Autistic Spectrum DisorderNCT07637799
Feasibility Study of UP-A-AST Parent Group for Adolescents With Autism and Co-occurring Anxiety/Depression
A study testing Unified Protocol-Adolescent Autism Parent Group (UP-A-AST) in people with Autistic Spectrum Disorder and Anxiety Disorders, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Autistic Spectrum Disorder, Anxiety Disorders, Depressive Disorder
- What is being tested?
- Unified Protocol-Adolescent Autism Parent Group (UP-A-AST)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSweden
- Study dates
- 5 Jan 2026to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sahlgrenska University Hospital contact
Sweden1 site, 1 recruiting
- Recruiting
BUP- Specialmottagning, Sahlgrenska University Hospital
Gothenburg, 41345
Karin Melin, PhD
About this study
Official 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
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.
- Being tested
- Unified Protocol-Adolescent Autism Parent Group (UP-A-AST)
- Medical subject headings
- Autism Spectrum Disorder, Anxiety Disorders, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Unified Protocol-Adolescent Autism Parent Group (UP-A-AST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 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
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 .
Measured: 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
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 .
Measured: 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
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.
Measured: At completion of the intervention (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start5 Jan 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autistic Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karin Melin, Sahlgrenska University Hospital
- Investigators
- Karin Melin, PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07637799
- Sponsor's protocol ID
- 2025-05437-01
- Other IDs
- 2025
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07637799
- Acronym / sponsor ID
- 2025-05437-01
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UP-A-AST Parent Group | Experimental | Other: Unified Protocol-Adolescent Autism Parent Group (UP-A-AST)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 |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | UP-A-AST Parent Group |
Primary outcome
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 .
3 secondary outcomes
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
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
Parent-reported experience of participation in the intervention UP-A-AST Parent Group
Time frame: At completion of the intervention (12 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sahlgrenska University Hospital contact
Karin Melin, PhD principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unified Protocol-Adolescent Autism Parent Group (UP-A-AST) in people with Autistic Spectrum Disorder and Anxiety Disorders, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karin Melin, PhD (+46730494348, karin.a.melin@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.