search
Back to results

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

Primary Purpose

Substance Use, Sexual Behavior, Adolescent Behavior

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adapted FOY+ImPACT
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Use focused on measuring substance use prevention, adolescent health, selective intervention, community-based research, parental drug use

Eligibility Criteria

13 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

-

Sites / Locations

  • Johns Hopkins Bloomberg School of Public Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Participants who receive the FOY+ImPACT intervention

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

Outcomes

Primary Outcome Measures

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".
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".

Secondary Outcome Measures

Full Information

First Posted
July 30, 2021
Last Updated
October 5, 2023
Sponsor
Johns Hopkins Bloomberg School of Public Health
search

1. Study Identification

Unique Protocol Identification Number
NCT05033821
Brief Title
A Library-based Prevention Intervention for Adolescents Affected by Parental Drug Use
Official Title
A Library-based Prevention Intervention for Adolescents Affected by Parental Drug Use
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
July 8, 2022 (Actual)
Primary Completion Date
July 31, 2023 (Actual)
Study Completion Date
August 11, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use, Sexual Behavior, Adolescent Behavior
Keywords
substance use prevention, adolescent health, selective intervention, community-based research, parental drug use

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants who receive the FOY+ImPACT intervention
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants who receive standard library programing, but not the FOY+ImPACT intervention.
Intervention Type
Behavioral
Intervention Name(s)
Adapted FOY+ImPACT
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in youth substance use based on Youth Risk Behavior Surveillance Survey
Description
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".
Time Frame
baseline, post intervention and 3 months
Title
2. Change in youth sexual risk-taking based on Youth Risk Behavior Surveillance Survey
Description
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".
Time Frame
baseline, post intervention and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Black/African American 13-16 years old have a caregiver with a history of drug use English-speaking Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terrinieka Powell, PhD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bloomberg School of Public Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We do not plan to make individual participant data available to other researchers.
Citations:
PubMed Identifier
33937999
Citation
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.
Results Reference
background
PubMed Identifier
32606485
Citation
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.
Results Reference
background
PubMed Identifier
34118586
Citation
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.
Results Reference
background
Links:
URL
http://www.researchbypowell.com
Description
Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs