Cognitive Behavioral Therapy for Anxiety in Children with Autism and Intellectual Disability

(FYF Trial)

Overseen By Kayleigh Tam, BA

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Disqualifiers: Suicidal ideations, Concurrent study, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

Duration: 12 weeks

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.

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. ^{1 2 3 4 5}

Why 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. ^{1 3 6 7 8}

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

ADOS scores consistent with an ASD diagnosis

WASI scores equivalent to 50-70

CBCL with T score >/= 70 for the anxiety subscale

Exclusion Criteria

Individuals involved in a concurrent interventional study

Individuals with history of significant suicidal ideations or attempts

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants receive the Facing Your Fears CBT intervention for anxiety in children with ASD and intellectual disability

12 weeks

12 visits (in-person, weekly)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

1 visit (in-person)

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?

Group I: Wait-List Control Experimental Treatment 1 Intervention

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.

Group II: Cognitive Behavioral Intervention Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07245160

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) ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3471403/

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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1750946724001387

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-publications

Research, 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 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4231198/

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.

6. trialx.com trialx.com/clinical-trials/listings/264849/facing-your-fears-adolescents-with-asd-and-intellectual-disability/

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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4615367/

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.

8. withpower.com withpower.com/trial/phase-autism-spectrum-disorder-8-2021-17396

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 ...