Facing Your Fears: Adolescents With ASD and Intellectual Disability

NCT05131425 | Active Not Recruiting

• 1 other identifier: 20-3142
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

autism spectrum disorder; intellectual disability; cognitive behavioral therapy; anxiety; emotion regulation

Outcome Measures

Primary Outcomes (2)

• Change in number of anxiety diagnoses as measured by the Anxiety Disorders Interview Schedule: Autism Addendum (ADIS:ASA)

  The ADIS:ASA is a semi-structured clinical interview completed with a parent that assesses anxiety diagnoses in children and adolescents with ASD. This measure provides a total number of anxiety diagnoses for a child. The interview will be administered and anxiety diagnoses recorded at the following time points: Baseline (i.e., within 6 weeks' start of the treatment or TA condition), Post treatment (i.e., within 6 weeks of the completion of the14-week treatment or TAU condition), and follow-up (six months following the completion of the treatment condition). Change in the total number of anxiety diagnoses that a child meets diagnostic criteria for on the ADIS:ASA will be calculated across the aforementioned time points.

  Baseline (i.e., within 6 weeks' start of the treatment or TAU condition), Post treatment (i.e., within 6 weeks of the completion of the14-week treatment or TAU condition), and follow-up (six months following the completion of the treatment condition)

• Change in the Clinical Global Improvement-Severity score as derived by the Anxiety Disorders Interview Schedule: Autism Addendum (ADIS:ASA)

  Clinical Global Improvement-severity (CGI-S) scores are derived from the ADIS:ASA. The CGI-S is a summary rating (i.e., likert scale of 1 to 7 with 7 indicating very severe) indicating the extent to which the teen's anxiety symptoms assessed via the ADIS:ASA impact daily functioning. To calculate change in anxiety severity, the CGI-S ratings are calculated at baseline (i.e., 6 weeks prior to the start of the 14-week TAU condition of intervention condition), post-treatment (i.e., within 6 weeks of the end of the completion of the 14-week TAU condition and intervention group conditions) and at follow-up (i.e., 6 months following the completion of the 14-week TAU intervention group). Change in CGI-S ratings across these time points are calculated.

  Baseline (i.e., within 6 weeks' start of the treatment or TAU condition), Post treatment (i.e., within 6 weeks of the completion of the14-week treatment or TAU condition), and follow-up (six months following the completion of the treatment condition)

Secondary Outcomes (3)

• Change in the Reactivity subscale as assessed by the Emotion Dysregulation Inventory (EDI)

  Baseline (i.e., within 6 weeks' start of the treatment or TAU condition), Post treatment (i.e., within 6 weeks of the completion of the14-week treatment or TAU condition), and follow-up (six months following the completion of the treatment condition)

• Change in the Dysphoria subscale as assessed by the Emotion Dysregulation Inventory (EDI)

  Baseline (i.e., within 6 weeks' start of the treatment or TAU condition), Post treatment (i.e., within 6 weeks of the completion of the14-week treatment or TAU condition), and follow-up (six months following the completion of the treatment condition)

• Change in problem behavior as assessed by the The Aberrant Behavior Checklist-Community (ABC-C)

  Baseline (i.e., within 6 weeks' start of the treatment or TAU condition), Post treatment (i.e., within 6 weeks of the completion of the14-week treatment or TAU condition), and follow-up (six months following the completion of the treatment condition)

Other Outcomes (1)

• Exploratory Aim: Exploratory analyses will be conducted to evaluate the effect of treatment participation on teens' independent use of somatic management, emotion regulation, and cognitive strategies using goal attainment scaling (e.g., GAS)

  Baseline (i.e., within 6 weeks' start of the treatment or TAU condition), Post treatment (i.e., within 6 weeks of the completion of the14-week treatment or TAU condition), and follow-up (six months following the completion of the treatment condition)

Study Arms (2)

Cognitive Behavioral Intervention

EXPERIMENTAL

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).

Behavioral: Facing Your Fears: ASD/ID

Treatment as Usual

OTHER

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.

Other: Treatment as Usual

Interventions

Facing Your Fears: ASD/ID BEHAVIORAL

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.

Also known as: Cognitive behavioral therapy

Cognitive Behavioral Intervention

Treatment as Usual OTHER

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.

