Clinical trial NCT01643720: Emotion Regulation in Preschoolers With Autism and Their Parents
Official title: Emotion Regulation in Preschoolers With Autism and Their Parents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism Spectrum Disorders
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2012-07-18
Enrollment: 80
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Emotion regulation(ER)strategies during emotion eliciting episodes
timeFrame: During a 2hr home visit, while the child interacts with the parent
Secondary outcomes:
measure: Salivary hormone levels: Cortisol and Oxytocin of both parent and child
timeFrame: collected 4 times during the assessment meeting, from both child and parent.
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Brill Mental Health Center
Study officials:
affiliation: Brill Mental Health Center, Ramat Chen, Israel
name: Nathaniel Laor, MD
role: STUDY_CHAIR
affiliation: Department of Psychology, Bar-Ilan University, Ramat-Gan, Israel
name: Ofer Golan, PhD
role: STUDY_DIRECTOR
affiliation: Department of Psychology, Bar-Ilan University, Ramat-Gan, Israel
name: Ruth Feldman, PhD
role: STUDY_DIRECTOR
affiliation: Brill Mental Health Center, Ramat Chen, Israel
name: Nathaniel Laor, MD
role: PRINCIPAL_INVESTIGATOR
References: