M-Health for Teen Substance Abuse and Mental Illness Pilot

NCT04281719 | Withdrawn DMC

• 1 other identifier: 1908720822
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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.

  4 months post-baseline

• 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.

  4 months post-baseline

• 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.

  4 months post-baseline

• 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.

  4 months post-baseline

Secondary Outcomes (4)

• 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

• Therapeutic alliance as measured by the Therapeutic Alliance Scale for Children-Revised (TASC-R)

  4 months post-baseline

Study Arms (1)

Mobile App

EXPERIMENTAL

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).

Other: Mobile Application (working name: Bright Path)

Interventions

Mobile Application (working name: Bright Path) OTHER

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.

Mobile App

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Indiana University: lead
• Health Information Technology Solutions (HITS) LLC: collaborator

MeSH Terms

Conditions

Substance-Related Disorders; Stress Disorders, Post-Traumatic; Adolescent Behavior; Mental Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Behavior

Study Officials

• Zachary W Adams, PhD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 24, 2020
• Study Start: August 1, 2020
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: April 6, 2022

Record last verified: 2022-03