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

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ClinicalTrials.gov Identifier: NCT04747262
Recruitment Status : Recruiting
First Posted : February 10, 2021
Last Update Posted : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
Analia Shefer, Hebrew University of Jerusalem

Study Description
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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.

Condition or disease Intervention/treatment Phase
ASD, Anxiety Behavioral: SPACE Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Other
Official Title: Administering a Parent-based Pilot Intervention- SPACE for Reducing Anxiety in Children With ASD
Actual Study Start Date : January 17, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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Arm Intervention/treatment
Experimental: SPACE INTERVENTION
counseling
 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)


Outcome Measures
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Primary Outcome Measures :
  1. 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). [ Time Frame: 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.

  2. Family Accommodation Scale - Anxiety (FASA) [ Time Frame: 15 minutres ]
    study accommodation across childhood anxiety disorders.


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria ASD Anxiety Symptoms

Exclusion Criteria:

  • Anxiety treatment
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04747262


Locations
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Israel
Hebrew university Recruiting
Jerusalem, Israel, 5290002
Contact: ANALIA SHEFER, Ph.d    972507717627    analia.shefer@mail.hujai.ac.il   
Sponsors and Collaborators
Hebrew University of Jerusalem
More Information
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Responsible Party: Analia Shefer, Ph.D, Hebrew University of Jerusalem
ClinicalTrials.gov Identifier: NCT04747262    
Other Study ID Numbers: School of Education /SPACE
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders