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

NCT ID: NCT04747262

Last Updated: 2021-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-17

Study Completion Date

2022-12-31

Brief Summary

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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

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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..

Conditions

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ASD, Anxiety

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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SPACE INTERVENTION

counseling

Group Type EXPERIMENTAL

SPACE

Intervention Type BEHAVIORAL

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)

Interventions

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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)

Intervention Type BEHAVIORAL

Eligibility Criteria

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Exclusion Criteria

* Anxiety treatment
Minimum Eligible Age

6 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hebrew University of Jerusalem

OTHER

Sponsor Role lead

Responsible Party

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Analia Shefer

Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hebrew university

Jerusalem, , Israel

Site Status RECRUITING

Countries

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Israel

Facility Contacts

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ANALIA SHEFER, Ph.d

Role: primary

972507717627

References

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Rozenblat S, Shimshoni Y, Lebowitz ER, Perez M, Koller J. A Pilot Trial of SPACE (Supportive Parenting for Anxious Childhood Emotions) in Autism. Child Psychiatry Hum Dev. 2025 Feb;56(1):249-263. doi: 10.1007/s10578-023-01555-4. Epub 2023 Jun 23.

Reference Type DERIVED
PMID: 37353645 (View on PubMed)

Other Identifiers

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School of Education /SPACE

Identifier Type: -

Identifier Source: org_study_id

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