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Clinical Trials/NCT02898298
NCT02898298
Completed
Not Applicable

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

University of Geneva, Switzerland1 site in 1 country60 target enrollmentAugust 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neurodevelopmental Disorders
Sponsor
University of Geneva, Switzerland
Enrollment
60
Locations
1
Primary Endpoint
Change in Emotion Regulation Questionnaire
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
August 2016
End Date
December 31, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Geneva, Switzerland
Responsible Party
Principal Investigator
Principal Investigator

Andrea Samson

Senior Researcher

University of Geneva, Switzerland

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

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.

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.

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.

Secondary Outcomes

  • Change in Toronto Alexithymia Scale(Week 1, Week 5, Week 9, Week 13 or 17)
  • Change in Autism Spectrum Quotient(Week 1, Week 5, Week 9, Week 13 or 17)
  • Change in Strength and Difficulties Questionnaire(Week 1, Week 5, Week 9, Week 13 or 17)

Study Sites (1)

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