Autism Spectrum DisordersNCT02400177
Parents Workgroup About Emotion Regulation
A study testing emotion regulation training in people with Autism Spectrum Disorders, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is examine emotional regulation and reflective functioning in parents of children with Autism Spectrum Disorders (ASD) before and after an educational training (four sessions of group workshops). Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorders
- What is being tested?
- emotion regulation training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Nov 2016
- Phase
- Interventional
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Parents of children with autism ages 3-18
Who cannot join
- If they cant understand English they can not be part of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Parenting Workshop on Emotion Regulation
The purpose of this study is examine emotional regulation and reflective functioning in parents of children with Autism Spectrum Disorders (ASD) before and after an educational training (four sessions of group workshops). Our experimental aims are the following: 1) examine parental emotion regulation and reflective functioning in daily life, 2) examine child emotion regulation in their daily life 3)Learn about the training efficacy for ASD parents. This research study will help to formulate innovative treatment methods to reinforce positive emotion regulation and reflective functioning in both ASD children and their parents.
Read the detailed description
The parents will answer questionnaires and Parent Development Interview (PDI) and the Five Minute Free Speech Sample (FMSS) as well as a number of other questionnaires.
Parents will be randomized between intervention group and control group. First session
- Introduction
- Setting expectations and goals
- General explanation of emotions and their development.
- How to recognize emotions? Why is it important to recognize them?
- Minding parents and child emotions. Second session
- Emotion Regulation (general explanation).
- Strategic for emotion regulation (Adults)
- Strategic for emotion regulation (children)
- Parental emotion regulation and the influence on the child emotion regulation
- Difficulties in ER among children with ASD Third session
- Three steps method: Feel, Think-Rethink, Regulate.
- Theory, explanation and implementation.
- Discussion: Role play of challenging highly affective parent-child interaction
Fourth session:
- Three steps method: Feel, Think-Rethink, Regulate.
- Theory, explanation and implementation.
- Discussion: Role play of challenging highly affective parent-child interaction The parents will do another PDI and will fill up the questionnaires
- Conditions
- Autism Spectrum Disorders
- Being tested
- emotion regulation training
- 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.
emotion regulation trainingBehavioural
Also called Regulative Parenting
This is a workshop for parents that help them to understand how to deal with emotions generally and specifically with their ASD children's emotion
| Study group | Role | What they receive |
|---|---|---|
| Emotion regulation training | Experimental | This is a 4 sessions group workshop and 1 session individual pre-screening about parental emotion regulation and emotion co-regulation. In this study the facilitators will give information about efficient strategies to regulate parent emotions and their children's emotions. Receives: Behavioral: emotion regulation training |
| Control group | No intervention | In this condition we will take all the measurement before and after the waiting list period. This group will go through the workshop after the measurements will be taken. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mentalization level
By the Parent Development Interview (PDI) before and after the workshop we measure the metallization level
Measured: 1 month - 2 months
Secondary outcomes (1)
Relationship coherence level
By the FMSS (5 min speech sample)
Measured: 1 month - 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionNov 2016
- Study completionNov 2016
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.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Hardan, Stanford University
- Investigators
- Antonio Hardan, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400177
- Sponsor's protocol ID
- IRB32455
- Status last verified
- May 2018
- First submitted
- 23 Mar 2015
- Last updated
- 1 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parenting Workshop on Emotion Regulation
- ClinicalTrials.gov ID
- NCT02400177
- Acronym / sponsor ID
- IRB32455
- Conditions
- Autism Spectrum Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 26 Mar 2015 (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.
The purpose of this study is examine emotional regulation and reflective functioning in parents of children with Autism Spectrum Disorders (ASD) before and after an educational training (four sessions of group workshops). Our experimental aims are the following: 1) examine parental emotion regulation and reflective functioning in daily life, 2) examine child emotion regulation in their daily life 3)Learn about the training efficacy for ASD parents. This research study will help to formulate innovative treatment methods to reinforce positive emotion regulation and reflective functioning in both ASD children and their parents.
Detailed description
The parents will answer questionnaires and Parent Development Interview (PDI) and the Five Minute Free Speech Sample (FMSS) as well as a number of other questionnaires.
Parents will be randomized between intervention group and control group. First session
- Introduction
- Setting expectations and goals
- General explanation of emotions and their development.
- How to recognize emotions? Why is it important to recognize them?
- Minding parents and child emotions. Second session
- Emotion Regulation (general explanation).
- Strategic for emotion regulation (Adults)
- Strategic for emotion regulation (children)
- Parental emotion regulation and the influence on the child emotion regulation
- Difficulties in ER among children with ASD Third session
- Three steps method: Feel, Think-Rethink, Regulate.
- Theory, explanation and implementation.
- Discussion: Role play of challenging highly affective parent-child interaction
Fourth session:
- Three steps method: Feel, Think-Rethink, Regulate.
- Theory, explanation and implementation.
- Discussion: Role play of challenging highly affective parent-child interaction The parents will do another PDI and will fill up the questionnaires
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emotion regulation training | Experimental | Behavioral: emotion regulation trainingThis is a 4 sessions group workshop and 1 session individual pre-screening about parental emotion regulation and emotion co-regulation. In this study the facilitators will give information about efficient strategies to regulate parent emotions and their children's emotions. |
| Control group | No intervention | –In this condition we will take all the measurement before and after the waiting list period. This group will go through the workshop after the measurements will be taken. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Parents of children with autism ages 3-18
Key exclusion criteria (1 listed)
- If they cant understand English they can not be part of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| emotion regulation trainingAlso: Regulative ParentingThis is a workshop for parents that help them to understand how to deal with emotions generally and specifically with their ASD children's emotion | Behavioural | Emotion regulation training |
Primary outcome
Mentalization level
Time frame: 1 month - 2 months
By the Parent Development Interview (PDI) before and after the workshop we measure the metallization level
1 secondary outcome
Relationship coherence level
Time frame: 1 month - 2 months
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 1 Jun 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Autism Spectrum Disorders
Recruiting
Word Learning From Parentese in Autistic Children
Autism, Autism Spectrum Disorder
Recruiting
COMPASS Across Settings (CAST) for Improving Transition Outcomes for Students With ASD
Autism, Autism Spectrum Disorder
Recruiting
Impact of an E-Learning Coaching for Parents of Young Children With Autism
Autism Spectrum Disorder
Not yet recruiting
Evaluation of a Novel Quantum-Inspired Intervention (QII) for Children With Autism Spectrum Disorder: A Global Confirmatory Study
Autism Spectrum Disorder, Autism Spectrum Disorder (ASD
Not yet recruiting
Single Session Support for Parents of Children With Neurodevelopmental Disabilities Struggling With Anxious Avoidance
Neurodevelopmental Disorders, Autism Spectrum Disorder (ASD)
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.
Antonio Hardan, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing emotion regulation training in people with Autism Spectrum Disorders, run by Stanford University at 1 site in United States.
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 1 inclusion and 1 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 1 Jun 2018. 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 United States. 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?
Mentalization level (time frame: 1 month - 2 months). 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 1 Jun 2018.