NCT02898298

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

August 30, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

May 11, 2021

Status Verified

May 1, 2021

Enrollment Period

4.4 years

First QC Date

August 30, 2016

Last Update Submit

May 6, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (3)

  • Change in Toronto Alexithymia Scale

    Week 1, Week 5, Week 9, Week 13 or 17

  • Change in Strength and Difficulties Questionnaire

    Week 1, Week 5, Week 9, Week 13 or 17

  • Change in Autism Spectrum Quotient

    Week 1, Week 5, Week 9, Week 13 or 17

Other Outcomes (1)

  • Participants' experience and satisfaction with training (satisfaction questionnaire)

    Week 13 or 17

Study Arms (2)

Immediate

EXPERIMENTAL

Immediate group receives the Positive Emotion Regulation training immediately.

Behavioral: Positive Emotion Regulation Training

Waitlist control group

ACTIVE COMPARATOR

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

Behavioral: Positive Emotion Regulation Training

Interventions

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

ImmediateWaitlist control group

Eligibility Criteria

Age10 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Participants between 10-35 years old, presenting or not a developmental disorder (e.g., autism).

You may not qualify if:

  • Participants who are not able to understand the training instructions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Geneva, 1202, Switzerland

Location

Related Publications (14)

  • 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.

    PMID: 9457784BACKGROUND
  • 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.

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

    BACKGROUND
  • 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.

    PMID: 22639681BACKGROUND
  • 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.

    PMID: 23800481BACKGROUND
  • 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.

    PMID: 25621978BACKGROUND
  • Riediger M, Klipker, K. (2014). Emotion regulation in adolescence. In Handbook of emotion regulation (pp. 187-202). Guilford Press.

    BACKGROUND
  • 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.

    PMID: 22642342BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 25711546BACKGROUND
  • 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.

    PMID: 24863869BACKGROUND
  • 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.

    PMID: 24362795BACKGROUND
  • 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.

    PMID: 24759870BACKGROUND
  • 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.

MeSH Terms

Conditions

Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Andrea Samson, Dr

    University of Geneva

    PRINCIPAL INVESTIGATOR
  • David Sander, Prof

    University of Geneva

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researcher

Study Record Dates

First Submitted

August 30, 2016

First Posted

September 13, 2016

Study Start

August 1, 2016

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

May 11, 2021

Record last verified: 2021-05

Locations