Transdiagnostic Group Behavioral Activation for Autistic Adults (GBAT)
3 agosto 2021 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
6
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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New Jersey
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Piscataway, New Jersey, Stati Uniti, 08854
- Rutgers University
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 40 anni (Adulto)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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).
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: GBAT
10-week behavioral activation treatment group.
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in symptoms on the Adult Self Report (ASR)
Lasso di tempo: 10 week study period; 4 week post-treatment
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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
Lasso di tempo: 10 week study period;
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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;
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in symptoms on the Depression Anxiety Stress Scales-21
Lasso di tempo: 10 week study period; 4 week post-treatment
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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)
Lasso di tempo: 10 week study period
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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.
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10 week study period
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Change in anxiety symptoms on the Generalized Anxiety Disorder Questionnaire (GAD-7)
Lasso di tempo: 10 week study period
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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)
Lasso di tempo: 10 week study period
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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.
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10 week study period
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Change in Behavioral Activation for Depression Scale
Lasso di tempo: 10 week study period; 4 week post-treatment
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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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
16 febbraio 2021
Completamento primario (Effettivo)
8 luglio 2021
Completamento dello studio (Effettivo)
8 luglio 2021
Date di iscrizione allo studio
Primo inviato
4 marzo 2021
Primo inviato che soddisfa i criteri di controllo qualità
4 marzo 2021
Primo Inserito (Effettivo)
9 marzo 2021
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
5 agosto 2021
Ultimo aggiornamento inviato che soddisfa i criteri QC
3 agosto 2021
Ultimo verificato
1 agosto 2021
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Pro2020001634
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .