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

Primary Purpose

Neurodevelopmental Disorders

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Positive Emotion Regulation Training
Sponsored by
University of Geneva, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurodevelopmental Disorders

Eligibility Criteria

10 Years - 35 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immediate

Waitlist control group

Arm Description

Immediate group receives the Positive Emotion Regulation training immediately.

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

Outcomes

Primary Outcome Measures

Change in Positive and Negative Affect Scale
Change in emotion experience. Week 13 for immediate group, Week 17 for waitlist group.
Change in Emotion Regulation Questionnaire
Change in emotion regulation strategy use. Week 13 for immediate group, Week 17 for waitlist group.
Change in Satisfaction with Life Scale
Change in well-being. Week 13 for immediate group, Week 17 for waitlist group.
Change in Subjective Happiness Scale
Change in well-being. Week 13 for immediate group, Week 17 for waitlist group.

Secondary Outcome Measures

Change in Toronto Alexithymia Scale
Change in alexithymia scores. Week 13 for immediate group, Week 17 for waitlist group.
Change in Strength and Difficulties Questionnaire
Change in problematic behavior. Week 13 for immediate group, Week 17 for waitlist group.
Change in Autism Spectrum Quotient
Change in autism symptom severity. Week 13 for immediate group, Week 17 for waitlist group.

Full Information

First Posted
August 30, 2016
Last Updated
May 6, 2021
Sponsor
University of Geneva, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT02898298
Brief Title
Positive Emotion Regulation Training in Children, Adolescents and Young Adults With and Without Developmental Disorder
Acronym
ERICA
Official Title
Positive Emotion Regulation Training in Children, Adolescents and Young Adults With and Without Developmental Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Geneva, Switzerland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurodevelopmental Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate
Arm Type
Experimental
Arm Description
Immediate group receives the Positive Emotion Regulation training immediately.
Arm Title
Waitlist control group
Arm Type
Active Comparator
Arm Description
Waitlist control group receives the Positive Emotion Regulation training 4 weeks later.
Intervention Type
Behavioral
Intervention Name(s)
Positive Emotion Regulation Training
Intervention Description
Participants will receive a 3-session psycho-educative training on emotion regulation.
Primary Outcome Measure Information:
Title
Change in Positive and Negative Affect Scale
Description
Change in emotion experience. Week 13 for immediate group, Week 17 for waitlist group.
Time Frame
Week 1, Week 5, Week 9, Week 13 or 17
Title
Change in Emotion Regulation Questionnaire
Description
Change in emotion regulation strategy use. Week 13 for immediate group, Week 17 for waitlist group.
Time Frame
Week 1, Week 5, Week 9, Week 13 or 17
Title
Change in Satisfaction with Life Scale
Description
Change in well-being. Week 13 for immediate group, Week 17 for waitlist group.
Time Frame
Week 1, Week 5, Week 9, Week 13 or 17
Title
Change in Subjective Happiness Scale
Description
Change in well-being. Week 13 for immediate group, Week 17 for waitlist group.
Time Frame
Week 1, Week 5, Week 9, Week 13 or 17
Secondary Outcome Measure Information:
Title
Change in Toronto Alexithymia Scale
Description
Change in alexithymia scores. Week 13 for immediate group, Week 17 for waitlist group.
Time Frame
Week 1, Week 5, Week 9, Week 13 or 17
Title
Change in Strength and Difficulties Questionnaire
Description
Change in problematic behavior. Week 13 for immediate group, Week 17 for waitlist group.
Time Frame
Week 1, Week 5, Week 9, Week 13 or 17
Title
Change in Autism Spectrum Quotient
Description
Change in autism symptom severity. Week 13 for immediate group, Week 17 for waitlist group.
Time Frame
Week 1, Week 5, Week 9, Week 13 or 17
Other Pre-specified Outcome Measures:
Title
Participants' experience and satisfaction with training (satisfaction questionnaire)
Description
Week 13 for immediate group, Week 17 for waitlist group.
Time Frame
Week 13 or 17

