NCT04747262

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2021

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

2 years

First QC Date

February 6, 2021

Last Update Submit

February 6, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • Family Accommodation Scale - Anxiety (FASA)

    study accommodation across childhood anxiety disorders.

    15 minutres

Study Arms (1)

SPACE INTERVENTION

EXPERIMENTAL

counseling

Behavioral: SPACE

Interventions

SPACEBEHAVIORAL

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)

SPACE INTERVENTION

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may not qualify if:

  • Anxiety treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hebrew university

Jerusalem, 5290002, Israel

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D

Study Record Dates

First Submitted

February 6, 2021

First Posted

February 10, 2021

Study Start

January 17, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

February 10, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations