Preventing Youth Substance Use With Family Talk

NCT04400227 | Withdrawn

• 2 other identifiers: H-38895K23DA045085
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Substance Use Disorders

Keywords

parent-youth dyads; modules; prevention of adolescent SUD (substance use disorder); Family Talk

Outcome Measures

Primary Outcomes (6)

• Change in youth substance use based on the Timeline Followback Interview

  The Timeline Followback Interview (TLFB) will be used to estimate substance use. It uses a calendar and asks the participant to indicate whether they used substances on each of the days listed for the last 3 months. No score is given for the measure. However, more days of use is associated with adverse health outcomes.

  baseline, 6 months

• Youth substance use based on the Timeline Followback Interview at 2 months

  The Timeline Followback Interview (TLFB) will be used to estimate substance use. It uses a calendar and asks the participant to indicate whether they used substances on each of the days listed for the last 3 months. No score is given for the measure. However, more days of use is associated with adverse health outcomes.

  2 months

• Youth substance use based on the Timeline Followback Interview at 4 months

  The Timeline Followback Interview (TLFB) will be used to estimate substance use. It uses a calendar and asks the participant to indicate whether they used substances on each of the days listed for the last 3 months. No score is given for the measure. However, more days of use is associated with adverse health outcomes.

  4 months

• Change in Youth substance use based on the Screening to Brief Intervention Tool

  The Screening to Brief Intervention instrument, or S2BI, is a 7-item instrument that asks about tobacco, alcohol, marijuana, prescribed drugs, inhalants, illegal drugs, and herbs/synthetic drugs. Responses for each substance can be 'never', 'once or twice', 'monthly', of 'weekly or more'. The result range from "no reported use," "lower risk," or "higher risk." For the lower and higher risk categories the intervention provides guidance for developing an action plan for each response category.

  baseline, 6 months

• Youth substance use based on the Screening to Brief Intervention Tool at 2 months

  The Screening to Brief Intervention instrument, or S2BI, is a 7-item instrument that asks about tobacco, alcohol, marijuana, prescribed drugs, inhalants, illegal drugs, and herbs/synthetic drugs. Responses for each substance can be 'never', 'once or twice', 'monthly', of 'weekly or more'. The result range from "no reported use," "lower risk," or "higher risk." For the lower and higher risk categories the intervention provides guidance for developing an action plan for each response category.

  2 months

• Youth substance use based on the Screening to Brief Intervention Tool at 4 months

  The Screening to Brief Intervention instrument, or S2BI, is a 7-item instrument that asks about tobacco, alcohol, marijuana, prescribed drugs, inhalants, illegal drugs, and herbs/synthetic drugs. Responses for each substance can be 'never', 'once or twice', 'monthly', of 'weekly or more'. The result range from "no reported use," "lower risk," or "higher risk." For the lower and higher risk categories the intervention provides guidance for developing an action plan for each response category.

  4 months

Secondary Outcomes (9)

• Family Functioning based on the Family Problem Solving Communication Index

  baseline, 2, 4, 6 months

• Family Functioning based on the Inventory of Parent and Peer Attachment

  baseline, 2, 4, 6 months

• Depression

  baseline, 2, 4, 6 months

• Perceived Stress

  baseline, 2, 4, 6 months

• Problem Solving

  baseline, 2, 4, 6 months

Study Arms (1)

Youth-Parent Dyads

EXPERIMENTAL

Participants will receive the Family Talk intervention and followup.

Other: Family Talk

Interventions

Family Talk 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.

Youth-Parent Dyads

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead
• National Institute on Drug Abuse (NIDA): collaborator

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Caroline Kistin, MD MSc

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

• Scott Hadland, MD

  Massachusetts General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 22, 2020
• Study Start: July 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: July 13, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share