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Feasibility Study of UP-A-AST Parent Group for Adolescents With Autism and Co-occurring Anxiety/Depression

9 de junio de 2026 actualizado por: Karin Melin, Sahlgrenska University Hospital

Unified Protocol-Adolescent Autism Parent Group (UP-A-AST) for Adolescents With Autism Spectrum Disorder and Co-occurring Anxiety and/or Depressive Disorders: A Feasibility Study

Autism spectrum disorder (ASD) is associated with high rates of psychiatric comorbidity, particularly anxiety and depressive disorders, which contribute to significant impairment for affected youth and their families. Although cognitive behavioral therapy (CBT) is recommended as a first-line treatment for anxiety and depression in children and adolescents, there is a lack of evidence-based interventions specifically adapted for youth with ASD and co-occurring emotional disorders.

The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents (UP-C/UP-A) is a CBT-based intervention targeting shared mechanisms underlying anxiety and depression. A parent-mediated adaptation, the Unified Protocol-Adolescent Autism Parent Group (UP-A-AST), has been developed to address the specific needs of adolescents with ASD and co-occurring anxiety and/or depressive disorders. Preliminary quality improvement work has shown promising results.

This study aims to evaluate the feasibility, acceptability, and preliminary effects of the UP-A-AST Parent Group in a child and adolescent outpatient psychiatric setting. The study will include parents of adolescents aged 12-17 years with ASD and co-occurring anxiety and/or depressive disorders. Outcomes include changes in adolescents' psychiatric symptoms and functional impairment, as well as parents' perceived parenting competence. Additionally, parents' experiences of participating in the intervention will be explored.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

72

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.

Estudio Contacto

Copia de seguridad de contactos de estudio

  • Nombre: Sahlgrenska University Hospital
  • Número de teléfono: +46313421000

Ubicaciones de estudio

  • Suecia
      • Gothenburg, Suecia, 41345
        • Reclutamiento
        • BUP- Specialmottagning, Sahlgrenska University Hospital
        • Contacto:
          • Karin Melin, PhD

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

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Adolescents aged 12-17 years
  • Clinical diagnosis of autism spectrum disorder (ASD) according to DSM-IV, DSM-5, or ICD-10
  • Current diagnosis of anxiety disorder and/or depressive disorder according to DSM-5
  • Ongoing contact with a Child and Adolescent Psychiatry (BUP) outpatient clinic
  • Stable psychopharmacological treatment at the time of inclusion (if applicable)
  • Parents has participated in a psychoeducational program on autism within child and adolescent psychiatric services, or is assessed by the clinician to have equivalent knowledge

Exclusion Criteria:

  • Presence of a severe psychiatric disorder, such as psychotic disorder, bipolar disorder, or severe eating disorder
  • High suicide risk or suicide attempt within the past 12 months
  • Severe self-injurious behavior
  • Intellectual disability according to DSM-5
  • The adolescent is primarily in need of basic interventions for autism spectrum disorder
  • Parents are unable to attend all group sessions and/or lack the ability to engage in assigned home practice
  • Need for an interpreter

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
Experimental: UP-A-AST Parent Group
Participants receive the Unified Protocol-Adolescent Autism Parent Group (UP-A-AST), a parent-mediated, group-based cognitive behavioral intervention adapted for adolescents with autism spectrum disorder and co-occurring anxiety and/or depressive disorders. The intervention is delivered to parents in a group format and focuses on enhancing understanding of emotional difficulties and providing strategies to support adolescents' emotion regulation and functioning
Otro: Unified Protocol-Adolescent Autism Parent Group (UP-A-AST)
The intervention is delivered in a group format to parents and focuses on strengthening parenting skills and promoting the adolescent's mental health and functional outcomes.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from baseline in RCADS Total Score through 3-Month Follow-up.
Periodo de tiempo: Baseline, at completion of the intervention (10 weeks) and 3 months post intervention
Anxiety and depressive symptom severity will be assessed using the parent-reported version of the Revised Child Anxiety and Depression Scale (RCADS), a validated questionnaire measuring symptoms of anxiety and depression in children and adolescents.Total scores range from 0 to 141, with higher scores indicating greater symptom severity .
Baseline, at completion of the intervention (10 weeks) and 3 months post intervention

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from baseline in Child Anxiety Life Interference Scale-Revised, Parent Version (CALIS-R) total Score at 3-Month follow-up
Periodo de tiempo: Baseline, at completion of the intervention (10 weeks) and 3 months post intervention
Functional impairment related to anxiety will be assessed using the Child Anxiety Life Interference Scale-Revised, Parent Version (CALIS-R), a 16-item parent-report measure assessing the impact of the child's anxiety on functioning within and outside the family, as well as the impact on parental functioning. Total scores range from 0 to 64, with higher scores indicating greater anxiety-related interference .
Baseline, at completion of the intervention (10 weeks) and 3 months post intervention
Change From Baseline in Brief Parental Self-Efficacy Scale (BPSES) Total Score at 3-Month Follow-up
Periodo de tiempo: Baseline, at completion of the intervention (10 weeks) and 3 months post intervention
Parental self-efficacy will be assessed using the Brief Parental Self-Efficacy Scale (BPSES), a five-item self-report measure evaluating parents' perceived competence and confidence in their parenting role. Total scores range from 5 to 30, with higher scores indicating greater parental self-efficacy .
Baseline, at completion of the intervention (10 weeks) and 3 months post intervention
Parent-reported experience of participation in the intervention UP-A-AST Parent Group
Periodo de tiempo: At completion of the intervention (12 weeks)
Parent experiences of participating in the intervention will be assessed using the Evaluation of the UP-A-AST Parent Group, a study-specific questionnaire developed for this intervention. The questionnaire consists of six items rated on a 10-point scale, yielding a total score ranging from 0 to 60, with higher scores indicating a more positive experience of participation. The questionnaire also includes three open-ended questions regarding positive aspects of the parent group, aspects that participants would have preferred to be different, and any additional comments or reflections.
At completion of the intervention (12 weeks)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Sahlgrenska University Hospital

Investigadores

  • Investigador principal: Karin Melin, PhD, Sahlgrenska University Hospital

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)

5 de enero de 2026

Finalización primaria (Estimado)

30 de diciembre de 2026

Finalización del estudio (Estimado)

30 de marzo de 2027

Fechas de registro del estudio

Enviado por primera vez

31 de marzo de 2026

Primero enviado que cumplió con los criterios de control de calidad

9 de junio de 2026

Publicado por primera vez (Actual)

10 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

9 de junio de 2026

Última verificación

1 de marzo de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2025-05437-01

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

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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