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Automated Assessment Using Facial Coding (R44DA042640)

25. April 2022 aktualisiert von: Treatment Innovations
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.

Studienübersicht

Detaillierte Beschreibung

Transition-age youth (TAY) from ages 18-26 are especially vulnerable to substance use, misuse, and substance use disorder (SUD). This developmental period, termed the "age of instability" and "emerging adulthood" includes tasks such as leaving home, entering college; identifying vocational goals; working for the first time; body and sexuality changes; coalescing with a peer group; 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 such as binge drinking, driving under the influence, accidents, fighting and violence, HIV, gang involvement, suicide and self-harm, and vulnerability to date-rape and other sexual assault. 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 is often described as a short-term way to regulate emotion and there is a long-standing literature documenting the association between emotion regulation (ER) problems and SUD. The importance of ER is also grounded in the developmental literature in which 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, especially for people with SUD as they are often not aware of their feelings or confused about them due to the nature of the disorder as well as mental health disorders that often co-occur with SUD. The phase 1 project developed and evaluated a mobile app that uses exciting new technology (automated emotion detection) to help TAY better recognize their emotions in relation to SUD variables. Highly positive results were found in the phase 1 feasibility / pilot study and are now proposing a phase 2 project to continue this work. In phase 2 the app will continue to be developed based on user experience based on end-user feedback and an expert consultant team. Phase 2 also includes a randomized controlled trial to evaluate the app among TAY with SUD. They will have six weeks to use the app in their natural environment, such as home, and will complete pre- and post-evaluation using validated instrumts to compare outcomes between two conditions: the app condition and a control-app condition. The primary outcomes are substance use and emotion regulation. End-user satisfaction with the app will also be obtained as well as app metrics. The app product could have major public health and clinical impact. It could help improve TAY's ability to become more aware of their emotions and understand them in relation to SUD via an exciting emotion-focused technology innovation. If the product is successful it could also be expanded to other populations. The collaborative team includes experts in SUD, TAY, clinical innovations, technology, and app development.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

153

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Massachusetts
      • Newton, Massachusetts, Vereinigte Staaten, 02459
        • Lisa Najavits

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 26 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria: ages 18-26; outpatient; meets criteria for current SUD based on either verification from a professional or via assessment by our team using DSM-5 criteria; has an iPhone; and is not in an environment that restricts substance use (so that our SUD outcomes will be naturalistic).

Exclusion Criteria:

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Experimental app
This is the Advanced Emotion App that we initially developed in phase 1 and are now enhancing in phase 2.
The app is designed to help TAY better recognize their emotions using enhanced features
Aktiver Komparator: Comparison app
This is the Basic Emotion App, which is an alternative intervention app that controls for time and attention.
The app is designed to help TAY better recognize their emotions using basic features

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in emotion regulation
Zeitfenster: baseline and 6 weeks
Composite of the Toronto Alexithymia Scale and the Difficulties in Emotion Regulation Scale
baseline and 6 weeks
Change in substance use
Zeitfenster: baseline and 6 weeks
Brief Addiction Monitor
baseline and 6 weeks

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in psychiatric symptoms
Zeitfenster: baseline and 6 weeks
Brief Symptom Inventory
baseline and 6 weeks
Change in coping
Zeitfenster: baseline and 6 weeks
Coping Self-Efficacy Scale
baseline and 6 weeks
Change in stress
Zeitfenster: baseline and 6 weeks
Perceived Stress Scale
baseline and 6 weeks
Change in distress tolerance
Zeitfenster: baseline and 6 weeks
Distress Tolerance Scale
baseline and 6 weeks
Change in functioning
Zeitfenster: baseline and 6 weeks
BASIS-32
baseline and 6 weeks

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Lisa Najavits, Treatment Innovations

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Oktober 2020

Primärer Abschluss (Tatsächlich)

1. März 2022

Studienabschluss (Tatsächlich)

1. März 2022

Studienanmeldedaten

Zuerst eingereicht

25. Mai 2018

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. Juni 2018

Zuerst gepostet (Tatsächlich)

11. Juni 2018

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

27. April 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

25. April 2022

Zuletzt verifiziert

1. April 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • 2R44DA042640-02 (US NIH Stipendium/Vertrag)

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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