Positive Emotion Regulation Training in Children, Adolescents and Young Adults With and Without Developmental Disorder (ERICA)

May 6, 2021 updated by: Andrea Samson, University of Geneva, Switzerland
The purpose of this study is to evaluate the efficacy of a novel positive emotion regulation intervention that aims to increase positive emotions and improve emotion regulation skills in children, adolescents and young adults. The study focuses on individuals with a developmental disorder such as Autism Spectrum Disorder and other Learning or Developmental Disabilities in comparison to typically developing (TD) controls. Participants will complete a psycho-educative training to learn about positive emotions and how to increase them in their daily lives. Participants are expected to benefit from the training, which will be evident in a change in emotion experience, emotion regulation strategy use, and well-being. Emotion regulation efficacy will be related to symptom severity (autistic symptoms), alexithymia and problematic behaviors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study aims at testing the efficacy of a 3-session psycho-educative training on emotion regulation and wellbeing in children and adolescents with or without developmental disorders with a waitlist control group design. Specifically, we are interested to improve different aspects of emotions, such as emotion experience, regulation strategy use, and beliefs on the malleability of emotions. Given that most of the past and actual interventions focus on negative emotions, our training will allow participants to learn more about positive emotions, how they can increase them, and how they can benefit from them.

Individuals with a developmental disorder including Autism Spectrum Disorder (ASD) will be recruited via flyers in specialized institutions and schools. Individuals with typical development (TD) will be recruited via flyers in schools, universities, libraries, and in other public places. Participants will be randomly assigned to the training or waiting list group (control). Randomization will be stratified for the two populations (i.e. with and without a developmental disorder) and for age. Participants and one of their parents (if <18 years) will be asked to fill in questionnaires on emotion experience, emotion regulation, beliefs about the malleability of emotions, well-being, problematic behaviors, alexithymia, and ASD symptom severity at four time points. Some questionnaires will only be completed by parents. Participants will be asked to answer additional questions on their emotional experience and emotion regulation and to provide examples of their own emotional experience and emotion regulation during and after each of the training sessions.

Participants are expected to benefit from the intervention, which should become evident in the changes of the primary outcome measures (emotion experience, emotion regulation, beliefs about the malleability of emotions, well-being) and the secondary outcome measures (problematic behaviors, alexithymia, and ASD symptom severity) post-intervention and at 8-weeks follow up.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1202
        • Swiss Center for Affective Sciences (Campus Biotech, University of Geneva)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 33 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants between 10-35 years old, presenting or not a developmental disorder (e.g., autism).

Exclusion Criteria:

  • Participants who are not able to understand the training instructions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate
Immediate group receives the Positive Emotion Regulation training immediately.
Behavioral: Positive Emotion Regulation Training
Participants will receive a 3-session psycho-educative training on emotion regulation.
Active Comparator: Waitlist control group
Waitlist control group receives the Positive Emotion Regulation training 4 weeks later.
Behavioral: Positive Emotion Regulation Training
Participants will receive a 3-session psycho-educative training on emotion regulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Positive and Negative Affect Scale
Time Frame: Week 1, Week 5, Week 9, Week 13 or 17
Change in emotion experience. Week 13 for immediate group, Week 17 for waitlist group.
Week 1, Week 5, Week 9, Week 13 or 17
Change in Emotion Regulation Questionnaire
Time Frame: Week 1, Week 5, Week 9, Week 13 or 17
Change in emotion regulation strategy use. Week 13 for immediate group, Week 17 for waitlist group.
Week 1, Week 5, Week 9, Week 13 or 17
Change in Satisfaction with Life Scale
Time Frame: Week 1, Week 5, Week 9, Week 13 or 17
Change in well-being. Week 13 for immediate group, Week 17 for waitlist group.
Week 1, Week 5, Week 9, Week 13 or 17
Change in Subjective Happiness Scale
Time Frame: Week 1, Week 5, Week 9, Week 13 or 17
Change in well-being. Week 13 for immediate group, Week 17 for waitlist group.
Week 1, Week 5, Week 9, Week 13 or 17

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Toronto Alexithymia Scale
Time Frame: Week 1, Week 5, Week 9, Week 13 or 17
Change in alexithymia scores. Week 13 for immediate group, Week 17 for waitlist group.
Week 1, Week 5, Week 9, Week 13 or 17
Change in Strength and Difficulties Questionnaire
Time Frame: Week 1, Week 5, Week 9, Week 13 or 17
Change in problematic behavior. Week 13 for immediate group, Week 17 for waitlist group.
Week 1, Week 5, Week 9, Week 13 or 17
Change in Autism Spectrum Quotient
Time Frame: Week 1, Week 5, Week 9, Week 13 or 17
Change in autism symptom severity. Week 13 for immediate group, Week 17 for waitlist group.
Week 1, Week 5, Week 9, Week 13 or 17

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants' experience and satisfaction with training (satisfaction questionnaire)
Time Frame: Week 13 or 17
Week 13 for immediate group, Week 17 for waitlist group.
Week 13 or 17

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Geneva, Switzerland

Investigators

  • Principal Investigator: Andrea Samson, Dr, University of Genova
  • Study Chair: David Sander, Prof, University of Genova

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

August 30, 2016

First Submitted That Met QC Criteria

September 7, 2016

First Posted (Estimate)

September 13, 2016

Study Record Updates

Last Update Posted (Actual)

May 11, 2021

Last Update Submitted That Met QC Criteria

May 6, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-242

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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