Transdiagnostic Group Behavioral Activation for Autistic Adults (GBAT)
3 de agosto de 2021 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
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 de estudio
Intervencionista
Inscripción (Actual)
6
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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New Jersey
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Piscataway, New Jersey, Estados Unidos, 08854
- Rutgers University
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 40 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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).
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in symptoms on the Adult Self Report (ASR)
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in symptoms on the Depression Anxiety Stress Scales-21
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
16 de febrero de 2021
Finalización primaria (Actual)
8 de julio de 2021
Finalización del estudio (Actual)
8 de julio de 2021
Fechas de registro del estudio
Enviado por primera vez
4 de marzo de 2021
Primero enviado que cumplió con los criterios de control de calidad
4 de marzo de 2021
Publicado por primera vez (Actual)
9 de marzo de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de agosto de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
3 de agosto de 2021
Última verificación
1 de agosto de 2021
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Pro2020001634
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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