Clinical trial NCT05169385: Parent SMART (Substance Misuse in Adolescents in Residential Treatment)
Official title: Improving Outcomes of Adolescents in Residential Substance Use Treatment Via a Technology-Assisted Parenting Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Substance Use
Adolescent Behavior
Keywords: adolescent
substance use
substance-related disorders
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Northwestern University
First posted: 2021-12-27
Enrollment: 220
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Effectiveness Trial
Primary purpose: TREATMENT

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.

Detailed description: Building upon a successful National Institute on Drug Abuse (NIDA)-funded R34, this study evaluates a technology-assisted parenting intervention with evidence of high feasibility and acceptability, as well as preliminary evidence of effectiveness as an adjunct to residential treatment as usual (TAU). Specifically, this study involves a fully powered evaluation of Parent SMART (Substance Misuse among Adolescents in Residential Treatment), which was developed based on extensive formative research with parents, adolescents, and residential treatment staff, and subsequently tested in a NIDA-funded pilot trial.

Parent SMART was intentionally designed with scalability in mind. It consists of an off-the-shelf computer program called Parenting Wisely (PW) that has robust evidence of efficacy in improving parenting skills and reducing youth behavior problems across five clinical trials. Guided by formative research, Parent SMART augments PW with four telehealth coaching sessions and access to a state-of-the-art, mobile networking forum (available via both mobile phone app and web browser), where parents can submit questions to an expert and connect with other parents of adolescents in residential substance use treatment. Parent SMART was piloted at both short (i.e., 6-10 day length of stay) - and long-term (i.e., 30-45 day length of stay) residential facilities: the model was feasible and acceptable in both settings, and effective at improving parental monitoring and communication in both settings. In the short-term setting, Parent SMART was also effective at reducing days of substance use (i.e., days of binge drinking, days of all other drug use) and reducing school problems: the pilot project was underpowered to detect differences at the long-term setting. The current trial is a fully powered evaluation of Parent SMART as an adjunct to residential treatment as usual.

Adolescent-parent dyads (n = 220; 440 participants) will be randomized to receive either residential treatment as usual (TAU) only or Parent SMART + TAU. Those randomized to TAU will be offered the technology-delivered elements of Parent SMART at the 6-month follow-up. Parent SMART telehealth sessions will be delivered by bachelor's and master's level counselors to enhance scalability. Multi-method follow-up assessments (i.e., self-report measures, videotaped interaction task, urine screens) will be conducted 6-, 12-, and 24-weeks post-discharge.

The primary aims of this study is to examine the effectiveness of Parent SMART as an adjunctive treatment, relative to adolescent residential treatment-as-usual on: parenting processes (Primary Aim 1) and adolescent substance use outcomes (Primary Aim 2). A secondary aim is to test the effectiveness of Parent SMART compared to residential treatment-as-usual on adolescent high-risk behaviors. An additional Exploratory Aim will test whether change in parenting processes mediates change in adolescent substance use outcomes.

Pursuit of these aims is significant given the potential to improve the outcomes of adolescents following discharge from residential substance use treatment by offering their parents a novel technology-assisted intervention. Technology-assisted interventions have the potential for marked public health impact by extending the reach, duration, and scalability of evidence-based care.

Eligibility criteria: Inclusion Criteria for Adolescents:

* 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

Exclusion Criteria for Adolescents:

* 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

Inclusion Criteria for Parents:

* 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

Exclusion Criteria for Parents:

* 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
* does not have access to a smartphone that can receive text messages and reliably access the internet

Primary outcomes:
measure: Change in Parental Monitoring
timeFrame: Baseline to 24 Weeks Post Discharge
measure: Change in Parental Communication
timeFrame: Baseline to 24 Weeks Post Discharge
measure: Change in Family Assessment Task Interaction Ratings
timeFrame: Baseline to 24 Weeks Post Discharge
measure: Change in Proportion of Days Used Over the Past 90 Days Outside of a Controlled Environment
timeFrame: Baseline to 24 Weeks Post Discharge
measure: Change in Substance Use Problems
timeFrame: Baseline to 24 Weeks Post Discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Rockford
country: United States
facility: Rosecrance Health Network
state: Illinois
city: Sioux City
country: United States
facility: Rosecrance Jackson Centers
state: Iowa
city: Plymouth
country: United States
facility: Hazelden Betty Ford
state: Minnesota
Study officials:
affiliation: Brown University and Northwestern University
name: Sara J Becker, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.