Administering a Parent-based Pilot Intervention for Reducing Anxiety in Children With ASD and Anxiety
Primary Purpose
ASD, Anxiety
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
SPACE
Sponsored by
About this trial
This is an interventional other trial for ASD, Anxiety
Eligibility Criteria
Inclusion Criteria ASD Anxiety Symptoms
Exclusion Criteria:
- Anxiety treatment
Sites / Locations
- Hebrew universityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SPACE INTERVENTION
Arm Description
counseling
Outcomes
Primary Outcome Measures
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.
Family Accommodation Scale - Anxiety (FASA)
study accommodation across childhood anxiety disorders.
Secondary Outcome Measures
Full Information
NCT ID
NCT04747262
First Posted
February 6, 2021
Last Updated
February 6, 2021
Sponsor
Hebrew University of Jerusalem
1. Study Identification
Unique Protocol Identification Number
NCT04747262
Brief Title
Administering a Parent-based Pilot Intervention for Reducing Anxiety in Children With ASD and Anxiety
Official Title
Administering a Parent-based Pilot Intervention- SPACE for Reducing Anxiety in Children With ASD
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 17, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hebrew University of Jerusalem
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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..
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ASD, Anxiety
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SPACE INTERVENTION
Arm Type
Experimental
Arm Description
counseling
Intervention Type
Behavioral
Intervention Name(s)
SPACE
Intervention Description
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)
Primary Outcome Measure Information:
Title
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).
Description
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.
Time Frame
15 minutres
Title
Family Accommodation Scale - Anxiety (FASA)
Description
study accommodation across childhood anxiety disorders.
Time Frame
15 minutres
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria ASD Anxiety Symptoms
Exclusion Criteria:
Anxiety treatment
Facility Information:
Facility Name
Hebrew university
City
Jerusalem
ZIP/Postal Code
5290002
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ANALIA SHEFER, Ph.d
Phone
972507717627
Email
analia.shefer@mail.hujai.ac.il
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Administering a Parent-based Pilot Intervention for Reducing Anxiety in Children With ASD and Anxiety
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