M-Health for Teen Substance Abuse and Mental Illness Pilot

Not Applicable

Withdrawn

• Conditions: Adolescent Behavior; Post Traumatic Stress Disorder; Substance Use Disorders; Mental Health Disorder

• Registration Number: NCT04281719
• Lead Sponsor: Indiana University

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study First Submitted: 2020-01-31
• Study First Submitted QC: 2020-02-21
• Study First Posted: 2020-02-24
• Study Start: 2020-08-01
• Primary Completion: 2021-08-01
• Study Completion: 2021-08-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-28
• Last Update Posted: 2022-04-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percent of patients retained in study protocol	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.
Provider satisfaction assessed by Treatment Evaluation Inventory-Short Form (TEI-SF)	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.
Adolescent satisfaction assessed by the Client Satisfaction Questionnaire (CSQ)	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.
Patient Engagement assessed by the Child Improvement Rating Scale (CIRS)	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.

Secondary Outcome Measures

Name	Time	Method
Therapeutic alliance as measured by the Therapeutic Alliance Scale for Children-Revised (TASC-R)	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.
Substance Use Disorder (SUD) Symptoms measured by CRAFFT	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.
Substance Use Disorder (SUD) Symptoms assessed by the Drug Abuse Screening Test for Adolescents (DAST-20-A)	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).
Post-Traumatic Stress Disorder (PTSD) Symptoms (If applicable)	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)