Emotion Regulation in Preschoolers With Autism and Their Parents

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Meir Medical Center.
Recruitment status was  Active, not recruiting
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
  Purpose

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
Autism Spectrum Disorders

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Emotion Regulation in Preschoolers With Autism and Their Parents

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples Without DNA

Saliva used for cortisol and oxytocin extraction


Estimated Enrollment: 80
Study Start Date: November 2010
Groups/Cohorts
Autism Spectrum Disorders
Children with Autism Disorders and their parents
Typically Developing
Typically Developing children and their parents

  Eligibility

Ages Eligible for Study:   3 Years to 6 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01643720     History of Changes
Other Study ID Numbers: MMC1013010kCTIL
Study First Received: July 4, 2012
Last Updated: August 9, 2012
Health Authority: Israel: Ethics Commission

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on October 30, 2014