Preventing Youth Substance Use With Family Talk

NCT ID: NCT04400227

Last Updated: 2022-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-31

Study Completion Date

2023-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Family Talk, an evidence-based parent-youth dyadic intervention, is a promising approach to improving substance use outcomes for high-risk families, and its structure lends itself to delivery by existing personnel within an Office-Based Addiction Treatment (OBAT) model of care. The investigators propose a single-arm pilot study with 25 parent-youth dyads through which a rapid cycle performance improvement approach will be employed to adapt and optimize the content and delivery of the embedded Family Talk prevention strategy. The investigators will field-test relevant baseline and outcome measures and will use qualitative methodology to identify key modifications to the intervention and generate hypotheses for how the prevention strategy may impact youth and family outcomes and prevent youth substance use. Information from this study will inform a subsequent pilot randomized controlled trial of the intervention to prevent substance use for youth whose parents are in recovery from SUD (substance use disorder).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Substance Use Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Youth-Parent Dyads

Participants will receive the Family Talk intervention and followup.

Group Type EXPERIMENTAL

Family Talk

Intervention Type OTHER

Family Talk is an evidence-based, parent-youth dyadic approach that uses psychoeducation and skills building to help families make meaning of a parent's adversity, increase resilience, and improve family functioning.

The Family Talk model comprises two components: the first involves a series of cognitive-behavioral techniques to bolster problem solving and communication skills among family members; the second involves a facilitated family meeting to develop a shared narrative for discussing each family member's experience of the parent's illness.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Family Talk

Family Talk is an evidence-based, parent-youth dyadic approach that uses psychoeducation and skills building to help families make meaning of a parent's adversity, increase resilience, and improve family functioning.

The Family Talk model comprises two components: the first involves a series of cognitive-behavioral techniques to bolster problem solving and communication skills among family members; the second involves a facilitated family meeting to develop a shared narrative for discussing each family member's experience of the parent's illness.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Participating parent is receiving treatment for substance use disorder
* Participating youth is between the ages of 12-25
* Participating youth has no diagnosis of substance use disorder
* Parent and youth are both comfortable communicating in English or Spanish

Exclusion Criteria

* Acute family crisis, such as recent or current incarceration, divorce, adult return to substance use, or traumatic event
* Adult or youth with cognitive limitation or intellectual disability
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Boston Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Caroline Kistin, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Scott Hadland, MD

Role: STUDY_DIRECTOR

Massachusetts General Hospital

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

K23DA045085

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-38895

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.