Facing Your Fears: Adolescents With ASD and Intellectual Disability
Purpose
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
Eligibility
- Eligible Ages
- Between 12 Years and 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Chronological age between 12-18 years - A confirmed diagnosis of ASD, as based on a score above ASD cutoff on the Autism Diagnostic Observation Schedule-Second Edition and DSM-5 clinical evaluation - Cognitive and adaptive behavior abilities in the ID range as determined by a Brief IQ standard score between 40 - 70 on the Stanford Binet-Fifth Edition (SB-5) and a Total Adaptive Composite below 70 on the Adaptive Behavior Assessment System, 3rd Edition (ABAS-3) - Clinically significant symptoms of anxiety, defined by clinically significant anxiety elevations on the ADAMS and meeting diagnostic criteria for at least one anxiety diagnosis on the Anxiety Disorders Interview Schedule: Autism Addendum (ADIS:ASA)
Exclusion Criteria
- A primary mental health diagnosis of a non-anxiety psychiatric condition such as a thought disorder, as determined following administration of the ADIS:ASA, thus suggesting that a different treatment approach is merited - A raw score above 18 on the Irritability sub-scale of the Aberrant Behavior Checklist-Community (ABC-C), indicating problem behavior is 1.5-2 SD above the mean for youth with ID within this age range, thus suggesting a group treatment may not be appropriate - Inability of families to attend at least 11 of 14 sessions
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Intervention Model Description
- The main objective of the current proposal is to conduct an RCT (i.e., treatment group and treatment-as-usual (TAU) control group) to examine the impact of a cognitive behavioral treatment for anxiety in an adolescent sample of Autistic youth with intellectual disability. This clinical trial incorporates random assignment, a control group, and a treatment group. All participants in the TAU control group can crossover and complete the intervention.
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
- Masking Description
- A blinded clinical evaluator will assess outcome
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Cognitive Behavioral Intervention |
The experimental condition is a CBT intervention which focuses on developing 1) emotion regulation skills, 2) somatic management skills individually tailored for sensory and regulatory needs; 3) cognitive strategies such as individualized helpful thoughts and mantras (I can do it); and 4) graded exposure (e.g., facing fears). |
|
|
Other Treatment as Usual |
The TAU condition will serve as the control condition and participants' medication use and outside therapies will be tracked monthly. Following completion of the 16-week wait period, the TAU group will be invited to enroll in FYF:ASD/ID. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- University of Colorado, Denver
Detailed 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.
