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Completed

NCT Number: 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:

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.

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Key information

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Brill Mental Health Center

Tel Aviv, 67197, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Meir Medical Center

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 18, 2012
Registry last updated
Apr 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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