Skip to main content
Clinical Trials/NCT04281719
NCT04281719
Withdrawn
Not Applicable

M-Health for Teen Substance Abuse and Mental Illness: Component III

Indiana University0 sitesAugust 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Substance Use Disorders
Sponsor
Indiana University
Primary Endpoint
Percent of patients retained in study protocol
Status
Withdrawn
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2020
End Date
August 1, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zachary W. Adams

Assistant Professor

Indiana University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

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.

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.

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.

Secondary Outcomes

  • Therapeutic alliance as measured by the Therapeutic Alliance Scale for Children-Revised (TASC-R)(4 months post-baseline)
  • Substance Use Disorder (SUD) Symptoms measured by CRAFFT(4 months post-baseline)
  • Substance Use Disorder (SUD) Symptoms assessed by the Drug Abuse Screening Test for Adolescents (DAST-20-A)(4 months post-baseline)
  • Post-Traumatic Stress Disorder (PTSD) Symptoms (If applicable)(4 months post-baseline)

Similar Trials