Cognitive Behavioral Therapy + Psychoeducation for Anxiety in Children With Autism

Overseen By Belina Onomake

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Disqualifiers: Non-English, Foster care, Severe behavior, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 14 weeks

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a new telehealth program, DINOSAUR (DINO Strategies for Anxiety and Intolerance of Uncertainty Reduction), in helping young children with autism manage anxiety. The program employs cognitive-behavioral therapy (CBT) techniques to teach both children and their parents strategies for reducing anxiety and better handling uncertainty. Suitable participants are children aged 4 to 6, diagnosed with autism, and experiencing frequent anxiety. The trial will compare the full program to a group where parents receive educational sessions about anxiety and autism. As an unphased trial, this study provides families with a unique opportunity to access innovative support strategies for managing anxiety in young children with autism.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this intervention is safe for young autistic children?

Research has shown that cognitive-behavioral therapy (CBT) is generally safe for children with autism. Studies indicate that when adapted for autistic children, CBT can reduce anxiety without causing significant side effects.

For the DINOSAUR intervention specifically, direct data remains limited. However, as a version of CBT, it is reasonable to expect similar safety. Therapies like CBT generally lack the side effect risks associated with medications, making them usually safe for children, including those with autism.

Although direct evidence on DINOSAUR is not yet available, the widespread use and safety of CBT suggest that this program is likely safe as well.

Why are researchers excited about this trial?

Researchers are excited about the DINOSAUR treatment because it combines cognitive-behavioral therapy (CBT) with psychoeducation in a unique way, tailored specifically for children with autism. Unlike typical anxiety treatments that may rely heavily on medication or in-person therapy sessions, DINOSAUR is delivered via telehealth, making it more accessible for families. This approach not only empowers parents by teaching them strategies to manage their child's anxiety but also directly involves the child, helping both to tackle anxiety's root causes together.

What evidence suggests that DINOSAUR could be an effective treatment for anxiety in young children with autism?

Research has shown that cognitive-behavioral therapy (CBT), when specially adapted for children with autism, effectively reduces anxiety in school-age autistic children. This therapy is promising because it addresses intolerance of uncertainty (IU), a factor that can lead to anxiety. Early findings suggest that CBT helps manage anxiety by teaching children coping strategies. This trial tests the DINOSAUR program, a new online CBT intervention designed to reduce both anxiety and IU in young autistic children. Although specific data on DINOSAUR is limited, it is based on proven CBT methods for autism, indicating potential benefits.

Are You a Good Fit for This Trial?

This trial is for young children aged 4 to nearly 7 with autism who also show signs of anxiety. They should not have other neurological or genetic conditions, and must be able to communicate in basic English. A parent must join them for a 14-week online therapy program.

Inclusion Criteria

I am between 4 and 6 years old.

My language skills are at or above a 3-year-old level according to the TELD-4 test.

My caregiver can attend a 14-week program with me.

Exclusion Criteria

Participating parent experiencing active symptoms of substance abuse or severe mental illness (i.e., schizophrenia, bipolar disorder)

Child is in foster care

Child displays severe behavior challenges that prevent participation in treatment groups (i.e., severe tantrums, aggression, or self-injury)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the DINOSAUR intervention or active control over 14 weeks via telehealth

14 weeks

Telehealth sessions

Follow-up

Participants are monitored for changes in anxiety and intolerance of uncertainty at 4-month follow-up

4 months

What Are the Treatments Tested in This Trial?

Interventions

• DINOSAUR

Trial Overview The DINO RCT is testing a new telehealth cognitive-behavioral therapy called DINOSAUR, designed specifically for autistic children with anxiety. It aims to reduce their anxiety and intolerance of uncertainty over the course of the study.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Parent-child dyads will receive DINOSAUR, a group-based cognitive-behavioral therapy (CBT) intervention, adapted for young children and delivered via telehealth. This 14 week intervention teaches parents and children strategies to reduce anxiety and intolerance of uncertainty, an underlying construct of anxiety.

Group II: Active Control Active Control 1 Intervention

Parents in the active control condition will participate in three psychoeducational groups focused on presenting information regarding anxiety prevalence, differentiating anxiety from autism, and anxiety triggers. These groups will be delivered via telehealth across a 14-week period.

Who Is Running the Clinical Trial?

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Lead Sponsor

Trials

93

Recruited

25,200+

Published Research Related to This Trial

In a study involving 870 children with autism spectrum disorder, nearly half of the reported anxieties were unique to autism, such as sensory sensitivities and fears of change, highlighting the need to recognize these 'autism-related' anxieties alongside common anxiety disorders.

