Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05033821
Other study ID # K01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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: -

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT05071989 - The Influence of Sleep Education With Social Media Reminders on the Sleep Quality in Adolescents N/A
Recruiting NCT05064293 - Assisted Identification and Navigation of Early Mental Health Symptoms in Children N/A
Enrolling by invitation NCT05017779 - A Hybrid Effectiveness-implementation Trial of a High School-based Executive Function Treatment for Autistic Youth N/A
Completed NCT03685643 - Study Proposal for Web Based Intervention to Promote the Safe Usage of Dating Applications in Young Adults N/A
Completed NCT03270943 - The S.M.A.R.T. Project: Stress Management and Resilience Training for Teens N/A
Recruiting NCT05525962 - Vulnerability/Resilience Factors Influencing the Developmental Trajectories and Adaptive Methods of Children and Adolescents in Child Welfare System.
Completed NCT03411577 - Development and Testing of a Jamaican Mother-daughter HIV Risk-reduction Program N/A
Recruiting NCT05334381 - Navigating Mental Health Treatment for Black Youth N/A
Active, not recruiting NCT05926141 - Advanced Cooking Education Pilot Study N/A
Recruiting NCT04317547 - Translation Study of a Safe Teen Driving Intervention N/A
Recruiting NCT06001892 - Tennessee Youth Prepared for Success N/A
Enrolling by invitation NCT06127277 - Next4You: A Fully Mobile Relationships Based Program for Youth in Foster Care N/A
Not yet recruiting NCT06310434 - Analysis of COMPASsion and Humanisation of Adolescents Facing the End-of-life Processes.
Not yet recruiting NCT05316948 - Mental Health and Sexuality in Adolescents and Young Adults
Completed NCT02683811 - Effectiveness of the Updated Version of the School-based Program Diario Della Salute (DDS-2) N/A
Terminated NCT02578147 - JUEGA: A Fun Study for Hispanic/Latino Adolescent Girls N/A
Active, not recruiting NCT02329015 - Curriculum Evaluation of a Novel Health and Wellness Program Within New York City Schools Phase 1
Completed NCT03482687 - It's Your Game: An Innovative Approach to Preventing Teen Dating Violence N/A
Completed NCT01433679 - The Effect of a Web-Based Behavioral Intervention on Physical Activity Levels in Adolescents N/A
Completed NCT00056953 - Peer Mentors for Adolescents in HIV Affected Families Phase 2

External Links