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Facing Your Fears: Adolescents With ASD and Intellectual Disability
NCT05131425 · View on ClinicalTrials.gov ↗
Study Summary
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
Conditions Studied
Interventions
- OTHER Treatment as Usual
- BEHAVIORAL Facing Your Fears: ASD/ID
Study Locations (2)
Colorado
- University of Colorado Anschutz Medical Campus — Aurora
- University of Colorado — Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2021-09-01 |
| Est. Completion | 2025-08-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05131425
The ClinicalTrials.gov registry entry for NCT05131425 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 73 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,447 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Anxiety appearing as the primary indexed condition, and to 2 interventions — of which Treatment as Usual is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05131425 reports 2 study locations spanning 1 distinct geographic area — top geographies include Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05131425 about?
NCT05131425 is a clinical study titled "Facing Your Fears: Adolescents With ASD and Intellectual Disability". 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 cop...
What is the current status of trial NCT05131425?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 73 participants. The study started on 2021-09-01. Estimated completion is 2025-08-31.
What conditions does trial NCT05131425 study?
This clinical trial studies the following conditions: Anxiety, Autism Spectrum Disorder, Intellectual Disability, Emotion Regulation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05131425?
The interventions under investigation include: Treatment as Usual (OTHER), Facing Your Fears: ASD/ID (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05131425?
This trial is sponsored by University of Colorado, Denver, which has 1,447 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05131425 being conducted?
This trial has 2 study locations across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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