NCT05033821

Brief Summary

This study's goal is to partner with public libraries to prevent substance use and sexual risk-taking among urban African American adolescents (ages 13-16) affected by parental drug use. An existing universal evidence-based intervention (Focus on Youth with Informed Parents and Children Together, abbreviated as FOY+ImPACT) will be adapted for adolescents affected by parental drug use and delivered in libraries. FOY+ImPACT is a skill-building intervention aimed at preventing substance use and sexual risk-taking among high-risk African American youth. The investigative team will conduct a pilot study to assess the feasibility and initial efficacy of a library-based prevention intervention for adolescents affected by drug use. Participants will be Black adolescents (13-16 years old) affected by parental drug use (N=120). Adolescents will be randomized by partner organization to receive the intervention virtually. Pre, Post and 3-month follow-up data will be collected using computerized surveys. Primary outcomes will be substance use (i.e., marijuana and alcohol use, two of the most common drugs for this age group) and sexual risk behaviors (i.e., initiation of sex and frequency of unprotected sex).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

July 30, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
10 months until next milestone

Study Start

First participant enrolled

July 8, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2023

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

1.1 years

First QC Date

July 30, 2021

Last Update Submit

October 5, 2023

Conditions

Keywords

substance use preventionadolescent healthselective interventioncommunity-based researchparental drug use

Outcome Measures

Primary Outcomes (2)

  • Change in youth substance use based on Youth Risk Behavior Surveillance Survey

    The Youth Risk Behavior Surveillance Survey (YRBS) monitors six categories of health-related behaviors that contribute to the leading causes of death and disability among youth and adults, including alcohol and other drug use. The survey asks about frequency current use (i.e., number of days in the past 30 days) of alcohol and other drugs. Responses for each substance can be "0 days", "1 or 2 days", "3 to 5 days", "6 to 9 days", "10 to 19 days", "20 to 29 days", or "all 30 days".

    baseline, post intervention and 3 months

  • 2. Change in youth sexual risk-taking based on Youth Risk Behavior Surveillance Survey

    The Youth Risk Behavior Surveillance Survey (YRBS) monitors six categories of health-related behaviors that contribute to the leading causes of death and disability among youth and adults, including Sexual behaviors related to unintended pregnancy and sexually transmitted diseases, including HIV infection. The survey asks about initiation of sex and frequency of unprotected sex. Responses for sexual initiation are "yes" or "no". Responses for other contraceptive use at last sex are "I have never had sexual intercourse ", "No method was used to prevent pregnancy", "birth control pills", "Condoms", "An intrauterine device (IUD, such as Mirena or ParaGard) or implant (such as Implanon or Nexplanon)", "A shot (such as Depo-Provera)", "patch (such as Ortho Evra), or birth control ring (such as NuvaRing)", "Withdrawal or some other method", and "Not sure".

    baseline, post intervention and 3 months

Study Arms (2)

Intervention

EXPERIMENTAL

Participants who receive the FOY+ImPACT intervention

Behavioral: Adapted FOY+ImPACT

Control

NO INTERVENTION

Participants who receive standard library programing, but not the FOY+ImPACT intervention.

Interventions

The Adapted FOY+IMPACT is a selective, group-level intervention designed to prevent sexual risk-taking and substance use among adolescents affected by parental drug use. There are eight sessions for youth (FOY) and one session with youth and adults (ImPACT).

Intervention

Eligibility Criteria

Age13 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Black/African American
  • years old
  • have a caregiver with a history of drug use
  • English-speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21212, United States

Location

Related Publications (4)

  • Powell TW, Willis K, Smith B, Lewis Q, Offiong A. "Don't Close the Door on Them": Recruiting and retaining vulnerable Black adolescents in prevention research. J Community Psychol. 2021 Jul;49(5):994-1009. doi: 10.1002/jcop.22584. Epub 2021 May 3.

    PMID: 33937999BACKGROUND
  • Offiong A, Powell TW, Lewis Q, Smith B, Prioleau M. "I missed open arms": The Need for Connectedness among Black Youth Affected by Parental Drug Use. Child Youth Serv Rev. 2020 Jul;114:105072. doi: 10.1016/j.childyouth.2020.105072. Epub 2020 May 8.

    PMID: 32606485BACKGROUND
  • Lewis QJ, Smith BD, Offiong A, Prioleau M, Powell TW. When a house is never a home: Housing instability among youth affected by parental drug abuse. Child Abuse Negl. 2021 Aug;118:105131. doi: 10.1016/j.chiabu.2021.105131. Epub 2021 Jun 9.

    PMID: 34118586BACKGROUND
  • Powell T, Smith BD, Moser N, Kachingwe O, Lewis Wallace Q, Offiong A, Hwang A, Davie E, LoVette A. Adapting a Sexual Health Intervention for Adolescents Exposed to Adversity: Feasibility Study. JMIR Form Res. 2026 Jan 5;10:e72782. doi: 10.2196/72782.

Related Links

MeSH Terms

Conditions

Substance-Related DisordersSexual BehaviorAdolescent Behavior

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersBehavior

Study Officials

  • Terrinieka Powell, PhD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2021

First Posted

September 5, 2021

Study Start

July 8, 2022

Primary Completion

July 31, 2023

Study Completion

August 11, 2023

Last Updated

October 10, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

We do not plan to make individual participant data available to other researchers.

Locations