NCT07637799

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress36%
Jan 2026Mar 2027

Study Start

First participant enrolled

January 5, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 10, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2027

Last Updated

June 10, 2026

Status Verified

March 1, 2026

Enrollment Period

12 months

First QC Date

March 31, 2026

Last Update Submit

June 9, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

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

    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

Secondary Outcomes (3)

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

    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

    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

    At completion of the intervention (12 weeks)

Study Arms (1)

UP-A-AST Parent Group

EXPERIMENTAL

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

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

Interventions

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.

UP-A-AST Parent Group

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BUP- Specialmottagning, Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

RECRUITING

MeSH Terms

Conditions

Autism Spectrum DisorderAnxiety DisordersDepressive Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersMood Disorders

Study Officials

  • Karin Melin, PhD

    Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sahlgrenska University Hospital

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 31, 2026

First Posted

June 10, 2026

Study Start

January 5, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

March 30, 2027

Last Updated

June 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations