Adolescents With Substance Use Disorders Transitioníng From Residential Treatment to the Community

NCT03592186 | Completed Results DMC

• 2 other identifiers: 1802001981R34DA039289
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 2

Brief Summary

Adolescents with substance use disorders (ASUD) in residential treatment have the most serious substance use disorders and the highest rates of psychological, motivational, behavioral, legal, environmental, and vocational problems. ASUD in residential treatment are also at high risk of relapse, with follow-up studies suggesting that 60% of ASUD will relapse within 90 days of discharge. Parenting practices have been established as a key influence on adolescents' initiation and maintenance of substance use, as well as their substance use outcomes and likelihood of relapse. However, therapists who treat ASUD have reported a myriad of systemic barriers to engaging parents in treatment. Findings such as these deem ASUD in residential treatment a high priority population and argue for the value of easily accessible parenting interventions during this critical time. The proposed study evaluates a low cost, low intensity model for delivering parenting skills to parents preparing for their adolescent's discharge from residential substance use (SU) treatment. Specifically, this project involves adapting the delivery of a computerized parenting intervention (Parenting Wisely; PW) that has preliminary evidence of efficacy in improving parenting skills and reducing youth behavior problems. This study adapts the delivery of PW for a new population (parents of ASUD) and new setting (residential treatment), and obtains initial data on its feasibility, acceptability, and effectiveness. As a first step, an open trial with 10 parents was conducted to develop and pilot an adapted version of PW that included moderate engagement strategies: in-person coaching sessions, daily text messages containing reminders of parenting skills and links to video vignettes, and an online parent forum containing two networking boards (Ask an Expert and Connect with Parents). In the current phase, a pilot randomized trial with 60 parents will compare an adapted PW plus treatment as usual (TAU) condition (PW+) versus TAU only in a residential treatment center. Both treatment conditions will be delivered by Bachelor's or Master's-level community clinicians. This small trial will provide some initial evidence regarding the utility of a low-cost, low-intensity intervention and whether a larger, fully powered trial is indicated in the future.

Conditions

Substance Use; Adolescent Behavior

Keywords

adolescent; substance use

Outcome Measures

Primary Outcomes (1)

• Change in Proportion of Days Used Outside of Controlled Environment

  Global Appraisal of Individual Needs - Quick Version (GAIN-Q3) is a well-validated substance use screening tool 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 proportion of days used outside of controlled environment, with final values ranging from 0 to 1.0; a higher number indicates a higher proportion of days used.

  Change from baseline to 24-week post-discharge

Secondary Outcomes (2)

• Change in Global Appraisal of Individual Needs - Quick Version (GAIN-Q3) Substance-Related Problems Scale

  Change in substance-related problems from baseline to the 24-week post-discharge assessment

• Count of Adolescents Testing Negative on Urine Screens

  12 weeks

Study Arms (2)

Parenting Wisely+

EXPERIMENTAL

Parenting Wisely+ consists of access to the Parenting Wisely computer program (www.parentingwisely.com), paired with engagement strategies: up to four in-person coaching sessions, daily text messages, and access to an online networking forum.

Behavioral: Parenting Wisely+; Behavioral: Treatment as Usual

Treatment as Usual

ACTIVE COMPARATOR

The active comparator is defined as residential treatment services as usual. At short-term facility, average length of stay was 6-10 days. At long-term facility, average length of stay was 30-45 days.

Behavioral: Treatment as Usual

Interventions

Parenting Wisely+ BEHAVIORAL

Parenting Wisely+ experimental intervention

Also known as: Parenting Wisely, PW

Parenting Wisely+

Treatment as Usual BEHAVIORAL

Treatment as Usual

Parenting Wisely+; Treatment as Usual

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age 12 years -17 years inclusive
• admitted to residential treatment due to problems related to substance use
• ability to complete study assessments in English or Spanish
• ability to understand and willingness to provide written assent

You may not qualify if:

• \-- Conditions that preclude participation in a 2-3 hour interview (e.g., mania, psychosis, intoxication, cognitive impairment)
• primary custodial guardian of the adolescent after discharge from residential
• access to the internet in the home or workplace to view intervention content, as well as access to a phone that can receive text messages
• ability to complete study sessions and assessments in English or Spanish (and must complete the first baseline assessment prior to teen's discharge from residential)
• ability to understand and willingness to provide written consent
• \-- Conditions that preclude participation in a 1-2 hour interview (e.g., mania, psychosis, intoxication, cognitive impairment)

Sponsors & Collaborators

• Brown University: lead
• Rhode Island Hospital: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Rosecrance Health Network

Rockford, Illinois, 61107, United States

Location

Caritas ARTS Program

Cranston, Rhode Island, 02920, United States

Location

Related Publications (1)

• Becker SJ, Helseth SA, Janssen T, Kelly LM, Escobar KI, Souza T, Wright T, Spirito A. Parent SMART (Substance Misuse in Adolescents in Residential Treatment): Pilot randomized trial of a technology-assisted parenting intervention. J Subst Abuse Treat. 2021 Aug;127:108457. doi: 10.1016/j.jsat.2021.108457. Epub 2021 Apr 30.

  PMID: 34134877 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders; Adolescent Behavior

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavior

Limitations and Caveats

Small pilot trial designed to inform the design of a fully powered trial. The pre-specified analytical plan used mixed models: hence, the outcome values reported here (means, standard deviations) will not align with the primary outcome analysis.

Results Point of Contact

• Title: Sara Becker, Ph.D, Principal Investigator
• Organization: Brown University School of Public Health

sara_becker@brown.edu

4018636604

Study Officials

• Sara J Becker, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2018
• First Posted: July 19, 2018
• Study Start: April 1, 2017
• Primary Completion: August 30, 2019
• Study Completion: February 28, 2020
• Last Updated: January 21, 2022
• Results First Posted: December 11, 2020

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Within 6 months of study completion for next 7 years
• Access Criteria: Contact the Study PI

Locations

US (2)