- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07637799
Feasibility Study of UP-A-AST Parent Group for Adolescents With Autism and Co-occurring Anxiety/Depression
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.
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Karin Melin, PhD
- Telefonnummer: +46730494348
- E-mail: karin.a.melin@vgregion.se
Undersøgelse Kontakt Backup
- Navn: Sahlgrenska University Hospital
- Telefonnummer: +46313421000
Studiesteder
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Gothenburg, Sverige, 41345
- Rekruttering
- BUP- Specialmottagning, Sahlgrenska University Hospital
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Kontakt:
- Karin Melin, PhD
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change from baseline in RCADS Total Score through 3-Month Follow-up.
Tidsramme: Baseline, at completion of the intervention (10 weeks) and 3 months post intervention
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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 .
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Baseline, at completion of the intervention (10 weeks) and 3 months post intervention
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change from baseline in Child Anxiety Life Interference Scale-Revised, Parent Version (CALIS-R) total Score at 3-Month follow-up
Tidsramme: Baseline, at completion of the intervention (10 weeks) and 3 months post intervention
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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 .
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Baseline, at completion of the intervention (10 weeks) and 3 months post intervention
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Change From Baseline in Brief Parental Self-Efficacy Scale (BPSES) Total Score at 3-Month Follow-up
Tidsramme: Baseline, at completion of the intervention (10 weeks) and 3 months post intervention
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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 .
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Baseline, at completion of the intervention (10 weeks) and 3 months post intervention
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Parent-reported experience of participation in the intervention UP-A-AST Parent Group
Tidsramme: At completion of the intervention (12 weeks)
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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.
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At completion of the intervention (12 weeks)
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Karin Melin, PhD, Sahlgrenska University Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2025-05437-01
Plan for individuelle deltagerdata (IPD)
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