NCT02400177

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

June 1, 2018

Status Verified

May 1, 2018

Enrollment Period

1.7 years

First QC Date

March 23, 2015

Last Update Submit

May 30, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mentalization level

    By the Parent Development Interview (PDI) before and after the workshop we measure the metallization level

    1 month - 2 months

Secondary Outcomes (1)

  • Relationship coherence level

    1 month - 2 months

Study Arms (2)

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.

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.

Interventions

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

Also known as: Regulative Parenting
Emotion regulation training

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Parents of children with autism ages 3-18

You may not qualify if:

  • If they cant understand English they can not be part of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94306, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Antonio Hardan, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

March 23, 2015

First Posted

March 26, 2015

Study Start

March 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

June 1, 2018

Record last verified: 2018-05

Locations