Clinical trial NCT04281719: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Substance Use Disorders
Post Traumatic Stress Disorder
Adolescent Behavior
Mental Health Disorder
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Health Information Technology Solutions (HITS) LLC
First posted: 2020-02-24
Enrollment: 0
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percent of patients retained in study protocol
timeFrame: 4 months post-baseline
measure: Provider satisfaction assessed by Treatment Evaluation Inventory-Short Form (TEI-SF)
timeFrame: 4 months post-baseline
measure: Adolescent satisfaction assessed by the Client Satisfaction Questionnaire (CSQ)
timeFrame: 4 months post-baseline
measure: Patient Engagement assessed by the Child Improvement Rating Scale (CIRS)
timeFrame: 4 months post-baseline
Secondary outcomes:
measure: Substance Use Disorder (SUD) Symptoms measured by CRAFFT
timeFrame: 4 months post-baseline
measure: Substance Use Disorder (SUD) Symptoms assessed by the Drug Abuse Screening Test for Adolescents (DAST-20-A)
timeFrame: 4 months post-baseline
measure: Post-Traumatic Stress Disorder (PTSD) Symptoms (If applicable)
timeFrame: 4 months post-baseline
measure: Therapeutic alliance as measured by the Therapeutic Alliance Scale for Children-Revised (TASC-R)
timeFrame: 4 months post-baseline
Other outcomes:
Locations:
Study officials:
affiliation: Indiana University School of Medicine
name: Zachary W Adams, PhD
role: PRINCIPAL_INVESTIGATOR
References: