NCT05169385

Brief Summary

Adolescents in residential substance use treatment have serious substance-related problems and poor outcomes following discharge: follow-up studies indicate that 60% of adolescents treated in residential treatment will relapse within the first 90 days. Parenting practices have been established as a critical predictor of adolescents' substance use outcomes and likelihood of relapse following treatments, but parents are notoriously difficult to engage in adolescent substance use treatment. Findings such as these provide strong justification for targeting parents of adolescents in residential substance use treatment via easily accessible interventions. This study tests the effectiveness of a technology-assisted parenting intervention called Parent SMART (Substance Misuse among Adolescents in Residential Treatment). The intervention combines an off-the-shelf computer program that teaches parenting skills called Parenting Wisely, four telehealth coaching sessions, and a networking forum that allows parents to connect with a clinical expert and with other parents. The investigators will compare adolescents who receive standard residential substance use treatment to adolescents who receive the same treatment plus whose parents receive Parent SMART. Investigators will test the comparative effectiveness of Parent SMART versus residential treatment as usual on parental monitoring and communication, adolescent substance use (i.e., days of substance use and substance-related problems), and substance-related high-risk behaviors (i.e., school-related problems, criminal involvement, externalizing behavior). The investigators will also test whether improvements in parenting partially mediate any observed changes in adolescent substance use and other high-risk behaviors.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

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 Progress86%
Mar 2022Feb 2027

First Submitted

Initial submission to the registry

December 13, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 27, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2027

Last Updated

April 3, 2025

Status Verified

April 1, 2025

Enrollment Period

4.9 years

First QC Date

December 13, 2021

Last Update Submit

April 1, 2025

Conditions

Keywords

adolescentsubstance usesubstance-related disorders

Outcome Measures

Primary Outcomes (5)

  • Change in Parental Monitoring

    The Parental Monitoring Questionnaire (PMQ), a parent-report and adolescent-report measure, will be used to assess dimensions of parental monitoring. It has three subscales: Child Disclosure, Parent Solicitation, and Parental Control.

    Baseline to 24 Weeks Post Discharge

  • Change in Parental Communication

    The Parent-Adolescent Communication Scale (PCAS), a parent-report and adolescent-report measure, will be used to assess dimensions of parental monitoring. It has two subscales: General Communication and Problems with Communication.

    Baseline to 24 Weeks Post Discharge

  • Change in Family Assessment Task Interaction Ratings

    The Family Assessment Task, a video-taped family problem solving task will be used to provide an in vivo assessment of parenting behavior. Three tasks provide data on monitoring and communication: Limit Setting, Substance Use Norms, and Monitoring and Listening. Tapes will be coded by two raters blind to condition.

    Baseline to 24 Weeks Post Discharge

  • Change in Proportion of Days Used Over the Past 90 Days Outside of a Controlled Environment

    The Global Appraisal of Individual Needs - Core is a well-validated clinical interview used to assess adolescent substance use in a range of settings. Substance consumption information is collected using a calendar format with temporal cues (e.g., holidays) to assist in recall of days when alcohol and other drugs were used. Possible number of days range from 0 to 90. Values are adjusted to reflect the percent of days used outside of controlled environment, with final values ranging from 0 to 100%.

    Baseline to 24 Weeks Post Discharge

  • Change in Substance Use Problems

    The Global Appraisal of Individual Needs - Core is a well-validated clinical interview used to assess adolescent substance use in a range of settings. The Substance-Related Problems Scale provides a count of substance-related problems experienced over the past 90 days. Possible values range from 0 to 11.

    Baseline to 24 Weeks Post Discharge

Study Arms (2)

Parent SMART

EXPERIMENTAL

Parent SMART is a technology-assisted parenting intervention combining an off-the-shelf computer program (Parenting Wisely), up to four telehealth coaching sessions, and access to an app-based networking forum.

