Transdiagnostic Group Behavioral Activation for Autistic Adults (GBAT)
3. August 2021 aktualisiert von: Vanessa H. Bal, PhD, Rutgers, The State University of New Jersey
Adaptation of a Transdiagnostic Behavioral Activation Telehealth Group for Autistic Adults
The purpose of this study is to evaluate the feasibility, acceptability and effectiveness of a telehealth Group Behavioral Activation Therapy (GBAT) for autistic adults.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Detailed Description: This study is being done to demonstrate the feasibility, acceptability and effectiveness of a telehealth Group Behavioral Activation Therapy (GBAT) for autistic adults.
GBAT is intended to help adults manage stress, anxiety, down moods, and anger.
Similar programs have been shown to be effective in other contexts but has not yet been used for autistic adults or delivered via telehealth.
Because this is a new intervention, the investigators are interested in learning 1) whether GBAT can be done with autistic adults (feasibility), 2) what autistic adults think about GBAT (acceptability), and 3) whether GBAT is effective for helping autistic adults cope with their feelings.
Results from this study will be used to inform adaptation to the intervention and planning for future studies to further explore its effectiveness.
For this initial feasibility study, 8 autistic adults (18-40 years old) with VIQ and NVIQ>85, reading composite at least 6th grade level and elevated symptoms of depression, anxiety or anger will be recruited.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
6
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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New Jersey
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Piscataway, New Jersey, Vereinigte Staaten, 08854
- Rutgers University
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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 40 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Be 18-40 years old
- Have a confirmed diagnosis of Autism Spectrum Disorders (ASD).
- Have access to a device (e.g., computer with a webcam or smartphone) in order to complete online surveys and participate in the telehealth videoconferencing sessions
- *Have a VIQ and NVIQ of 85 or above
- *Have at least a 6th grade reading composite
- *Have elevated symptoms of depression, anxiety or anger. This will be determined based on scoring above the borderline or mild threshold on at least one of 3 screening measures (MINI; ASR; DASS-21).
Exclusion Criteria:
- Are younger than 18 years old, or older than 40 years old (Children are excluded because the focus is on adapting GBAT for adults; Individuals above 40 are excluded to restrict the adult focus to young adults that are more likely to be in similar life stages).
- Do not have an ASD diagnosis (because the study as the purpose of the current research is to examine GBAT's feasibility with autistic adults).
- Both VIQ and NVIQ below 85 OR less than 6th grade reading level
- Do not have elevated scores of depression, anxiety, or anger on the symptom screening measures.
- Are unable to understand English fluently (because the instruments being investigated are currently only validated in English and the intervention will be delivered in English).
- Are currently enrolled in another behavioral therapy or psychotherapy targeting depression,
- the PI's clinical judgment that it would not be in the adult's best interest to be enrolled (e.g., due to factors that may affect their engagement or comfort in the group).
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: GBAT
10-week behavioral activation treatment group.
|
This will be a modification of the Group Behavioral Activation Therapy program (Chu et al., 2009) for treatment of depression, anxiety and/or anger in autistic adults.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in symptoms on the Adult Self Report (ASR)
Zeitfenster: 10 week study period; 4 week post-treatment
|
The ASR is a an assessment of adult psychopathology (e.g., anxiety, depression symptoms).
Most of the items are on a 3 point scale including: (0) Not true, (1) Somewhat or sometimes true, and (2) Very often or often true.
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10 week study period; 4 week post-treatment
|
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Change in Clinician Global Impairment rating
Zeitfenster: 10 week study period;
|
The CGI is a 7 point scale on which the clinician rates the severity of the client's impairment.
The scale ranges from 1 (Normal, not at all ill) to 7 Extremely Ill; higher scores indicate more impairment.
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10 week study period;
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in symptoms on the Depression Anxiety Stress Scales-21
Zeitfenster: 10 week study period; 4 week post-treatment
|
The DASS-21 is a 21-item measure of depression and anxiety symptoms.
The measure produces scores in 3 domains: depression, anxiety, and stress.
The score ranges on each domain is from 0-42.
Higher scores on each domain indicate more impairment/ severity.
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10 week study period; 4 week post-treatment
|
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Change in distress on Patient Health Questionnaire (PHQ-9)
Zeitfenster: 10 week study period
|
The PHQ-9, assessed weekly, is a 9-item questionnaire of psychological function over the past week with all items on a "0" (not at all) to "3" (nearly every day) scale.
Total scores range from 0 to 27; higher scores reflect greater levels of depressive symptoms.
|
10 week study period
|
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Change in anxiety symptoms on the Generalized Anxiety Disorder Questionnaire (GAD-7)
Zeitfenster: 10 week study period
|
The GAD-7, assessed weekly, is a 7-item questionnaire of anxiety symptoms over the past week with all items on a "0" (not at all) to "3"(nearly every day) scale.
Total scores range from 0 to 21; higher scores reflect greater levels of anxiety.
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10 week study period
|
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Change in Adaptive Behavior Assessment System - 3 (ABAS-3)
Zeitfenster: 10 week study period
|
The ABAS-3 is a measure of adaptive function that yields age-standardized scores for three domains (Conceptual, Social and Practical) and an overall Global Adaptive Composite.
Each domain and the overall General Adaptive Composite result in a standard score, with a mean of 100 and a standard deviation of 15 (scores between 86 and 114 are considered "Average" on this instrument; scores under 70 are classified as "Extremely Low" relative to same aged peers).
Each domain is composed of several subdomains that yield scaled scale scores (Mean=10, SD=3), with scores between 7 and 13 falling in the "Average" range.
|
10 week study period
|
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Change in Behavioral Activation for Depression Scale
Zeitfenster: 10 week study period; 4 week post-treatment
|
The BADS is a 25-item measure designed to assess how clients become activated over the course of Behavior Activation treatment. There are 25 questions, each rated on a seven point scale ranging from 0 to 6. There are four subscales: AC = Activation subscale [score range 0 to 42] AR = Avoidance/Rumination subscale [score range 0-48] WS = Work/School Impairment subscale [score range 0-30] SI = Social Impairment subscale [score range 0-30] Higher scores indicate a better outcome on the Activation subscale. Higher scores indicate a worse outcome on the Avoidance/Rumination subscale, Work/School Impairment subscale, and Social Impairment subscale. |
10 week study period; 4 week post-treatment
|
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Change in Idiographic target goals
Zeitfenster: 10 week study period; 4 week post-treatment
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Clients are asked to identify 3 goals they would like to accomplish.
There are no scores or scales.
Each goal is a statement shared by the client relevant to their own experiences.
Target goals are sensitive to change in treatment contexts.
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10 week study period; 4 week post-treatment
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
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)
16. Februar 2021
Primärer Abschluss (Tatsächlich)
8. Juli 2021
Studienabschluss (Tatsächlich)
8. Juli 2021
Studienanmeldedaten
Zuerst eingereicht
4. März 2021
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
4. März 2021
Zuerst gepostet (Tatsächlich)
9. März 2021
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
5. August 2021
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
3. August 2021
Zuletzt verifiziert
1. August 2021
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Pro2020001634
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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