Expired Study
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Stanford, California 94306


Purpose:

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.


Study summary:

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


Criteria:

Inclusion Criteria: - Parents of children with autism ages 3-18 Exclusion Criteria: - If they cant understand English they can not be part of the study.


Study is Available At:


Original ID:

IRB32455


NCT ID:

NCT02400177


Secondary ID:


Study Acronym:


Brief Title:

Parents Workgroup About Emotion Regulation


Official Title:

Parenting Workshop on Emotion Regulation


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

3 Years


Maximum Age:

18 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Stanford University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

96


Enrollment Type:

Actual


Overall Contact Information

Official Name:Antonio Hardan, MD
Principal Investigator
Stanford University

Study Dates

Start Date:March 2015
Completion Date:November 2016
Completion Type:Actual
Primary Completion Date:November 2016
Primary Completion Type:Actual
Verification Date:May 2018
Last Changed Date:May 30, 2018
First Received Date:March 23, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Mentalization level
Time Frame:1 month - 2 months
Safety Issues:False
Description:By the Parent Development Interview (PDI) before and after the workshop we measure the metallization level
Outcome Type:Secondary Outcome
Measure:Relationship coherence level
Time Frame:1 month - 2 months
Safety Issues:False
Description:By the FMSS (5 min speech sample)

Study Interventions

Intervention Type:Behavioral
Name:emotion regulation training
Description: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
Arm Name:Emotion regulation training
Other Name:Regulative Parenting

Study Arms

Study Arm Type:Experimental
Arm Name:Emotion regulation training
Description: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.
Study Arm Type:No Intervention
Arm Name:Control group
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Stanford University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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