Parent SMART (Substance Misuse in Adolescents in Residential Treatment)
Primary Purpose
Substance Use, Adolescent Behavior
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parent SMART
Treatment as Usual
Sponsored by
About this trial
This is an interventional treatment trial for Substance Use focused on measuring adolescent, substance use, substance-related disorders
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
Sites / Locations
- Rosecrance Health Network
- Rosecrance Jackson CentersRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Parent SMART
Treatment as Usual
Arm Description
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.
The active comparator is defined as residential treatment services as usual.
Outcomes
Primary Outcome Measures
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.
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.
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.
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%.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05169385
First Posted
December 13, 2021
Last Updated
July 31, 2023
Sponsor
Brown University
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT05169385
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
February 2, 2027 (Anticipated)
Study Completion Date
February 2, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brown University
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use, Adolescent Behavior
Keywords
adolescent, substance use, substance-related disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Effectiveness Trial
Masking
Outcomes Assessor
Masking Description
Outcomes assessors will be masked to study condition.
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Parent SMART
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
The active comparator is defined as residential treatment services as usual.
Intervention Type
Behavioral
Intervention Name(s)
Parent SMART
Intervention Description
Parent SMART experimental intervention
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Intervention Description
Residential treatment as usual
Primary Outcome Measure Information:
Title
Change in Parental Monitoring
Description
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.
Time Frame
Baseline to 24 Weeks Post Discharge
Title
Change in Parental Communication
Description
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.
Time Frame
Baseline to 24 Weeks Post Discharge
Title
Change in Family Assessment Task Interaction Ratings
Description
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.
Time Frame
Baseline to 24 Weeks Post Discharge
Title
Change in Proportion of Days Used Over the Past 90 Days Outside of a Controlled Environment
Description
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%.
Time Frame
Baseline to 24 Weeks Post Discharge
Title
Change in Substance Use Problems
Description
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.
Time Frame
Baseline to 24 Weeks Post Discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara J Becker, Ph.D.
Phone
(401) 863-6604
Email
sara_becker@brown.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Helseth, Ph.D.
Phone
(401) 863-6881
Email
sarah_helseth@brown.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Becker
Organizational Affiliation
Brown University School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rosecrance Health Network
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61107
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Wright, MD
Facility Name
Rosecrance Jackson Centers
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Wright
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing 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.
Citations:
PubMed Identifier
35225821
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.
Results Reference
derived
Learn more about this trial
Parent SMART (Substance Misuse in Adolescents in Residential Treatment)
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