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

ASD, Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04747262
• Other study ID #: School of Education /SPACE
• Status: Recruiting
• Phase: N/A
• Start date: January 17, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2021
• Source: Hebrew University of Jerusalem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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..

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 10 Years

Eligibility

Inclusion Criteria ASD Anxiety Symptoms

Exclusion Criteria:

• Anxiety treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• ASD, Anxiety

Intervention

Behavioral:
• SPACE
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)

Locations

Country	Name	City	State
Israel	Hebrew university	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hebrew University of Jerusalem

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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.	15 minutres
Primary	Family Accommodation Scale - Anxiety (FASA)	study accommodation across childhood anxiety disorders.	15 minutres