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

No results posted yet for this 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:ASD/ID.

Conditions

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05131425 on ClinicalTrials.gov