Clinical trial NCT04400227: Preventing Youth Substance Use With Family Talk
Official title: Pilot Study of Family Talk to Prevent Youth Substance Use
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Substance Use Disorders
Keywords: parent-youth dyads
modules
prevention of adolescent SUD (substance use disorder)
Family Talk
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-05-22
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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).


Eligibility criteria: 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

Primary outcomes:
measure: Change in youth substance use based on the Timeline Followback Interview
timeFrame: baseline, 6 months
measure: Youth substance use based on the Timeline Followback Interview at 2 months
timeFrame: 2 months
measure: Youth substance use based on the Timeline Followback Interview at 4 months
timeFrame: 4 months
measure: Change in Youth substance use based on the Screening to Brief Intervention Tool
timeFrame: baseline, 6 months
measure: Youth substance use based on the Screening to Brief Intervention Tool at 2 months
timeFrame: 2 months
measure: Youth substance use based on the Screening to Brief Intervention Tool at 4 months
timeFrame: 4 months
Secondary outcomes:
measure: Family Functioning based on the Family Problem Solving Communication Index
timeFrame: baseline, 2, 4, 6 months
measure: Family Functioning based on the Inventory of Parent and Peer Attachment
timeFrame: baseline, 2, 4, 6 months
measure: Depression
timeFrame: baseline, 2, 4, 6 months
measure: Perceived Stress
timeFrame: baseline, 2, 4, 6 months
measure: Problem Solving
timeFrame: baseline, 2, 4, 6 months
measure: Coping based on the Coping Self-Efficacy Scale
timeFrame: baseline, 2, 4, 6 months
measure: Coping based on the Brief COPE
timeFrame: baseline, 2, 4, 6 months
measure: Social support
timeFrame: baseline, 2, 4, 6 months
measure: Stressful Life Events
timeFrame: baseline, 2, 4, 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Boston Medical Center
name: Caroline Kistin, MD MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Scott Hadland, MD
role: STUDY_DIRECTOR
References: