Cognitive Behavioral Therapy for Anxiety in Children with Autism and Intellectual Disability
(FYF Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a therapy program called Facing Your Fears, designed to help children with autism and intellectual disabilities manage anxiety. The study tests the effectiveness of this therapy for children aged 12-18 who have both autism and significant anxiety. Participants will attend weekly sessions with their parents over two 12-week cycles to learn coping strategies. Children with autism who frequently experience anxiety symptoms might be a good fit for this trial. As an unphased trial, this study offers a unique opportunity for participants to contribute to developing effective anxiety management strategies for children with autism.
Do I need to stop my current medications to join the trial?
You don't need to stop your current medications to join the trial, but they must be stable for at least 8 weeks before starting. You also can't start any new anxiety treatments during the 12-week study period.
What prior data suggests that the Facing Your Fears intervention is safe for children with ASD and intellectual disability?
Research has shown that the Facing Your Fears program is generally well-received by children with autism. In various studies, children and teens with autism who participated in the program experienced noticeable reductions in anxiety. For instance, one study with 49 children found that Cognitive Behavioral Therapy (CBT) reduced anxiety in about 30% of them. Importantly, no major negative effects were reported, indicating that children managed the therapy well.
These studies suggest that the Facing Your Fears program is safe and can help reduce anxiety in children with autism. Although limited research exists specifically on children with both autism and intellectual disabilities, the existing evidence supports the program's safety in similar groups.12345Why are researchers excited about this trial?
Researchers are excited about the Facing Your Fears treatment because it adapts cognitive behavioral therapy (CBT) specifically for children with autism spectrum disorder (ASD) and intellectual disability, a group often underserved by standard anxiety treatments. While typical CBT approaches focus on emotional regulation and cognitive tools, this treatment fine-tunes those strategies to fit the unique sensory and regulatory profiles of these children. It also emphasizes gradual exposure to anxiety-inducing situations, providing a supportive and tailored environment for each child's needs. This specialized approach aims to offer more effective anxiety management for children who might not benefit from conventional methods.
What evidence suggests that the Facing Your Fears program might be an effective treatment for anxiety in children with autism and intellectual disability?
Research has shown that the Facing Your Fears (FYF) program, which participants in this trial may receive, helps reduce anxiety in autistic children and teens. Studies have found that participants experience a noticeable drop in anxiety levels after completing the FYF program. This program is especially helpful for autistic youth with anxiety disorders. FYF uses a form of therapy called cognitive-behavioral therapy (CBT) adapted for them. It teaches skills like managing emotions, thinking positively, and coping with stress. These skills help children deal with anxiety more effectively.13678
Are You a Good Fit for This Trial?
This trial is for children aged 12-18 with Autism Spectrum Disorder (ASD) and Intellectual Disability (ID), who also experience anxiety. They must meet the DSM-V criteria for ASD. The study seeks parent-child dyads, implying active parental involvement.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the Facing Your Fears CBT intervention for anxiety in children with ASD and intellectual disability
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Facing Your Fears
Trial Overview
The 'Facing Your Fears' program, a cognitive behavioral therapy designed for children with autism to address anxiety, is being tested over two 12-week cycles involving weekly in-person sessions that include both education and practice of strategies.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
A wait-list control design is employed to ethically evaluate the impact of a CBT intervention. Participants are initially screening using a comprehensive battery of standardized assessments to establish baseline functioning. The assessments include the SCARED/ MASC-2 to evaluate anxiety symptoms; CBCL to evaluate emotional behavioral problems; PedsQL to measure health-related quality of life; ADOS to support diagnostic clarity for autism spectrum characteristics; and the WASI to assess cognitive function and IQ. Following this pre-intervention phase, participants enter a wait-list control period where they do not receive the CBT intervention. The waiting period serves as the control condition, providing natural comparison for later outcomes. Once their cycle is assigned, the same participants transition into the experimental phase.
The experimental condition is a cognitive behavioral therapy intervention that is typically geared for children with ASD without intellectual disability. The established CBT, Facing Your Fears, supports participants in the following key areas: 1) building emotional regulation, 2) developing cognitive tools such as positive self-talk and affirmations, 3) enhancing coping strategies adapted to individual sensory and regulatory profiles, and 4) engaging in gradual exposure to situations or stimuli. The experimental condition will apply the Facing Your Fears model to children with ASD and intellectual disability.
Find a Clinic Near You
Who Is Running the Clinical Trial?
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead Sponsor
Citations
A Cognitive Behavioral Therapy Approach to Addressing ...
This pilot study aims at addressing and treating anxiety in children with ASD and intellectual disability through the Facing Your Fears (FYF) ...
Facing Your Fears in Adolescence: Cognitive-Behavioral ...
The purpose of the present study was to develop an intervention for treating anxiety in adolescents with ASD based on a CBT program designed for school-aged ...
Facing Your Fears in autistic youth with co-occurring ...
Adapted cognitive-behavioural interventions, such as Facing Your Fears (FYF), are effective in reducing anxiety in autistic youth.
4.
medschool.cuanschutz.edu
medschool.cuanschutz.edu/jfk-partners/clinical-services/facing-your-fears-program/research--evidence-base--and-publicationsResearch, Evidence Base, and Publications
The results of all six studies indicated that autistic children and teens demonstrated significant reductions in anxiety following participation in FYF. A ...
Cognitive behavioral therapy for anxiety in children with ...
This study is a randomized, controlled trial testing a modified cognitive behavior therapy (CBT) protocol for children with ASD and comorbid anxiety disorders.
Adolescents With ASD and Intellectual Disability
Preliminary results indicated significant improvements in anxiety and mood symptoms. The proposed study seeks to test whether FYF:ASD/ID is more ...
Telehealth delivery of cognitive-behavioral intervention to ...
This study details the pilot testing of a telehealth version of an empirically supported intervention targeting anxiety in youth with autism spectrum disorders.
Facing Your Fears Therapy for ASD with Intellectual Disability
A study involving 49 children with Autism Spectrum Disorder (ASD) showed that Cognitive Behavioural Therapy (CBT) significantly reduced anxiety, with 30% of ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.