Emotion Regulation in Preschoolers With Autism and Their Parents

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Meir Medical Center

ClinicalTrials.gov Identifier:

NCT01643720

First received: July 4, 2012

Last updated: August 9, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 4, 2012

Last Updated Date

August 9, 2012

Start Date ^ICMJE

November 2010

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Emotion regulation(ER)strategies during emotion eliciting episodes [ Time Frame: During a 2hr home visit, while the child interacts with the parent ] [ Designated as safety issue: No ]

The Frequency,duration and percentage of ER behaviors presented by the child and the parent will be coded microanalytically using computerized coding system: The Observer, Noldus Co., Waggeniggen, The Netherlands

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01643720 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Salivary hormone levels: Cortisol and Oxytocin of both parent and child [ Time Frame: collected 4 times during the assessment meeting, from both child and parent. ] [ Designated as safety issue: No ]

Changes in salivary Cortisol amd Oxytpcin levels over 3 time points during the home visit, before and after emotionally arousing activities. Collected from both parent and child.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Emotion Regulation in Preschoolers With Autism and Their Parents

Official Title ^ICMJE

Emotion Regulation in Preschoolers With Autism and Their Parents

Brief Summary

In the proposed study, the investigators would like to investigate the emotion regulation (ER) strategies children with Autism Spectrum Disorders (ASD) demonstrate, and the influence parents have on their children's ER. More specifically, the investigators would like to examine what are the ER mechanisms that parents use, what mechanisms of self regulation children with autism internalize, and how parents support and improve the ER capabilities of their child with ASD. These will be studied in a behavioral level, using micro-analysis of parent-child interaction, and in a physiological level, using indexes of stress control and affiliation. In addition, in order for parental ER support to be effective, it is important to consider more innate neuro-developmental difficulties children with ASD demonstrate that strongly affect their ability to regulate themselves. These include sensory regulation difficulties, temperament, attention disorders and poor executive functioning.

Hypotheses:

ER strategies used by children with ASD will be more poorly developed and less effective, compared to those of children in the control groups.
Difficult temperament and sensory regulation difficulties will hamper ER in children with ASD.
ER strategies of parents of children with ASD will be more poorly developed and less effective than those of parents in the control groups.
Good parental self-ER and parental attunement to the child will be predictive of improved ER in children with ASD, and in parent-child synchrony, both in the behavioral and in the physiological levels.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples Without DNA

Description:

Saliva used for cortisol and oxytocin extraction

Sampling Method

Non-Probability Sample

Study Population

Participants in the study group will be recrutied from psychiatric clinics, after a diagnosis of ASD has been made, and from special education kindergartens.

participants in the comparison group will be recruited by adds suggesting participiation in the study that were published in variose cities and on the internet.

Condition ^ICMJE

Autism Spectrum Disorders

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Autism Spectrum Disorders
Children with Autism Disorders and their parents
Typically Developing
Typically Developing children and their parents

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

For the study group:Children diagnosed with ASD
For the comparison group:Children with typical development

Exclusion Criteria:

For the study group:Non verbal children.
For the comparison group: Any major developmental disability.

Gender

Both

Ages

3 Years to 6 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT01643720

Other Study ID Numbers ^ICMJE

MMC1013010kCTIL

Has Data Monitoring Committee

Responsible Party

Meir Medical Center

Study Sponsor ^ICMJE

Meir Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:	Nathaniel Laor, MD	Brill Mental Health Center, Ramat Chen, Israel
Study Director:	Ofer Golan, PhD	Department of Psychology, Bar-Ilan University, Ramat-Gan, Israel
Study Director:	Ruth Feldman, PhD	Department of Psychology, Bar-Ilan University, Ramat-Gan, Israel
Principal Investigator:	Nathaniel Laor, MD	Brill Mental Health Center, Ramat Chen, Israel

Information Provided By

Meir Medical Center

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top