ClinicalTrials.gg
RecruitingNCT07637799Updated Jun 10, 2026

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

An interventional study of Unified Protocol-Adolescent Autism Parent Group (UP-A-AST) in Autistic Spectrum Disorder, Anxiety Disorders and Depressive Disorder, sponsored by Sahlgrenska University Hospital. Recruiting at 1 site in Sweden. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-06-10.

Sponsored by Sahlgrenska University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2026; still recruiting 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Not applicable
Ages
12 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Autistic Spectrum Disorder
  • Anxiety Disorders
  • Depressive Disorder
03

In context

Autism Spectrum Disorder

1,724 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.

This study's planned enrollment of 72 is above the median of 52 across 1,368 interventional studies indexed under Autism Spectrum Disorder.

Browse Autism Spectrum Disorder studies →

Lead sponsor

Sahlgrenska University Hospital is the lead sponsor of 263 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adolescents aged 12-17 years
  • Clinical diagnosis of autism spectrum disorder (ASD) according to , 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

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
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
72 participants (estimated)

Study arms

  • 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

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

Interventions

  • OtherUnified 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.

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What researchers measure

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 .

    Time frame: Baseline, at completion of the intervention (10 weeks) and 3 months post intervention

Secondary outcomes

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

    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 .

    Time frame: Baseline, at completion of the intervention (10 weeks) and 3 months post intervention

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

    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 .

    Time frame: Baseline, at completion of the intervention (10 weeks) and 3 months post intervention

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

    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.

    Time frame: At completion of the intervention (12 weeks)

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Study locations

1 of 1 sites recruiting
  • BUP- Specialmottagning, Sahlgrenska University Hospital
    Gothenburg, 41345, Sweden
    Recruiting
    • Karin Melin, PhD · Contact
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2026 (actual). Primary completion is estimated for Dec 2026, 11 months after the start.

Of 800 non-industry interventional studies with no phase under Autism Spectrum Disorder, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 11 months is below that.

Counting every sponsor, half of 823 studies reached it within 25 months; a quarter within 12 and three quarters within 47.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 31, 2026
First posted
Jun 10, 2026
StartActual
Jan 5, 2026
Primary completionEst.
Dec 30, 2026
CompletionEst.
Mar 30, 2027
Last update
Jun 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07637799
Responsible party
Karin Melin (PhD, Sahlgrenska University Hospital) — Principal investigator
First posted
Jun 10, 2026
Start date
Jan 5, 2026
Primary completion
Dec 30, 2026 (estimated)
Completion
Mar 30, 2027 (estimated)
Last update
Jun 10, 2026

Study contacts

Karin Melin, PhD
Contact
karin.a.melin@vgregion.se
+46730494348
Sahlgrenska University Hospital
Contact
+46313421000
Karin Melin, PhD
principal investigator · Sahlgrenska University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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