Neurodevelopmental DisordersERICANCT02898298
Positive Emotion Regulation Training in Children, Adolescents and Young Adults With and Without Developmental Disorder
A study testing Positive Emotion Regulation Training in people with Neurodevelopmental Disorders, run by University of Geneva, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 10 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurodevelopmental Disorders
- What is being tested?
- Positive Emotion Regulation Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2016to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Participants between 10-35 years old, presenting or not a developmental disorder (e.g., autism).
Who cannot join
- Participants who are not able to understand the training instructions.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Center for Affective Sciences (Campus Biotech, University of Geneva)
Geneva, 1202
About this study
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.
Read the 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.
- Conditions
- Neurodevelopmental Disorders
- Being tested
- Positive Emotion Regulation Training
- Medical subject headings
- Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Emotion Regulation TrainingBehavioural
Participants will receive a 3-session psycho-educative training on emotion regulation.
| Study group | Role | What they receive |
|---|---|---|
| Immediate | Experimental | Immediate group receives the Positive Emotion Regulation training immediately. Receives: Behavioral: Positive Emotion Regulation Training |
| Waitlist control group | Active comparator | Waitlist control group receives the Positive Emotion Regulation training 4 weeks later. Receives: Behavioral: Positive Emotion Regulation Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Positive and Negative Affect Scale
Change in emotion experience. Week 13 for immediate group, Week 17 for waitlist group.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 1, Week 5, Week 9, Week 13 or 17
Secondary outcomes (3)
Change in Toronto Alexithymia Scale
Change in alexithymia scores. Week 13 for immediate group, Week 17 for waitlist group.
Measured: Week 1, Week 5, Week 9, Week 13 or 17
Change in Strength and Difficulties Questionnaire
Change in problematic behavior. Week 13 for immediate group, Week 17 for waitlist group.
Measured: Week 1, Week 5, Week 9, Week 13 or 17
Change in Autism Spectrum Quotient
Change in autism symptom severity. Week 13 for immediate group, Week 17 for waitlist group.
Measured: Week 1, Week 5, Week 9, Week 13 or 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startAug 2016
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Neurodevelopmental DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Geneva, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Samson, University of Geneva, Switzerland
- Investigators
- Andrea Samson, Dr, Principal investigator, University of Geneva, SwitzerlandDavid Sander, Prof, Study chair, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02898298
- Sponsor's protocol ID
- 15-242
- Acronym
- ERICA
- Status last verified
- May 2021
- First submitted
- 30 Aug 2016
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 9457784Gross 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, Jazaieri, H. Emotion, emotion regulation, and psychopathology an affective science perspective. Clinical Psychological Science 2(4): 387-401, 2014.
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.
PubMed 22639681Mazefsky 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.
PubMed 23800481Quoidbach 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.
PubMed 25621978Riediger M, Klipker, K. (2014). Emotion regulation in adolescence. In Handbook of emotion regulation (pp. 187-202). Guilford Press.
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.
PubMed 22642342Samson 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, 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.
PubMed 25711546Samson 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.
PubMed 24863869Samson 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.
PubMed 24362795Weytens 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.
PubMed 24759870Zaharia 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.
PubMed 34790142
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Emotion Regulation Training in Children, Adolescents and Young Adults With and Without Developmental Disorder
- ClinicalTrials.gov ID
- NCT02898298
- Acronym / sponsor ID
- ERICA / 15-242
- Conditions
- Neurodevelopmental Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Geneva, SwitzerlandUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 13 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate | Experimental | Behavioral: Positive Emotion Regulation TrainingImmediate group receives the Positive Emotion Regulation training immediately. |
| Waitlist control group | Active comparator | Behavioral: Positive Emotion Regulation TrainingWaitlist control group receives the Positive Emotion Regulation training 4 weeks later. |
Who may qualify
- Ages
- 10 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Participants between 10-35 years old, presenting or not a developmental disorder (e.g., autism).
Key exclusion criteria (1 listed)
- Participants who are not able to understand the training instructions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive Emotion Regulation TrainingParticipants will receive a 3-session psycho-educative training on emotion regulation. | Behavioural | Immediate, Waitlist control group |
Primary outcome
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.
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.
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.
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.
3 secondary outcomes
Change in Toronto Alexithymia Scale
Time frame: Week 1, Week 5, Week 9, Week 13 or 17
Change in Strength and Difficulties Questionnaire
Time frame: Week 1, Week 5, Week 9, Week 13 or 17
Change in Autism Spectrum Quotient
Time frame: Week 1, Week 5, Week 9, Week 13 or 17
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Background: PubMed 9457784Gross 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.
- BackgroundGross 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.
- BackgroundGross, JJ, Jazaieri, H. Emotion, emotion regulation, and psychopathology an affective science perspective. Clinical Psychological Science 2(4): 387-401, 2014.
- Background: PubMed 22639681Mazefsky 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.
- Background: PubMed 23800481Mazefsky 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.
- Background: PubMed 25621978Quoidbach 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.
- BackgroundRiediger M, Klipker, K. (2014). Emotion regulation in adolescence. In Handbook of emotion regulation (pp. 187-202). Guilford Press.
- Background: PubMed 22642342Samson 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.
- BackgroundSamson 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: PubMed 25711546Samson 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.
- Background: PubMed 24863869Samson 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.
- Background: PubMed 24362795Samson 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Samson, Dr principal investigator
University of Geneva, Switzerland
David Sander, Prof study chair
University of Geneva, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Emotion Regulation Training in people with Neurodevelopmental Disorders, run by University of Geneva, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Positive and Negative Affect Scale (time frame: Week 1, Week 5, Week 9, Week 13 or 17). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02898298, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021.