and Externalizing Behaviors: Secondary Analysis of a Randomized Clinical Trial. Prev Sci. 2025 Aug;26(6):932-942. doi: 10.1007/s11121-025-01828-5. Epub 2025 Jul 17.

  • Kogan SM, Kwon E, Brody GH, Azarmehr R, Reck AJ, Anderson T, Sperr M. Family-Centered Prevention to Reduce Discrimination-Related Depressive Symptoms Among Black Adolescents: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Nov 1;6(11):e2340567. doi: 10.1001/jamanetworkopen.2023.40567.

MeSH Terms

Conditions

Underage Drinking

Condition Hierarchy (Ancestors)

Adolescent BehaviorBehaviorAlcohol DrinkingDrinking Behavior

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Neither the interventionists or the assessors were given information on participants' treatment group; however there is only partial masking for providers given that attendance in the program suggests some information on experimental group.
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: A 4 arm trial, participants receive either a preadolescent intervention only, a mid-adolescent intervention only, both preadolescent and mid-adolescent intervention, or no intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 12, 2018

First Posted

July 18, 2018

Study Start

December 10, 2012

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

June 19, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Participants have not consented to data being shared outside of research team