Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05169385
Other study ID # 2006002748
Secondary ID R37DA052918
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2022
Est. completion date February 2, 2027

Study information

Verified date March 2024
Source Brown University
Contact Sara J Becker, Ph.D.
Phone (401) 863-6604
Email sara_becker@brown.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 220
Est. completion date February 2, 2027
Est. primary completion date February 2, 2027
Accepts healthy volunteers No
Gender All
Age group 12 Years to 18 Years
Eligibility 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

Study Design


Intervention

Behavioral:
Parent SMART
Parent SMART experimental intervention
Treatment as Usual
Residential treatment as usual

Locations

Country Name City State
United States Rosecrance Health Network Rockford Illinois
United States Rosecrance Jackson Centers Sioux City Iowa

Sponsors (2)

Lead Sponsor Collaborator
Brown University National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05806840 - Rapid Adaptation to Prevent Drug Use N/A
Recruiting NCT06003725 - Cultural Adaptation of Drug Treatment for DJJ Youth N/A
Recruiting NCT05414344 - A Brief Intervention for Alcohol Users With Interpersonal Trauma N/A
Recruiting NCT05768815 - Optimizing Mental Health for Infants Exposed to Early Adversity: A Comparison of Breaking the Cycle and Maxxine Wright N/A
Completed NCT05606601 - An Online Intervention Addressing Mental Health and Substance Use in University Students N/A
Completed NCT03489434 - Technology-Based Prevention for Adolescents in Primary Care N/A
Completed NCT04284813 - Families With Substance Use and Psychosis: A Pilot Study N/A
Recruiting NCT05899101 - The Impact of Opioid and Cannabis Exposure on Fetal Growth
Completed NCT02990026 - Specialty Mental Health Probation in North Carolina N/A
Not yet recruiting NCT06116266 - Collaborative Care for Polysubstance Use in Primary Care Settings (Co-Care) N/A
Not yet recruiting NCT03249428 - E-Cigarette Inner City RCT N/A
Active, not recruiting NCT03129334 - Preventing Prescription Drug Abuse in Middle School Students N/A
Completed NCT04183400 - Safety Awareness For Empowerment (SAFE): An RCT With Young People Experiencing Homelessness N/A
Completed NCT02112201 - The ProGirls Study N/A
Completed NCT01752998 - Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings N/A
Terminated NCT01661517 - Brief Intervention and Referral to Treatment With Substance Use Disorders in the Emergency Room Setting Phase 0
Completed NCT01351454 - Behavioral Depression Treatment for African American HIV-infected Substance Users N/A
Completed NCT01511380 - Targeting HIV Risk Behaviors in Juvenile Drug Court-Involved Youth Phase 2
Completed NCT01154309 - Group CBT for Depression and AOD Disorders Phase 1
Completed NCT00996541 - Support To Reunite Involve and Value Each Other N/A