Treatment as Usual

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• United States Department of Defense: collaborator

Study Sites (2)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (10)

• Blakeley-Smith A, Meyer AT, Boles RE, Reaven J. Group Cognitive Behavioural Treatment for Anxiety in Autistic Adolescents with Intellectual Disability: A Pilot and Feasibility Study. J Appl Res Intellect Disabil. 2021 May;34(3):777-788. doi: 10.1111/jar.12854. Epub 2021 Jan 6.

  PMID: 33410240 BACKGROUND

• Bakken TL, Helverschou SB, Eilertsen DE, Heggelund T, Myrbakk E, Martinsen H. Psychiatric disorders in adolescents and adults with autism and intellectual disability: a representative study in one county in Norway. Res Dev Disabil. 2010 Nov-Dec;31(6):1669-77. doi: 10.1016/j.ridd.2010.04.009. Epub 2010 May 20.

  PMID: 20493660 BACKGROUND

• Moskowitz LJ, Mulder E, Walsh CE, McLaughlin DM, Zarcone JR, Proudfit GH, Carr EG. A multimethod assessment of anxiety and problem behavior in children with autism spectrum disorders and intellectual disability. Am J Intellect Dev Disabil. 2013 Nov;118(6):419-34. doi: 10.1352/1944.7558.118.6.419.

  PMID: 24432856 BACKGROUND

• Sandjojo J, Gebhardt WA, Zedlitz AMEE, Hoekman J, Dusseldorp E, den Haan JA, Evers AWM. Development of the Leiden Independence Questionnaire for Support Staff: a measure of staff behaviour regarding promoting independence of people with intellectual disabilities. J Intellect Disabil Res. 2019 Apr;63(4):286-297. doi: 10.1111/jir.12574. Epub 2018 Dec 5.

  PMID: 30515912 BACKGROUND

• O'Nions E, Happe F, Evers K, Boonen H, Noens I. How do Parents Manage Irritability, Challenging Behaviour, Non-Compliance and Anxiety in Children with Autism Spectrum Disorders? A Meta-Synthesis. J Autism Dev Disord. 2018 Apr;48(4):1272-1286. doi: 10.1007/s10803-017-3361-4.

  PMID: 29222612 BACKGROUND

• Reaven J, Blakeley-Smith A, Nichols S, & Hepburn, S. (2011). Facing Your Fears: Group Therapy for Managing Anxiety in Children with High-Functioning Autism Spectrum Disorders. Baltimore, MD: Paul Brookes Publishing

  BACKGROUND

• Hurlbutt K, Chalmers L. Employment and Adults With Asperger Syndrome. Focus on Autism and Other Developmental Disabilities. 2004;19(4):215-222. doi:10.1177/10883576040190040301

  BACKGROUND

• Aman MG, Singh NN, Stewart AW, Field CJ. The aberrant behavior checklist: a behavior rating scale for the assessment of treatment effects. Am J Ment Defic. 1985 Mar;89(5):485-91.

  PMID: 3993694 BACKGROUND

• Esbensen AJ, Rojahn J, Aman MG, Ruedrich S. Reliability and validity of an assessment instrument for anxiety, depression, and mood among individuals with mental retardation. J Autism Dev Disord. 2003 Dec;33(6):617-29. doi: 10.1023/b:jadd.0000005999.27178.55.

  PMID: 14714931 BACKGROUND

• Vereenooghe L, Flynn S, Hastings RP, Adams D, Chauhan U, Cooper SA, Gore N, Hatton C, Hood K, Jahoda A, Langdon PE, McNamara R, Oliver C, Roy A, Totsika V, Waite J. Interventions for mental health problems in children and adults with severe intellectual disabilities: a systematic review. BMJ Open. 2018 Jun 19;8(6):e021911. doi: 10.1136/bmjopen-2018-021911.

  PMID: 29921688 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Intellectual Disability; Anxiety Disorders; Emotional Regulation

Interventions

Cognitive Behavioral Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Self-Control; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Audrey D Blakeley-Smith, Ph.d.

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A blinded clinical evaluator will assess outcome
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: November 23, 2021
• Study Start: September 1, 2021
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2025
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)