Emotion Regulation in Preschoolers With Autism and Their Parents

Autism Spectrum Disorders Clinical Trial

Official title:

Emotion Regulation in Preschoolers With Autism and Their Parents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01643720
• Other study ID #: MMC1013010kCTIL
• Status: Completed
• Phase: N/A
• First received: July 4, 2012
• Last updated: April 7, 2015
• Start date: November 2010
• Est. completion date: May 2011

Study information

• Verified date: September 2013
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 6 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Autism Spectrum Disorders
• Autistic Disorder
• Child Development Disorders, Pervasive

Locations

Country	Name	City	State
Israel	Brill Mental Health Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emotion regulation(ER)strategies during emotion eliciting episodes	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	No
Secondary	Salivary hormone levels: Cortisol and Oxytocin of both parent and child	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.	No