Emotion Regulation in Preschoolers With Autism and Their Parents

April 7, 2015 updated by: Meir Medical Center

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:

  1. ER strategies used by children with ASD will be more poorly developed and less effective, compared to those of children in the control groups.
  2. Difficult temperament and sensory regulation difficulties will hamper ER in children with ASD.
  3. ER strategies of parents of children with ASD will be more poorly developed and less effective than those of parents in the control groups.
  4. 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.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Tel Aviv, Israel, 67197
        • Brill Mental Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Autism Spectrum Disorders
Children with Autism Disorders and their parents
Typically Developing
Typically Developing children and their parents

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emotion regulation(ER)strategies during emotion eliciting episodes
Time Frame: During a 2hr home visit, while the child interacts with the parent
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
During a 2hr home visit, while the child interacts with the parent

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
collected 4 times during the assessment meeting, from both child and parent.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

July 4, 2012

First Submitted That Met QC Criteria

July 16, 2012

First Posted (Estimate)

July 18, 2012

Study Record Updates

Last Update Posted (Estimate)

April 8, 2015

Last Update Submitted That Met QC Criteria

April 7, 2015

Last Verified

September 1, 2013

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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