NCT05131425Active, not recruiting
Facing Your Fears: Adolescents With ASD and Intellectual Disability
Group Cognitive Behavioral Treatment for Anxiety in Adolescents With ASD and Intellectual Disability: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 8 Jan 2025
Brief summary (registry, in English)
Adolescents with ASD and intellectual disability (ID) are a complex and underserved population. Approximately 50% of individuals with ASD/ID experience significant anxiety. Yet, there are very limited mental health care interventions available for this population. Addressing anxiety and building coping skills is particularly important during adolescence as coping skills can support a successful transition to adulthood and family functioning during a difficult developmental period. The current investigators adapted a cognitive behavioral treatment (CBT) manualized intervention, Facing Your Fears, for adolescents with ASD/ID (FYF:ASD/ID) and completed a pilot study with 23 teens. Preliminary results indicated significant improvements in anxiety and mood symptoms. The proposed study seeks to test whether FYF:ASD/ID is more effective in reducing anxiety than treatment-as-usual (TAU). The investigators propose a Randomized Control Trial (RCT) with 36 adolescents with ASD/ID (12-18 years) randomized to FYF: ASD/ID and 36 adolescents randomized to TAU for 14 weeks. The 36 teens randomized to TAU will then cross-over and complete FYF:ASD/ID. Evaluations will take place at Baseline, Post-Intervention, and 6-month follow-up. Teens in the TAU will have two baseline assessments prior to crossing over to FYF:ASD/ID; both groups will complete a 6-month follow-up assessment after finishing FYF:ASD/ID. There are three aims for this project: (1) examine the efficacy of FYF: ASD/ID relative to TAU in improving anxiety as measured by parent report and determine if any gains noted in the FYF:ASD/ID are maintained at 6-month follow-up; (2) examine secondary outcomes of anxiety such as how emotion regulation and problem behavior are affected by participation in FYF:ASD/ID; and (3) examine whether adolescents' independent use of CBT skills (as assessed by goal attainment ratings of prompting level required to use strategies) to manage anxiety are increased following participation in FYF:ASD/ID.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 73 (actual)
- First submitted
- 8 Jul 2021
- Start date
- 1 Sept 2021
- Primary completion date
- 31 Aug 2024
- Lead sponsor
- University of Colorado, Denver
- Diseases
- Autism
- NCT number
- NCT05131425
What you commit to
- Study type: Interventional
- Participants enrolled: 73
- From 1 Sept 2021 to the primary completion date, 31 Aug 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- A primary mental health diagnosis of a non-anxiety psychiatric condition such as a thought disorder, as determined following administration of the ADIS:ASA, thus suggesting that a different treatment approach is merited
Age
- A raw score above 18 on the Irritability sub-scale of the Aberrant Behavior Checklist-Community (ABC-C), indicating problem behavior is 1.5-2 SD above the mean for youth with ID within this age range, thus suggesting a group treatment may not be appropriate
Other
- Inability of families to attend at least 11 of 14 sessions
Who the study is looking for
- Chronological age between 12-18 years
- A confirmed diagnosis of ASD, as based on a score above ASD cutoff on the Autism Diagnostic Observation Schedule-Second Edition and DSM-5 clinical evaluation
- Cognitive and adaptive behavior abilities in the ID range as determined by a Brief IQ standard score between 40 - 70 on the Stanford Binet-Fifth Edition (SB-5) and a Total Adaptive Composite below 70 on the Adaptive Behavior Assessment System, 3rd Edition (ABAS-3)
- Clinically significant symptoms of anxiety, defined by clinically significant anxiety elevations on the ADAMS and meeting diagnostic criteria for at least one anxiety diagnosis on the Anxiety Disorders Interview Schedule: Autism Addendum (ADIS:ASA)
Age in the registry: 12 years to 18 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| University of Colorado Anschutz Medical Campus Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.