Caregivers of children with more severe autism symptoms reported a greater prevalence of autism-related anxieties, suggesting that anxiety experiences may vary significantly based on the severity of autism traits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anxiety in young people with autism spectrum disorder: Common and autism-related anxiety experiences and their associations with individual characteristics. Lau, BY., Leong, R., Uljarevic, M., et al.[2021]

The CUES intervention program, designed to help children with autism spectrum disorder (ASD) manage anxiety related to uncertainty, is being evaluated for its acceptability and feasibility among parents, with 60 participants involved in a pilot randomized controlled trial.

This study aims to gather insights on the effectiveness of CUES compared to standard emotional support services, which will help shape a larger trial in the future, ensuring that the intervention meets the needs of families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coping with Uncertainty in Everyday Situations (CUES©) to address intolerance of uncertainty in autistic children: study protocol for an intervention feasibility trial. Rodgers, J., Goodwin, J., Parr, JR., et al.[2023]

Autistic children show significantly higher levels of intolerance of uncertainty (IU) symptoms across all domains (affective, behavioral, and cognitive) compared to neurotypical (NT) peers, with affective symptoms being the most strongly associated with autism.

Among autistic children, those with anxiety demonstrate even greater IU symptoms in all domains, particularly in behavioral symptoms, highlighting the need for tailored assessment and treatment strategies that consider IU profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the Symptom Profiles of Intolerance of Uncertainty in Autistic Children. Keefer, A., Singh, V., Jang, YS., et al.[2023]

Modified cognitive-behavioral therapy (MCBT) significantly reduced anxiety in 43 children with autism spectrum disorder (ASD), as reported by their parents.

Higher levels of intolerance of uncertainty (IU) before treatment were linked to greater anxiety and worry both before and after MCBT, suggesting that addressing IU could enhance treatment outcomes for youth with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intolerance of Uncertainty Predicts Anxiety Outcomes Following CBT in Youth with ASD. Keefer, A., Kreiser, NL., Singh, V., et al.[2022]

The Facing Your Fears: School-Based program (FYF-SB) effectively adapted cognitive behavioral therapy (CBT) for students with autism spectrum disorder (ASD), showing significant improvements in anxiety symptoms across multiple areas after the intervention.

Students benefited from CBT delivered by interdisciplinary school providers, with reductions in anxiety observed even in areas not directly targeted by the program, indicating potential for broader impacts on their overall functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From Clinic to Classroom: Two Case Studies of Youth With ASD and Anxiety From the School-Based Facing Your Fears Program. Rosen, TE., Pickard, K., Ponomaryova, A., et al.[2022]

A study involving 49 children with Autism Spectrum Disorder (ASD) showed that Cognitive Behavioural Therapy (CBT) significantly reduced anxiety, with 30% of participants free from their primary anxiety diagnoses after treatment.

While there were no significant differences in primary outcomes between the treatment and waitlist groups, secondary outcomes indicated meaningful improvements, suggesting that CBT is a feasible and potentially effective intervention for anxiety in children with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group Based Cognitive Behavioural Therapy for Anxiety in Children with Autism Spectrum Disorder: A Randomised Controlled Trial in a General Child Psychiatric Hospital Setting. Kilburn, TR., Sørensen, MJ., Thastum, M., et al.[2023]

Cognitive Behavioral Therapy (CBT) is effective in reducing anxiety symptoms in children with Autism Spectrum Disorder (ASD), showing a moderate effect size of -0.66 based on a meta-analysis of 23 studies.

Involving parents in the treatment process significantly enhances the effectiveness of CBT, with a larger effect size of -0.85 compared to child-only treatments, which had a smaller effect size of -0.34.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Cognitive Behavioral Therapy for Reducing Anxiety in Children with High Functioning ASD: A Systematic Review and Meta-Analysis. Perihan, C., Burke, M., Bowman-Perrott, L., et al.[2020]

A new parent group-based treatment program focusing on intolerance of uncertainty (IU) was developed and delivered to 11 parents of young people with autism spectrum disorders (ASD), showing positive feedback on its retention, acceptability, and feasibility.

Effect size analyses suggest that this program may be a promising treatment option for addressing anxiety related to IU in children with ASD, warranting further investigation in larger trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Towards a Treatment for Intolerance of Uncertainty in Young People with Autism Spectrum Disorder: Development of the Coping with Uncertainty in Everyday Situations (CUES©) Programme. Rodgers, J., Hodgson, A., Shields, K., et al.[2022]

The pilot study of the CUES© intervention involved 50 autistic children, with 72% of those in the CUES© group attending 4-8 sessions, indicating good feasibility and acceptability of the program.

Parents and therapists reported that CUES© was useful, suggesting it may effectively help autistic children cope with anxiety related to uncertainty, warranting further evaluation in a larger randomized controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coping with uncertainty in everyday situations (CUES©) to address intolerance of uncertainty in autistic children: an intervention feasibility trial. Rodgers, J., Goodwin, J., Garland, D., et al.[2023]

Citations