Autism Spectrum DisordersNCT01643720
Emotion Regulation in Preschoolers With Autism and Their Parents
An observational study of Autism Spectrum Disorders, run by Meir Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorders
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2010to May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- For the study group:Children diagnosed with ASD
- For the comparison group:Children with typical development
Who cannot join
- For the study group:Non verbal children.
- For the comparison group: Any major developmental disability.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Autism Spectrum Disorders
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Autism Spectrum Disorders | Children with Autism Disorders and their parents | |
| Typically Developing | Typically Developing children and their parents |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During a 2hr home visit, while the child interacts with the parent
Secondary outcomes (1)
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.
Measured: collected 4 times during the assessment meeting, from both child and parent.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2012 (estimated)
- Study startNov 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathaniel Laor, MD, Study chair, Brill Mental Health Center, Ramat Chen, IsraelOfer Golan, PhD, Study director, Department of Psychology, Bar-Ilan University, Ramat-Gan, IsraelRuth Feldman, PhD, Study director, Department of Psychology, Bar-Ilan University, Ramat-Gan, IsraelNathaniel Laor, MD, Principal investigator, Brill Mental Health Center, Ramat Chen, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01643720
- Sponsor's protocol ID
- MMC1013010kCTIL
- Status last verified
- Sep 2013
- First submitted
- 4 Jul 2012
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotion Regulation in Preschoolers With Autism and Their Parents
- ClinicalTrials.gov ID
- NCT01643720
- Acronym / sponsor ID
- MMC1013010kCTIL
- Conditions
- Autism Spectrum Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 18 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autism Spectrum Disorders | – | –Children with Autism Disorders and their parents |
| Typically Developing | – | –Typically Developing children and their parents |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- For the study group:Children diagnosed with ASD
- For the comparison group:Children with typical development
Key exclusion criteria (2 listed)
- For the study group:Non verbal children.
- For the comparison group: Any major developmental disability.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathaniel Laor, MD study chair
Brill Mental Health Center, Ramat Chen, Israel
Ofer Golan, PhD study director
Department of Psychology, Bar-Ilan University, Ramat-Gan, Israel
Ruth Feldman, PhD study director
Department of Psychology, Bar-Ilan University, Ramat-Gan, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorders, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotion regulation(ER)strategies during emotion eliciting episodes (time frame: During a 2hr home visit, while the child interacts with the parent). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2015.