Feasibility Study of UP-A-AST Parent Group for Adolescents With Autism and Co-occurring Anxiety/Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12+
SponsorSahlgrenska University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Unified Protocol-Adolescent Autism Parent Group (UP-A-AST)
Other interventionThe 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.
Treatment groups
72 Participants
are divided into 1 treatment groupGroup A: UP-A-AST Parent GroupExperimental treatment 1 intervention
Trial outcomes
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 interventionSecondary 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 intervention2
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 intervention3
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)Sponsors and contacts
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Source ClinicalTrials.gov