- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01643720
Emotion Regulation in Preschoolers With Autism and Their Parents
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Tel Aviv, Israel, 67197
- Brill Mental Health Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Autism Spectrum Disorders
Children with Autism Disorders and their parents
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Typically Developing
Typically Developing children and their parents
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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
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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
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During a 2hr home visit, while the child interacts with the parent
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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.
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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.
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collected 4 times during the assessment meeting, from both child and parent.
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Collaborators and Investigators
Sponsor
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
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MMC1013010kCTIL
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