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Completed

NCT Number: NCT02898298

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

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.

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Key information

Age range

10 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Geneva, 1202, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Positive Emotion Regulation Training

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. Participants' experience and satisfaction with training (satisfaction questionnaire)

    Time frame: Week 13 or 17

    Week 13 for immediate group, Week 17 for waitlist group.

Sponsors and collaborators

Lead sponsor

University of Geneva, Switzerland

Other

Registry information

Acronym: ERICA

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Sep 13, 2016
Registry last updated
May 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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