Automated Assessment Using Facial Coding

NCT03551886 | Completed

• 1 other identifier: 2R44DA042640-02
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

Transition-age youth (TAY) from ages 18-26 are vulnerable to substance substance use disorder (SUD). This developmental period, termed "emerging adulthood" includes leaving home, entering college or working for the first time; and for some, aging out of foster care or state custody, which end at age 18. The emerging-adulthood period is prime for experimentation with substances and the development of SUD, and associated problems. A major challenge for TAY is the capacity to regulate their emotions, given the hormone changes and emotional intensity of this stage of life. Indeed, substance use can be a short-term way to regulate emotion. The importance of ER is identified as a core skill that is critical to the successful transition to adulthood. The initial component of ER, accurate identification of emotion, is itself a major challenge. In the phase 1 project a mobile app was developed that uses automated emotion detection to help TAY better recognize their emotions in relation to SUD. We found positive results in our phase 1 study. Phase 2 will see the continuation of the development of the app features. Phase 2 also includes a randomized controlled trial to evaluate the app among TAY with SUD in their natural environment, such as home, and we will conduct pre- and post-evaluation to compare outcomes between the app condition and a control-app condition. The primary outcomes are substance use and emotion regulation. User satisfaction, feedback at the end of phase 2 and app metrics will also be explored. The app can potentially have major public health and clinical impact. It could help improve TAY's ability to become more aware of emotions and understand them in relation to SUD via emotion-focused technoloy. If the product is successful it could be expanded to other populations.

Conditions

Substance Use Disorders

Outcome Measures

Primary Outcomes (2)

• Change in emotion regulation

  Composite of the Toronto Alexithymia Scale and the Difficulties in Emotion Regulation Scale

  baseline and 6 weeks

• Change in substance use

  Brief Addiction Monitor

  baseline and 6 weeks

Secondary Outcomes (5)

• Change in psychiatric symptoms

  baseline and 6 weeks

• Change in coping

  baseline and 6 weeks

• Change in stress

  baseline and 6 weeks

• Change in distress tolerance

  baseline and 6 weeks

• Change in functioning

  baseline and 6 weeks

Study Arms (2)

Experimental app

EXPERIMENTAL

This is the Advanced Emotion App that we initially developed in phase 1 and are now enhancing in phase 2.

Behavioral: Advanced Emotion App

Comparison app

ACTIVE COMPARATOR

This is the Basic Emotion App, which is an alternative intervention app that controls for time and attention.

Behavioral: Basic Emotion App

Interventions

Advanced Emotion App BEHAVIORAL

The app is designed to help TAY better recognize their emotions using enhanced features

Experimental app

Basic Emotion App BEHAVIORAL

The app is designed to help TAY better recognize their emotions using basic features

Comparison app

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• current uncontrolled psychotic or bipolar disorder as the priority for such clients would be to stabilize them on medication; currently suicidal or violent with intent and/or plan; and/or SUD so severe that detoxification is needed, with any of these criteria reported by the TAY and/or a clinical treater. We will not restrict any treatments, self-help or other care of the TAY.

Sponsors & Collaborators

• Treatment Innovations: lead

Study Sites (1)

Lisa Najavits

Newton, Massachusetts, 02459, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Lisa Najavits

  Treatment Innovations

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: June 11, 2018
• Study Start: October 1, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: April 27, 2022

Record last verified: 2022-04

Locations

US (1)