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

Sponsor
Johns Hopkins Bloomberg School of Public Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT05033821
Collaborator
(none)
120
1
2
20.5
5.9

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Adapted FOY+ImPACT
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Library-based Prevention Intervention for Adolescents Affected by Parental Drug Use
Actual Study Start Date :
Jan 14, 2022
Anticipated Primary Completion Date :
Mar 31, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in youth substance use based on Youth Risk Behavior Surveillance Survey [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".

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 16 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Black/African American

  • 13-16 years old

  • have a caregiver with a history of drug use

  • English-speaking

Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Johns Hopkins Bloomberg School of Public Health Baltimore Maryland United States 21212

Sponsors and Collaborators

  • Johns Hopkins Bloomberg School of Public Health

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT05033821
Other Study ID Numbers:
  • K01
First Posted:
Sep 5, 2021
Last Update Posted:
Apr 7, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Johns Hopkins Bloomberg School of Public Health
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 7, 2022