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Samson, Dr
Organizational Affiliation
University of Geneva
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Sander, Prof
Organizational Affiliation
University of Geneva
Official's Role
Study Chair
Facility Information:
Facility Name
Swiss Center for Affective Sciences (Campus Biotech, University of Geneva)
City
Geneva
ZIP/Postal Code
1202
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
9457784
Citation
Gross JJ. Antecedent- and response-focused emotion regulation: divergent consequences for experience, expression, and physiology. J Pers Soc Psychol. 1998 Jan;74(1):224-37. doi: 10.1037//0022-3514.74.1.224.
Results Reference
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Citation
Gross JJ (2014). Emotion regulation: Conceptual and empirical foundations. In J.J. Gross (Ed.), Handbook of emotion regulation (2nd ed.) (pp. 3-20). New York, NY: Guilford.
Results Reference
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Citation
Gross, JJ, Jazaieri, H. Emotion, emotion regulation, and psychopathology an affective science perspective. Clinical Psychological Science 2(4): 387-401, 2014.
Results Reference
background
PubMed Identifier
22639681
Citation
Mazefsky CA, Pelphrey KA, Dahl RE. The Need for a Broader Approach to Emotion Regulation Research in Autism. Child Dev Perspect. 2012 Mar 1;6(1):92-97. doi: 10.1111/j.1750-8606.2011.00229.x. Epub 2012 Jan 12.
Results Reference
background
PubMed Identifier
23800481
Citation
Mazefsky CA, Herrington J, Siegel M, Scarpa A, Maddox BB, Scahill L, White SW. The role of emotion regulation in autism spectrum disorder. J Am Acad Child Adolesc Psychiatry. 2013 Jul;52(7):679-88. doi: 10.1016/j.jaac.2013.05.006. Epub 2013 Jun 3.
Results Reference
background
PubMed Identifier
25621978
Citation
Quoidbach J, Mikolajczak M, Gross JJ. Positive interventions: An emotion regulation perspective. Psychol Bull. 2015 May;141(3):655-93. doi: 10.1037/a0038648. Epub 2015 Jan 26.
Results Reference
background
Citation
Riediger M, Klipker, K. (2014). Emotion regulation in adolescence. In Handbook of emotion regulation (pp. 187-202). Guilford Press.
Results Reference
background
PubMed Identifier
22642342
Citation
Samson AC, Huber O, Gross JJ. Emotion regulation in Asperger's syndrome and high-functioning autism. Emotion. 2012 Aug;12(4):659-65. doi: 10.1037/a0027975. Epub 2012 May 28.
Results Reference
background
Citation
Samson AC, Huber O, Ruch W. Seven decades after Hans Asperger's observations: A comprehensive study of humor in individuals with Autism Spectrum Disorders. Humor, 26(3): 441-460, 2013.
Results Reference
background
PubMed Identifier
25711546
Citation
Samson AC, Hardan AY, Lee IA, Phillips JM, Gross JJ. Maladaptive Behavior in Autism Spectrum Disorder: The Role of Emotion Experience and Emotion Regulation. J Autism Dev Disord. 2015 Nov;45(11):3424-32. doi: 10.1007/s10803-015-2388-7.
Results Reference
background
PubMed Identifier
24863869
Citation
Samson AC, Hardan AY, Podell RW, Phillips JM, Gross JJ. Emotion regulation in children and adolescents with autism spectrum disorder. Autism Res. 2015 Feb;8(1):9-18. doi: 10.1002/aur.1387. Epub 2014 May 23.
Results Reference
background
PubMed Identifier
24362795
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.
Results Reference
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PubMed Identifier
24759870
Citation
Weytens F, Luminet O, Verhofstadt LL, Mikolajczak M. An integrative theory-driven positive emotion regulation intervention. PLoS One. 2014 Apr 23;9(4):e95677. doi: 10.1371/journal.pone.0095677. eCollection 2014.
Results Reference
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PubMed Identifier
34790142
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.
Results Reference
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Positive Emotion Regulation Training in Children, Adolescents and Young Adults With and Without Developmental Disorder

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