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NCT Number: NCT07637799

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

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.

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Key information

Conditions

Autistic Spectrum Disorder Anxiety Disorders Autism Spectrum Disorder Child Development Disorders, Pervasive Depressive Disorder Mental Disorders Mood Disorders Neurodevelopmental Disorders

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BUP- Specialmottagning, Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location status: Recruiting

Location contact

Karin Melin, PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Unified Protocol-Adolescent Autism Parent Group (UP-A-AST)

Other

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.

Primary outcomes

  1. Change from baseline in RCADS Total Score through 3-Month Follow-up.

    Time frame: 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 .

Secondary outcomes

  1. Change from baseline in Child Anxiety Life Interference Scale-Revised, Parent Version (CALIS-R) total Score at 3-Month follow-up

    Time frame: 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 .

  2. Change From Baseline in Brief Parental Self-Efficacy Scale (BPSES) Total Score at 3-Month Follow-up

    Time frame: 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 .

  3. Parent-reported experience of participation in the intervention UP-A-AST Parent Group

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Karin Melin, PhD

CONTACT

[email protected]

+46730494348

Sahlgrenska University Hospital

CONTACT

+46313421000

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 10, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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