Administering a Parent-based Pilot Intervention for Reducing Anxiety in Children With ASD and Anxiety

Not Applicable

• Conditions: ASD, Anxiety
• Interventions: Behavioral: SPACE

• Registration Number: NCT04747262
• Lead Sponsor: Hebrew University of Jerusalem

Brief Summary

We are implementing the SPACE program, an evidence-based protocol that has been proven to be efficent in childhood anxiety disorders and OCD (Lebowitz, 2013; Lebowitz, Omer, Hermes \& Scahill, 2014), in a new population of children with ASD and anxiety. The intervention aims to reduce family accommodation of the child's anxiety symptoms. The program contains 12 weekly 1-hour sessions with the parents. We will examine the impact of the intervention on family accommodation, ASD and anxiety symptomology, as well as parent and child satisfaction from the intervention, using the attached measures.

Detailed Description

Participants are parents of children with ASD and anxiety between the ages of 6-10.

We will recruit 30 families. Recruitment takes place through social media, the Autism Center of Hebrew University, lab contacts and community partnerships. Participants are parents of young children between the ages of 6-10, where the child has a recognized diagnosis of ASD by Ministry of Health, Social Security or Ministry of Education, average (or above) cognition as per parent report and communication as measured by ABAS, and anxiety as measured by SCARED. Parents of children who have other relevant neurological or medical conditions will be excluded. Participants will be asked to provide a copy of the latest diagnosis prior to participation. Measures (attached) will be administered prior to the intervention, at the conclusion and again 2 months later. Participants will complete questionnaires online (Qualtrics). Treatment sessions will be held on ZOOM and certain sessions will be taped for supervision purposes.

The program is designed to reduce child anxiety symptoms, parent stress and family accommodation. Parents are likely to gain important skills and experience an increase in feelings of self-efficacy. The SPACE program is parent-based and is applicable in cases where children are not cooperative, and if proven to be effective in the ASD population, could serve not only as an alternative treatment but also as a primary intervention in the context of ASD..

Study Timeline

• Study Start: 2021-01-17
• Status Verified: 2021-02
• Study First Submitted: 2021-02-06
• Study First Submitted QC: 2021-02-06
• Last Update Submitted: 2021-02-06
• Study First Posted: 2021-02-10
• Last Update Posted: 2021-02-10
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

• Anxiety treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SPACE INTERVENTION	SPACE	counseling

Primary Outcome Measures

Name	Time	Method
The psychometric properties of the Screen for Child Anxiety Related Disorders (SCARED) are discussed in Birmaher, B., Brent, D. A., Chiappetta, L., Bridge, J., Monga, S., & Baugher, M. (1999).	15 minutres	The Screen for Child Anxiety Related Disorders (SCARED) is a 41-item inventory rated on a 3 point Likert-type scale. It comes in two versions; one asks questions to parents about their child and the other asks these same questions to the child directly. The purpose of the instrument is to screen for signs of anxiety disorders in children.
Family Accommodation Scale - Anxiety (FASA)	15 minutres	study accommodation across childhood anxiety disorders.

Trial Locations

Locations (1)

Hebrew university; 🇮🇱 Jerusalem, Israel