A Library-based Prevention Intervention for Adolescents Affected by Parental Drug Use

October 5, 2023 updated by: Johns Hopkins Bloomberg School of Public Health
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

With nearly 17,000 public libraries nationwide and four million visits each day, libraries have extensive population reach. Libraries are an ideal partner because they are stable, safe, accessible, confidential community spaces with a low barrier to entry and non-judgmental staff. 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.

For this study, a 'parent with a history of drug use' is defined as a biological parent who abused an illicit drug for longer than 1 month in the past 2 years. This group includes parents in recent recovery and those enrolled in substance abuse treatment programs. Many youth affected by parental drug use live with someone who does not use drugs, extended family members, or are in the care of social services. Thus, primary caregivers will be eligible to participate in the absence of a biological parent. A 'primary caregiver', is defined as a person who regularly provides care for a child that is not their birth child.

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).

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21212
        • Johns Hopkins Bloomberg School of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Black/African American
  • 13-16 years old
  • have a caregiver with a history of drug use
  • English-speaking

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Participants who receive the FOY+ImPACT intervention
Behavioral: Adapted FOY+ImPACT
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).
No Intervention: Control
Participants who receive standard library programing, but not the FOY+ImPACT intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in youth substance use based on Youth Risk Behavior Surveillance Survey
Time Frame: baseline, post intervention and 3 months
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
Time Frame: baseline, post intervention and 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Investigators

  • Principal Investigator: Terrinieka Powell, PhD, Johns Hopkins Bloomberg School of Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2022

Primary Completion (Actual)

July 31, 2023

Study Completion (Actual)

August 11, 2023

Study Registration Dates

First Submitted

July 30, 2021

First Submitted That Met QC Criteria

August 30, 2021

First Posted (Actual)

September 5, 2021

Study Record Updates

Last Update Posted (Estimated)

October 9, 2023

Last Update Submitted That Met QC Criteria

October 5, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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