- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04281719
M-Health for Teen Substance Abuse and Mental Illness Pilot
March 28, 2022 updated by: Zachary W. Adams, Indiana University
M-Health for Teen Substance Abuse and Mental Illness: Component III
The study is exploring the ease and ability to integrate a mobile application in outpatient behavioral health treatment.
There are two major aims to the study: 1) Determine feasibility and acceptability of integrating a mobile app into behavioral health treatment for adolescents with co-occurring substance use and mental health disorders, and 2) identify initial signal of effect on engagement and/or treatment outcomes among youth who use the mobile app.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
The purpose of the trial will be to demonstrate the feasibility of the proposed methodology (rate of recruitment, retention at 4-month follow-up, study procedures) as well as estimates of effect on key variables (patient engagement, patient symptoms, use of e-tools, treatment efficiency) in preparation for future studies in this line evaluating the utility of the mobile app.
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 17 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria for Adolescents:
- Aged 14-17 years
- Current substance use disorder (SUD)
- Co-occurring mental health disorder
- Treatment-seeking
- English-speaking (Only English documents will be used throughout the course of this research study)
Exclusion Criteria for Adolescents:
- Younger than 14 or older than 17
- Endorsement of active suicidal or homicidal ideation
- Active mania or psychosis
- Significant cognitive disability, developmental delays, or pervasive developmental disability
- No history of outpatient psychotherapy.
Inclusion Criteria for Providers
- Clinician delivering outpatient dual diagnosis treatment (i.e., for co-occurring SUDs and mental health disorders)
- Therapist with at least a Master's degree in a counseling related field
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Mobile App
Youth will be assigned to interact with a novel mobile application during a course of outpatient psychotherapy for substance use disorder(s) and co-occurring mental health disorder(s).
|
The Bright Path web-based mobile application is designed to target co-occurring problems, enhance patient treatment engagement, and contribute to lasting improvements in teens' mental health.
The central hypothesis is that developmentally tailored mobile applications that incorporate evidence-based treatment principles can facilitate increased patient engagement in and between sessions, thus, improving the efficiency, efficacy, and reach of treatments for this highly vulnerable population.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of patients retained in study protocol
Time Frame: 4 months post-baseline
|
Retention of >75% of adolescents through assessments measured by study participant enrollment records.
The retention rate will be measured by the number of sessions attended.
|
4 months post-baseline
|
Provider satisfaction assessed by Treatment Evaluation Inventory-Short Form (TEI-SF)
Time Frame: 4 months post-baseline
|
Providers express high satisfaction with e-tools per published norms on the TEI-SF.
The Treatment Evaluation Inventory Short Form (TEI-SF) is a 9-item questionnaire that is rated on a 5-point scale.
Scores range from 9 to 45 for each treatment with higher scores indicating greater acceptability of the model.
|
4 months post-baseline
|
Adolescent satisfaction assessed by the Client Satisfaction Questionnaire (CSQ)
Time Frame: 4 months post-baseline
|
Adolescents express high satisfaction with e-tools per published norms.
The Client Satisfaction Questionnaire-8, an 8 question survey with ratings from 1 to 4 is used.
Scores can range from 8 to 32 with higher scores indicating greater satisfaction.
|
4 months post-baseline
|
Patient Engagement assessed by the Child Improvement Rating Scale (CIRS)
Time Frame: 4 months post-baseline
|
Provider-rated youth engagement in treatment process.This will be assessed by the Child Involvement Rating Scale (CIRS) which is a 6 item questionnaire with each item being rated on a 6 item scale ranging from 0 to 5. The questionnaire contains 4 items assessing positive involvement and 2 items assessing negative involvement.
The positive items are scored according to the selected scale value while the negative involvement items are reverse scored.
Higher scores correspond to greater perceived patient involvement.
|
4 months post-baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Substance Use Disorder (SUD) Symptoms measured by CRAFFT
Time Frame: 4 months post-baseline
|
Providers record a decrease in SUD symptoms for patients participating in the study and treatment.
The CRAFFT, a 6-item questionnaire in which every "yes" scores 1 point is used to measure substance abuse and dependence.
A score of 2 or higher indicates a positive screening.
|
4 months post-baseline
|
Substance Use Disorder (SUD) Symptoms assessed by the Drug Abuse Screening Test for Adolescents (DAST-20-A)
Time Frame: 4 months post-baseline
|
Providers record a decrease in SUD symptoms for patients participating in the study and treatment.
The Drug Abuse Screening Test-20 Adolescent Version (DAST-20-A) is a 20-item self-report questionnaire.
Higher scores indicate a greater severity in substance use and can be broken down into the following ranges: 0 (n/a), 1-5 (low), 6-10 (intermediate, likely meets DSM criteria), 11-15 (substantial), 16-20 (severe).
|
4 months post-baseline
|
Post-Traumatic Stress Disorder (PTSD) Symptoms (If applicable)
Time Frame: 4 months post-baseline
|
Providers record a decrease in PTSD symptoms for patients participating in the study and treatment.
The PTSD Symptom Scale for DSM-5 (CPSS-5) is used for evaluation.
The CPSS-5 is a 20-item symptom checklist in which symptom severity can be rated from 0 to 4. Higher scores indicate greater symptom severity and can be broken down into the following ranges: 0-10 (minimal), 11-20 (mild), 21-40 (moderate), 41-60 (severe), 61-80 (very severe)
|
4 months post-baseline
|
Therapeutic alliance as measured by the Therapeutic Alliance Scale for Children-Revised (TASC-R)
Time Frame: 4 months post-baseline
|
Providers record high therapeutic alliance per published norms.
The TASC-R includes 12 items rated on a Likert scale from 1 (not true) to 4 (very much true), with item scores summed for a total, where higher scores correspond to higher therapeutic alliance.
|
4 months post-baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Zachary W Adams, PhD, Indiana University School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
August 1, 2020
Primary Completion (ANTICIPATED)
August 1, 2021
Study Completion (ANTICIPATED)
August 1, 2021
Study Registration Dates
First Submitted
January 31, 2020
First Submitted That Met QC Criteria
February 21, 2020
First Posted (ACTUAL)
February 24, 2020
Study Record Updates
Last Update Posted (ACTUAL)
April 6, 2022
Last Update Submitted That Met QC Criteria
March 28, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1908720822
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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