Facing Your Fears: Adolescents With ASD and Intellectual Disability
NCT05131425 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 73
Last updated 2025-01-08
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:ASD/ID.
Conditions
- Autism Spectrum Disorder
- Intellectual Disability
- Anxiety
- Emotion Regulation
Interventions
- BEHAVIORAL
-
Facing Your Fears: ASD/ID
This cognitive behavioral therapy, entitled Facing Your Fears for Adolescents with Autism and Intellectual Disability, is focused on somatic management, helpful cognitive mantras, emotion regulation, and graduated exposure adapted for the cognitive and linguistic needs of an Intellectual Disability population.
- OTHER
-
Treatment as Usual
The treatment as usual condition is being used in this study as a control condition. The investigators will track what medication and intervention services families are currently receiving.
Sponsors & Collaborators
-
United States Department of Defense
collaborator FED -
University of Colorado, Denver
lead OTHER
Principal Investigators
-
Audrey D Blakeley-Smith, Ph.d. · University of Colorado, Denver
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 12 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-09-01
- Primary Completion
- 2024-08-31
- Completion
- 2025-08-31
Countries
- United States
Study Locations
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