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

Neurodevelopmental Disorders Clinical Trial

— ERICA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02898298
• Other study ID #: 15-242
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2021
• Source: University of Geneva, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Developmental Disabilities
• Neurodevelopmental Disorders

Intervention

Behavioral:
• Positive Emotion Regulation Training
Participants will receive a 3-session psycho-educative training on emotion regulation.

Locations

Country	Name	City	State
Switzerland	Swiss Center for Affective Sciences (Campus Biotech, University of Geneva)	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University of Geneva, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (13)

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.

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. — View Citation

Gross, JJ, Jazaieri, H. Emotion, emotion regulation, and psychopathology an affective science perspective. Clinical Psychological Science 2(4): 387-401, 2014.

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. Review. — View 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. Epub 2012 Jan 12. — View 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. Review. — View Citation

Riediger M, Klipker, K. (2014). Emotion regulation in adolescence. In Handbook of emotion regulation (pp. 187-202). Guilford Press.

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. — View 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. — View 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. — View 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.

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. — View 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Participants' experience and satisfaction with training (satisfaction questionnaire)	Week 13 for immediate group, Week 17 for waitlist group.	Week 13 or 17
Primary	Change in Positive and Negative Affect Scale	Change in emotion experience. Week 13 for immediate group, Week 17 for waitlist group.	Week 1, Week 5, Week 9, Week 13 or 17
Primary	Change in Emotion Regulation Questionnaire	Change in emotion regulation strategy use. Week 13 for immediate group, Week 17 for waitlist group.	Week 1, Week 5, Week 9, Week 13 or 17
Primary	Change in Satisfaction with Life Scale	Change in well-being. Week 13 for immediate group, Week 17 for waitlist group.	Week 1, Week 5, Week 9, Week 13 or 17
Primary	Change in Subjective Happiness Scale	Change in well-being. Week 13 for immediate group, Week 17 for waitlist group.	Week 1, Week 5, Week 9, Week 13 or 17
Secondary	Change in Toronto Alexithymia Scale	Change in alexithymia scores. Week 13 for immediate group, Week 17 for waitlist group.	Week 1, Week 5, Week 9, Week 13 or 17
Secondary	Change in Strength and Difficulties Questionnaire	Change in problematic behavior. Week 13 for immediate group, Week 17 for waitlist group.	Week 1, Week 5, Week 9, Week 13 or 17
Secondary	Change in Autism Spectrum Quotient	Change in autism symptom severity. Week 13 for immediate group, Week 17 for waitlist group.	Week 1, Week 5, Week 9, Week 13 or 17