Facing Your Fears: Adolescents With ASD and Intellectual Disability

Last updated: January 6, 2025
Sponsor: University of Colorado, Denver
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Anxiety Disorders

Williams Syndrome

Asperger's Disorder

Treatment

Facing Your Fears: ASD/ID

Treatment as Usual

Clinical Study ID

NCT05131425
20-3142
  • Ages 12-18
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Chronological age between 12-18 years

  • A confirmed diagnosis of ASD, as based on a score above ASD cutoff on the AutismDiagnostic Observation Schedule-Second Edition and DSM-5 clinical evaluation

  • Cognitive and adaptive behavior abilities in the ID range as determined by a BriefIQ standard score between 40 - 70 on the Stanford Binet-Fifth Edition (SB-5) and aTotal Adaptive Composite below 70 on the Adaptive Behavior Assessment System, 3rdEdition (ABAS-3)

  • Clinically significant symptoms of anxiety, defined by clinically significantanxiety elevations on the ADAMS and meeting diagnostic criteria for at least oneanxiety diagnosis on the Anxiety Disorders Interview Schedule: Autism Addendum (ADIS:ASA)

Exclusion

Exclusion Criteria:

  • A primary mental health diagnosis of a non-anxiety psychiatric condition such as athought disorder, as determined following administration of the ADIS:ASA, thussuggesting that a different treatment approach is merited

  • A raw score above 18 on the Irritability sub-scale of the Aberrant BehaviorChecklist-Community (ABC-C), indicating problem behavior is 1.5-2 SD above the meanfor youth with ID within this age range, thus suggesting a group treatment may notbe appropriate

  • Inability of families to attend at least 11 of 14 sessions

Study Design

Total Participants: 73
Treatment Group(s): 2
Primary Treatment: Facing Your Fears: ASD/ID
Phase:
Study Start date:
September 01, 2021
Estimated Completion Date:
August 31, 2025

Study Description

Background: Adolescents with ASD and intellectual disability (ID) are a complex and under-served population. Anxiety occurs at higher rates in individuals with ASD/ID (53%) than in ID alone (17%) and may result in physical distress, avoidance of stressful situations, and problem behavior. Further, it frequently contributes to caregivers "taking over" tasks for youth with ID and limiting independence. Parents voice concern about treatment options as the limited available supports often focus on prevention and accommodation of anxiety, rather than on building coping skills. Thus, teens often finish high school with limited coping abilities and consequently experience heightened anxiety in the workplace and poor job retention. Yet, when coping skills are taught early in adolescence, there is an opportunity to practice coping prior to transition, leading to better employment rates, decreased clinical service use, and increased long-term wages. Addressing anxiety and building coping skills for teens with ASD/ID is of critical importance as these are per-requisite skills for successful transition to adulthood.

Intervention: A significant treatment barrier for teens with ASD/ID is the lack of evidence based, manualized interventions for this population. This is due, in part, because youth with ASD/ID have typically been excluded from intervention research trials examining the effectiveness of best practice treatments such as cognitive behavioral therapy (CBT). Recent research adapting CBT to meet the cognitive, social, and behavioral needs of this population have yielded promising results and challenge the paradigm that individuals with ID are not able to access cognitive and emotion regulation strategies. The research team for the present study adapted a CBT manualized intervention, Facing Your Fears, for adolescents with ASD/ID (FYF:ASD/ID) and completed a pilot study with 23 teens. Preliminary outcome measures indicated significant improvements in anxiety and mood symptoms.

Objective: The current study seeks to test whether FYF:ASD/ID, an adapted CBT intervention for teens with ASD/ID, is more effective in reducing anxiety than treatment-as-usual (TAU).

Study Design: The investigators will use 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.

Specific Aims: Three aims are proposed: (1) examine the efficacy of FYF: ASD/ID relative to TAU in improving anxiety as measured by parent report and determine if gains 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.

Impact: The present study would represent the first RCT of a CBT intervention for adolescents with ASD/ID, a critical step toward establishing an evidence base for anxiety treatment for this underserved and vulnerable population.

Translatability: It is necessary to close the gap in the availability of anxiety interventions and ensure effective mental health care for all individuals on the spectrum. Completing a well-designed RCT that incorporates random assignment, a control group, and careful measurement of anxiety is a critical next step in evaluating the effectiveness of this CBT treatment and supporting the study of interventions that can contribute to positive coping skills that allow teens to access time limited transition services and optimize outcome.

Connect with a study center

  • University of Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado 80045
    United States

    Site Not Available

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