Clinical trial NCT02898298: Positive Emotion Regulation Training in Children, Adolescents and Young Adults With and Without Developmental Disorder
Official title: Positive Emotion Regulation Training in Children, Adolescents and Young Adults With and Without Developmental Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurodevelopmental Disorders
Lead sponsor: University of Geneva, Switzerland
Sponsor class: OTHER
First posted: 2016-09-13
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Positive and Negative Affect Scale
timeFrame: Week 1, Week 5, Week 9, Week 13 or 17
measure: Change in Emotion Regulation Questionnaire
timeFrame: Week 1, Week 5, Week 9, Week 13 or 17
measure: Change in Satisfaction with Life Scale
timeFrame: Week 1, Week 5, Week 9, Week 13 or 17
measure: Change in Subjective Happiness Scale
timeFrame: Week 1, Week 5, Week 9, Week 13 or 17
Secondary outcomes:
measure: Change in Toronto Alexithymia Scale
timeFrame: Week 1, Week 5, Week 9, Week 13 or 17
measure: Change in Strength and Difficulties Questionnaire
timeFrame: Week 1, Week 5, Week 9, Week 13 or 17
measure: Change in Autism Spectrum Quotient
timeFrame: Week 1, Week 5, Week 9, Week 13 or 17
Other outcomes:
measure: Participants' experience and satisfaction with training (satisfaction questionnaire)
timeFrame: Week 13 or 17
Locations:
city: Geneva
country: Switzerland
facility: Swiss Center for Affective Sciences (Campus Biotech, University of Geneva)
Study officials:
affiliation: University of Geneva
name: Andrea Samson, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Geneva
name: David Sander, Prof
role: STUDY_CHAIR
References:
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citation: Samson AC, Phillips JM, Parker KJ, Shah S, Gross JJ, Hardan AY. Emotion dysregulation and the core features of autism spectrum disorder. J Autism Dev Disord. 2014 Jul;44(7):1766-72. doi: 10.1007/s10803-013-2022-5.
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citation: Zaharia A, Noir-Kahlo K, Bressoud N, Sander D, Dukes D, Samson AC. Proof of Concept: A Brief Psycho-Educational Training Program to Increase the Use of Positive Emotion Regulation Strategies in Individuals With Autism Spectrum Disorder. Front Psychol. 2021 Nov 1;12:705937. doi: 10.3389/fpsyg.2021.705937. eCollection 2021.