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Emotion Regulation in Preschoolers With Autism and Their Parents

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ClinicalTrials.gov Identifier: NCT01643720
Recruitment Status : Completed
First Posted : July 18, 2012
Last Update Posted : April 8, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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:

  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.

Condition or disease
Autism Spectrum Disorders

Study Design

Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Emotion Regulation in Preschoolers With Autism and Their Parents
Study Start Date : November 2010
Primary Completion Date : May 2011
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples Without DNA
Saliva used for cortisol and oxytocin extraction

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
Contacts and Locations

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): NCT01643720


Locations
Israel
Brill Mental Health Center
Tel Aviv, Israel, 67197
Sponsors and Collaborators
Meir Medical Center
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
More Information

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01643720     History of Changes
Other Study ID Numbers: MMC1013010kCTIL
First Posted: July 18, 2012    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: September 2013

Additional relevant MeSH terms:
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders