NCT07700849

Brief Summary

The goal of this randomized clinical trial is to learn if a brief family-based intervention in effective in reducing cannabis use and delinquency in youth participating in juvenile diversion. The main questions it aims to answer are: Hypothesis 1: the intervention will be (a) feasible, as evidenced by enrollment rates (\> 80%), follow-up rates (\> 80%), and withdrawal rates (\< 20%); and (b) acceptable, as evidenced by \> 80% of treatment evaluation ratings in the highest two Likert rating categories and positive exit interview feedback. Hypothesis 2: those parents in the experimental condition, as compared to the active comparison psychoeducation condition, will evidence greater improvement over time in the hypothesized family-level mechanisms proposed in the intervention (i.e., parenting practices and parent well-being) as well as in youth-level outcomes, including cannabis use, recidivism, and HIV/STI risk. Researchers will compare the family-based treatment to parenting psychoeducation. Caregiver and youth participants will complete measures relevant to primary outcomes and putative mechanisms at baseline, 3-month, and 6-month follow-ups.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
31mo left

Started Jul 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Jul 2026Feb 2029

First Submitted

Initial submission to the registry

July 7, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 14, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

July 15, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2029

Last Updated

July 14, 2026

Status Verified

June 1, 2026

Enrollment Period

2.6 years

First QC Date

July 7, 2026

Last Update Submit

July 7, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Timeline Follow-Back

    This youth report measure assess for past 90-day youth cannabis, alcohol, other drug use, as well as risky sexual behaviors on use days.

    The Timeline Follow-Back will be administered at baseline, 3-months, and 6-months post baseline.

  • Official arrest records

    Official arrest records will be collected as an index of recidivism among youth.

    Official arrest records will be collected for the 12 months following baseline.

  • Marijuana Adolescent Problem Inventory

    This youth-reported measure assesses for cannabis-related consequences among youth.

    We will collect this measure at baseline, 3-months, and 6-months post baseline.

Study Arms (2)

Family-based intervention

EXPERIMENTAL

The family-based intervention is proposed as 6 sessions long and will have the following modules: 1) Introduction to Treatment; 2) Parent Training Strategies (clinician must cover at least 1 topic from this module); 3) Improving Parent Well-Being (clinician must cover at least 1 topic from this module); and 4) Treatment Termination and Future Planning (see Table 1 for information regarding modules and session content). Youth will attend the first and last session, in addition to other relevant sessions (e.g., household rules/consequences); parents will attend every session.

Behavioral: Brief Family Based Intervention

Parenting Psychoeducation

ACTIVE COMPARATOR

Psychoeducation in the comparison group will involve 6 hour-long sessions delivered via secure videoconferencing focused on providing parents with key developmental knowledge regarding adolescence and parenting. To differentiate the psychoeducation provided in the intervention group, sessions will focus on typical adolescent development and parenting knowledge derived from Centers for Disease Control publicly available information. The first two sessions will provide information about typical developmental milestones in adolescence (e.g., increased need for privacy and independence). The third and fourth session will provide information on healthy vs. unhealthy behaviors in adolescence (e.g., safe driving behaviors). Finally, the final two sessions will give parents' knowledge regarding general positive parenting practices to shape healthy adolescent development. This is an active comparison condition seeking to change parents' parenting knowledge regarding typical challenges parent

Behavioral: Parenting Psychoeducation

Interventions

The intervention is proposed as 6 sessions long and will have the following modules: 1) Introduction to Treatment; 2) Parent Training Strategies (clinician must cover at least 1 topic from this module); 3) Improving Parent Well-Being (clinician must cover at least 1 topic from this module); and 4) Treatment Termination and Future Planning. Youth may attend the first and last session, in addition to other relevant sessions (e.g., household rules/consequences); parents will attend every session. Clinicians will use measures available from the baseline assessment relevant to treatment mechanisms (i.e., indices of parent well-being and parenting skills, the initial clinical interview from the first session, and the family's treatment goals to determine session content.

Family-based intervention

Psychoeducation in the comparison group will involve 6 hour-long sessions delivered via secure videoconferencing focused on providing parents with key developmental knowledge regarding adolescence and parenting. To differentiate the psychoeducation provided in the intervention group, sessions will focus on typical adolescent development and parenting knowledge derived from Centers for Disease Control publicly available information.The first two sessions will provide information about typical developmental milestones in adolescence (e.g., increased need for privacy and independence). The third and fourth session will provide information on healthy vs. unhealthy behaviors in adolescence (e.g., safe driving behaviors). Finally, the final two sessions will give parents' knowledge regarding general positive parenting practices to shape healthy adolescent development. This is an active comparison condition seeking to change parents' parenting knowledge regarding typical challenges parents

Parenting Psychoeducation

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bradley-Hasbro Children's Research Center

Providence, Rhode Island, 02903, United States

Location

Central Study Contacts

Kaitlin Sheerin, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

July 7, 2026

First Posted

July 14, 2026

Study Start

July 15, 2026

Primary Completion (Estimated)

February 28, 2029

Study Completion (Estimated)

February 28, 2029

Last Updated

July 14, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Given the doubly-protected nature of this population (i.e., children and youth with juvenile justice involvement), we will not be sharing IPD with other researchers.

Locations