NCT06594835

Brief Summary

Better Together (BT) is a novel, culturally relevant library-based intervention designed to prevent substance use among Black youth (ages 11-13) affected by household challenges (i.e., parental substance use, parental incarceration, and parental mental health challenges). In partnership with public and school librarians, the investigators will conduct a randomized pilot study of BT with up to 100 youth across four sites in Baltimore, Maryland to assess:

  1. 1.Implementation fidelity via logs, assessments, and observations of participants and facilitators
  2. 2.Feasibility of all key research aspects, including recruitment, randomization, intervention, and control conditions, as well as pre, post, and one-month follow-up assessments
  3. 3.Initial effects of BT on substance use

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

8 months

First QC Date

September 3, 2024

Last Update Submit

September 12, 2024

Conditions

Keywords

substance usefeasibilityadolescents

Outcome Measures

Primary Outcomes (1)

  • Number of Youth Retained in the intervention

    Retention was evaluated in two ways. First, investigators assessed retention by the number of sessions the participant attended (dosage). Investigators defined dosage success as youth participating in five or more sessions. Second, retention was assessed by the proportion of youth who completed the post-test and 1-month follow-up. Investigators defined retention success as more than 80% of the sample was retained at all assessments.

    From enrollment to the completion of the one-month follow-up assessment

Secondary Outcomes (2)

  • Number of Youth who use any substance

    From baseline to one-month follow-up

  • Substance use knowledge as assessed by survey

    From baseline to one-month follow up

Study Arms (2)

Better Together

EXPERIMENTAL

Better Together (BT) is a 90-min, an age-appropriate, culturally relevant prevention intervention to prevent substance use among Black youth experiencing household challenges (ages 11-13) by addressing the multilevel influences of substance use.

Behavioral: Better Together

Control

ACTIVE COMPARATOR

Control group participants received a media education program

Behavioral: Youth In the Media (YM)

Interventions

Better TogetherBEHAVIORAL

Better Together (BT) is a 90-min, age-appropriate, culturally relevant prevention intervention to prevent substance use among Black youth experiencing household challenges (ages 11-13) by addressing the multilevel influences of substance use.

Better Together

Delivered in eight in-person, 90-minute sessions concurrently with BT sessions, the YM program was designed to (1) increase participants' awareness of and access to the different types of media and free resources available at the participants local libraries, (2) discuss different types of media that center stories and experiences of Black youth, and (3) expose participants to careers in media.

Control

Eligibility Criteria

Age11 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • To be eligible, participants had to be between 11 and 13 years old,
  • identify as Black or African American,
  • have been exposed to one or more household challenges (i.e., parental substance use, incarceration or mental illness)

You may not qualify if:

  • Youth in foster care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

  • Powell TW, Offiong A, Lewis Q, Prioleau M, Smith B, Johnson RM. "I've smoked weed with my daughter": Cannabis Use within Families Affected by Parental Opioid Misuse. Child Youth Serv Rev. 2023 Dec;155:107235. doi: 10.1016/j.childyouth.2023.107235. Epub 2023 Oct 15.

    PMID: 37982095BACKGROUND

Related Links

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Terrinieka Powell, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2024

First Posted

September 19, 2024

Study Start

September 1, 2023

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations