Anxiety Intervention for Preschool Children With ASD

Overseen By Amy Keefer, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

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

Disqualifiers: Psychological trauma, Neurologic illness, Parent substance abuse, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

12 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 DINOSAUR treatment for anxiety and fear of uncertainty?

The research suggests that expert help and support from the home environment and fellow patients can reduce anxiety and uncertainty, which are key components of the DINOSAUR treatment. Additionally, specific communication strategies, like one-on-one announcements, have been shown to decrease anxiety in patients undergoing medical procedures. ^{1 2 3 4 5}

How does the DINOSAUR treatment for anxiety differ from other treatments?

The DINOSAUR treatment is unique because it specifically targets intolerance of uncertainty (IU), which is a key factor in maintaining anxiety. Unlike other treatments, it focuses on helping individuals with high IU better manage their fear and anxiety by addressing their response to uncertain situations, potentially improving threat extinction and reducing anxiety symptoms. ^{6 7 8 9 10}

What is the purpose of this trial?

This trial tests a new program called DINOSAUR, which helps young children with autism manage anxiety. The program uses a special type of therapy that teaches kids and their parents ways to reduce anxiety and handle fears. It focuses on making both children and parents more comfortable with uncertainty. DINOSAUR is a program for 4- to 6-year-old children with autism, combining different therapeutic techniques to help both children and parents.

Eligibility Criteria

Inclusion Criteria

DSM-5 diagnoses of Separation Anxiety, Social Anxiety, and/or Generalized Anxiety Disorder and/or the distinct diagnosis of Other Social Fear based on the results of the Anxiety Disorders Interview Schedule/ASA

Age 4 years 0 months to 6 years 11 months

NVIQ ≥ 85 based on Mullen Scales of Early Learning or Stanford Binet 5

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Waitlist

Participants are placed on a 12-week waitlist before starting the intervention

12 weeks

Treatment

Participants receive the DINOSAUR intervention, a CBT program modified for young children with ASD

12 weeks

Follow-up

Participants are monitored for changes in anxiety and ASD symptoms after treatment

4 weeks

Treatment Details

Interventions

• DINO Strategies for Anxiety and fear of Uncertainty Reduction (DINOSAUR)

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

All participants receive the DINOSAUR intervention

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

93

Recruited

25,200+

Organization for Autism Research

Collaborator

Trials

7

Recruited

110+

References

1. Ireland pubmed.ncbi.nlm.nih.gov

How should uncertainty about upcoming painful procedures be communicated? An experimental study into highly uncertain pain predictions. [2023]

2. Ireland pubmed.ncbi.nlm.nih.gov

Is anxiety a suitable measure of decision aid effectiveness: a systematic review? [2019]

3. England pubmed.ncbi.nlm.nih.gov

The significance of the doctor-patient relationship in coping with cancer. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Anxiety during Radiation Therapy: A Prospective Randomized Controlled Trial Evaluating a Specific One-on-One Procedure Announcement Provided by a Radiation Therapist. [2021]

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

Disclosing the Uncertainty Associated with Prognostic Estimates in Breast Cancer. [2018]

6. Netherlands pubmed.ncbi.nlm.nih.gov

The role of intolerance of uncertainty in classical threat conditioning: Recent developments and directions for future research. [2021]

7. England pubmed.ncbi.nlm.nih.gov

I feel safe when i know: Contingency instruction promotes threat extinction in high intolerance of uncertainty individuals. [2020]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Your guess is as good as mine: A registered report assessing physiological markers of fear and anxiety to the unknown in individuals with varying levels of intolerance of uncertainty. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

The role of threat level and intolerance of uncertainty in extinction. [2020]

10. England pubmed.ncbi.nlm.nih.gov

The Role of Threat Level and Intolerance of Uncertainty (IU) in Anxiety: An Experimental Test of IU Theory. [2018]