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

Adolescent Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05033821
• Other study ID #: K01
• Status: Completed
• Phase: N/A
• Start date: July 8, 2022
• Est. completion date: August 11, 2023

Study information

• Verified date: October 2023
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: August 11, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 16 Years

Eligibility

Inclusion Criteria:

• Black/African American

• 13-16 years old

• have a caregiver with a history of drug use

• English-speaking

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Adolescent Behavior
• Sexual Behavior
• Substance Use
• Substance-Related Disorders

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).

Locations

Country	Name	City	State
United States	Johns Hopkins Bloomberg School of Public Health	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

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