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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03592186
Recruitment Status : Completed
First Posted : July 19, 2018
Results First Posted : December 11, 2020
Last Update Posted : January 21, 2022
Sponsor:
Collaborators:
Rhode Island Hospital
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Brown University

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.

Condition or disease Intervention/treatment Phase
Substance Use Adolescent Behavior Behavioral: Parenting Wisely+ Behavioral: Treatment as Usual Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adolescents With Substance Use Disorders Transitioning From Residential Treatment to the Community: Improving Outcomes Via a Computer Assisted Parenting Program
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : August 30, 2019
Actual Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Parenting

Arm Intervention/treatment
Experimental: Parenting Wisely+
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+
Parenting Wisely+ experimental intervention
Other Names:
  • Parenting Wisely
  • PW

Behavioral: Treatment as Usual
Treatment as Usual

Active Comparator: Treatment as Usual

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
Treatment as Usual




Primary Outcome Measures :
  1. Change in Proportion of Days Used Outside of Controlled Environment [ Time Frame: Change from baseline to 24-week post-discharge ]
    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.


Secondary Outcome Measures :
  1. Change in Global Appraisal of Individual Needs - Quick Version (GAIN-Q3) Substance-Related Problems Scale [ Time Frame: Change in substance-related problems from baseline to the 24-week post-discharge assessment ]
    The GAIN-Q3 is a well-validated substance use screening tool 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, with higher scores indicating a greater number of substance-related problems.

  2. Count of Adolescents Testing Negative on Urine Screens [ Time Frame: 12 weeks ]
    8 panel urine drug screens testing for marijuana, ecstasy/molly, cocaine, amphetamines, methamphetamines, opiates, oxycodone, and benzodiazepines. Urine screen results will be coded as positive or negative for any substance, and a count of adolescents obtaining a negative urine screen in each condition will be obtained.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for Adolescents:

  • 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

Exclusion Criteria for Adolescents:

-- Conditions that preclude participation in a 2-3 hour interview (e.g., mania, psychosis, intoxication, cognitive impairment)

Inclusion Criteria for Parents:

  • legal guardian of adolescent meeting the adolescent inclusion criteria
  • 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

Exclusion Criteria for Parents:

-- Conditions that preclude participation in a 1-2 hour interview (e.g., mania, psychosis, intoxication, cognitive impairment)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03592186


Locations
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United States, Illinois
Rosecrance Health Network
Rockford, Illinois, United States, 61107
United States, Rhode Island
Caritas ARTS Program
Cranston, Rhode Island, United States, 02920
Sponsors and Collaborators
Brown University
Rhode Island Hospital
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Sara J Becker, PhD Brown University
  Study Documents (Full-Text)

Documents provided by Brown University:
Informed Consent Form  [PDF] October 3, 2018

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Brown University
ClinicalTrials.gov Identifier: NCT03592186    
Other Study ID Numbers: 1802001981
R34DA039289 ( U.S. NIH Grant/Contract )
First Posted: July 19, 2018    Key Record Dates
Results First Posted: December 11, 2020
Last Update Posted: January 21, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual data will be available upon request to the PI Dr. Sara Becker via email.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Analytic Code
Time Frame: Within 6 months of study completion for next 7 years
Access Criteria: Contact the Study PI

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brown University:
adolescent
substance use
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders