Back to resultsM-Health for Teen Substance Abuse and Mental Illness Pilot
Primary Purpose
Substance Use Disorders, Post Traumatic Stress Disorder, Adolescent Behavior
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mobile Application (working name: Bright Path)
Sponsored by
About this trial
This is an interventional treatment trial for Substance Use Disorders
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mobile App
Arm Description
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).
Outcomes
Primary Outcome Measures
Percent of patients retained in study protocol
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.
Provider satisfaction assessed by Treatment Evaluation Inventory-Short Form (TEI-SF)
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.
Adolescent satisfaction assessed by the Client Satisfaction Questionnaire (CSQ)
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.
Patient Engagement assessed by the Child Improvement Rating Scale (CIRS)
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.
Secondary Outcome Measures
Substance Use Disorder (SUD) Symptoms measured by CRAFFT
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.
Substance Use Disorder (SUD) Symptoms assessed by the Drug Abuse Screening Test for Adolescents (DAST-20-A)
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).
Post-Traumatic Stress Disorder (PTSD) Symptoms (If applicable)
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)
Therapeutic alliance as measured by the Therapeutic Alliance Scale for Children-Revised (TASC-R)
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.
Full Information
NCT ID
NCT04281719
First Posted
January 31, 2020
Last Updated
March 28, 2022
Sponsor
Indiana University
Collaborators
Health Information Technology Solutions (HITS) LLC
1. Study Identification
Unique Protocol Identification Number
NCT04281719
Brief Title
M-Health for Teen Substance Abuse and Mental Illness Pilot
Official Title
M-Health for Teen Substance Abuse and Mental Illness: Component III
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Unanticipated technical issues and COVID-19 related-disruptions precluded enrollment of participants before the end of the award period.
Study Start Date
August 1, 2020 (Anticipated)
Primary Completion Date
August 1, 2021 (Anticipated)
Study Completion Date
August 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Health Information Technology Solutions (HITS) LLC
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
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders, Post Traumatic Stress Disorder, Adolescent Behavior, Mental Health Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mobile App
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Mobile Application (working name: Bright Path)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent of patients retained in study protocol
Description
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.
Time Frame
4 months post-baseline
Title
Provider satisfaction assessed by Treatment Evaluation Inventory-Short Form (TEI-SF)
Description
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.
Time Frame
4 months post-baseline
Title
Adolescent satisfaction assessed by the Client Satisfaction Questionnaire (CSQ)
Description
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.
Time Frame
4 months post-baseline
Title
Patient Engagement assessed by the Child Improvement Rating Scale (CIRS)
Description
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.
Time Frame
4 months post-baseline
Secondary Outcome Measure Information:
Title
Substance Use Disorder (SUD) Symptoms measured by CRAFFT
Description
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.
Time Frame
4 months post-baseline
Title
Substance Use Disorder (SUD) Symptoms assessed by the Drug Abuse Screening Test for Adolescents (DAST-20-A)
Description
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).
Time Frame
4 months post-baseline
Title
Post-Traumatic Stress Disorder (PTSD) Symptoms (If applicable)
Description
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)
Time Frame
4 months post-baseline
Title
Therapeutic alliance as measured by the Therapeutic Alliance Scale for Children-Revised (TASC-R)
Description
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.
Time Frame
4 months post-baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zachary W Adams, PhD
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
M-Health for Teen Substance Abuse and Mental Illness Pilot
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