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

NCT ID: NCT02898298

Last Updated: 2021-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2020-12-31

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.

Conditions

Neurodevelopmental Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Immediate

Immediate group receives the Positive Emotion Regulation training immediately.

Group Type: EXPERIMENTAL

Positive Emotion Regulation Training

Intervention Type: BEHAVIORAL

Participants will receive a 3-session psycho-educative training on emotion regulation.

Waitlist control group

Waitlist control group receives the Positive Emotion Regulation training 4 weeks later.

Group Type: ACTIVE_COMPARATOR

Positive Emotion Regulation Training

Intervention Type: BEHAVIORAL

Participants will receive a 3-session psycho-educative training on emotion regulation.

Interventions

Positive Emotion Regulation Training

Participants will receive a 3-session psycho-educative training on emotion regulation.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Geneva, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Andrea Samson

Senior Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Samson, Dr

Role: PRINCIPAL_INVESTIGATOR

University of Geneva

David Sander, Prof

Role: STUDY_CHAIR

University of Geneva

Locations

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

Geneva, , Switzerland

Countries

Switzerland

References

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Reference Type: BACKGROUND

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Other Identifiers

15-242

Identifier Type: -

Identifier Source: org_study_id