Behavioral: Parent SMART

Treatment as Usual

ACTIVE COMPARATOR

The active comparator is defined as residential treatment services as usual.

Behavioral: Treatment as Usual

Interventions

Parent SMARTBEHAVIORAL

Parent SMART experimental intervention

Parent SMART

Residential treatment as usual

Treatment as Usual

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • admitted to residential treatment due to concerns about frequency and/or severity of substance use
  • report alcohol and/or drug use in the past 90 days
  • be discharged to live with primary guardian
  • fluent in English or Spanish
  • willing and able to participate in a 2 hour interview prior to discharge from residential

You may not qualify if:

  • does not report alcohol or drug use in the past 90 days
  • discharge plan does not include living with primary guardian
  • not fluent in English or Spanish
  • not willing or able to complete baseline interview
  • parent or legal guardian of adolescent aged 12-18 years inclusive, at project start
  • adolescent admitted to residential treatment due to concerns about frequency and/or severity of substance use
  • will be primary guardian living with adolescent after discharge from residential
  • fluent in English or Spanish
  • willing and able to complete the baseline assessment prior to the adolescent's discharge
  • access to a smartphone that can receive text messages and reliably access the internet
  • not legal guardian of adolescent or adolescent not aged between 12-18 years
  • adolescent not admitted to residential treatment due to substance use concerns
  • will not be living with adolescent after adolescent's discharge from residential
  • not fluent in English or Spanish
  • not willing or able to complete the baseline assessment prior to the adolescent's discharge
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Rosecrance Health Network

Rockford, Illinois, 61107, United States

RECRUITING

Rosecrance Jackson Centers

Sioux City, Iowa, 51101, United States

COMPLETED

Hazelden Betty Ford

Plymouth, Minnesota, 55441, United States

RECRUITING

Related Publications (2)

  • Patel-Syed Z, Helseth SA, Rosales R, Janssen T, Scott K, Becker SJ. The effects of neighborhood perceptions on response to a technology-assisted parenting intervention for adolescent substance use: protocol of a diversity supplement to parent SMART (Substance Misuse in Adolescents in Residential Treatment). Addict Sci Clin Pract. 2024 Oct 18;19(1):75. doi: 10.1186/s13722-024-00509-y.

  • Becker SJ, Helseth SA, Kelly LM, Janssen T, Wolff JC, Spirito A, Wright T. Parent SMART (Substance Misuse in Adolescents in Residential Treatment): Protocol of a Randomized Effectiveness Trial of a Technology-Assisted Parenting Intervention. JMIR Res Protoc. 2022 Feb 28;11(2):e35934. doi: 10.2196/35934.

MeSH Terms

Conditions

Substance-Related DisordersAdolescent Behavior

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersBehavior

Study Officials

  • Sara J Becker, Ph.D.

    Brown University and Northwestern University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes assessors will be masked to study condition.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Effectiveness Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2021

First Posted

December 27, 2021

Study Start

March 1, 2022

Primary Completion (Estimated)

February 2, 2027

Study Completion (Estimated)

February 2, 2027

Last Updated

April 3, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

Study protocol and statistical analysis plan for the primary outcomes will be submitted to the Journal of Medical Internet Research Protocols. Additional data (analytic code, participant-level data) can be requested from the Principal Investigator. Analysis files will be constructed from the stored electronic data and will be stripped of identifying information. Specifically, participants will be identified with a numeric identifier that is not related to any element of their personal identifying information. No names, addresses, telephone numbers, fax numbers, email addresses, medical record numbers, etc. will be retained in the de-identified files.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Protocol will be submitted for publication in 2021. Analytic code and participant-level data will be made ready for distribution within 12 months of study completion.
Access Criteria
Data will only be shared with external investigators when a data use agreement (DUA) is executed between Brown University and the requester's institution. The DUA will specify the requested data elements (each of which must be justified), the specific research question, the timeline for the project, and schedule for data destruction.

Locations