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

Trial Summary

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 data supports the effectiveness of the treatment DINOSAUR, DINO Strategies for Anxiety and Intolerance of Uncertainty Reduction for anxiety in children with autism?

Research shows that modified cognitive-behavioral therapy (MCBT) can reduce anxiety in children with autism, and targeting intolerance of uncertainty (IU) may improve outcomes. Additionally, a program focusing on IU has shown promise as a treatment option for young people with autism and anxiety. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy + Psychoeducation for Anxiety in Children With Autism safe?

The studies suggest that the treatment, which includes strategies like the CUES program, is generally well-received by parents and shows promise as a treatment option, indicating it is likely safe for children with autism and anxiety. ^{1 2 3 4 6}

How is the DINOSAUR treatment different from other treatments for anxiety in children with autism?

The DINOSAUR treatment is unique because it combines cognitive behavioral therapy (CBT) with psychoeducation specifically targeting intolerance of uncertainty, which is a significant factor in anxiety for children with autism. This approach aims to improve outcomes by addressing a key anxiety trigger that is often not the focus of standard CBT treatments. ^{1 3 7 8 9}

What is the purpose of this trial?

Anxiety is prevalent in young children, under 7 years of age, with autism. Yet, few studies have examined anxiety interventions for this age range, and only one anxiety treatment study has included young children with cognitive and language delays. Anxiety treatment models utilizing cognitive-behavioral therapy (CBT), adapted for children with autism, are empirically supported in school-age autistic children. Further, preliminary evidence suggests CBT approaches may reduce intolerance of uncertainty (IU), a mechanistic construct that may contribute to the maintenance of anxiety in autistic children. This study seeks to address the existing gap in anxiety treatment by examining the feasibility and preliminary efficacy of a novel, telehealth CBT intervention, DINO Strategies for Anxiety and intolerance of Uncertainty Reduction (DINOSAUR), which targets both anxiety and IU in young autistic children.

Eligibility Criteria

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

Child is in foster care

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Intolerance of Uncertainty Predicts Anxiety Outcomes Following CBT in Youth with ASD. [2022]

2. United States 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. [2022]

3. England 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. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Coping with uncertainty in everyday situations (CUES©) to address intolerance of uncertainty in autistic children: an intervention feasibility trial. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Exploring the Symptom Profiles of Intolerance of Uncertainty in Autistic Children. [2023]

6. England 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. [2023]

7. United States 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. [2022]

8. United States 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. [2023]

9. United States 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. [2020]