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Active, not recruiting Not applicable Interventional Accepts healthy volunteers

Facing Your Fears: Adolescents With ASD and Intellectual Disability

ClinicalTrials.gov ID: NCT05131425

Public ClinicalTrials.gov record NCT05131425. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 9, 2026, 7:52 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Group Cognitive Behavioral Treatment for Anxiety in Adolescents With ASD and Intellectual Disability: A Randomized Controlled Trial

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05131425
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Not applicable
Enrollment
73 participants

Conditions and interventions

Eligibility (public fields only)

Age range
12 Years to 18 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 31, 2021
Primary completion
Aug 30, 2024
Completion
Aug 30, 2025
Last update posted
Jan 7, 2025

2021 – 2025

United States locations

U.S. sites
2
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
University of Colorado Anschutz Medical Campus Aurora Colorado 80045
University of Colorado Aurora Colorado 80045

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05131425, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 7, 2025 · Synced Sep 9, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05131425 live on ClinicalTrials.gov.

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