- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07334704
Effects of Implementing a Program to Develop Emotional Skills and Post-traumatic Growth in Adolescents and Young Adults Receiving Child Welfare Services-a Pilot Study in the Haute-Loire Department (JEMotion43)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mathieu PEREIRA
- Phone Number: +33 04.71.50.34.55
- Email: Recherche.enfance@hauteloire.fr
Study Contact Backup
- Name: Marie PEURIERE
- Phone Number: +33 04.71.04.35.38
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Minors: > 15 to < 18 years old:
- Be taken in or accompanied by a child protection service.
- Have given informed consent to participate in the study.
- Have obtained authorization from those with parental authority.
Young adults aged ≥ 18 to 21:
- Have signed a young adult contract (CJM) with the Child Welfare Service (ASE).
- Have given their informed consent to participate in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
Participation in a structured 6-week program focused on emotional skills development and psychoeducation on post-traumatic growth (JEMotion43 program).
|
completion of all questionnaires :
Programm JEMotion : 6-week emotional skills development and psychoeducation program. It consists of 8 modules of 2 hours each. The program is structured around a variety of activities based on pedagogical and experiential principles. It includes enriching emotional vocabulary, identifying emotional components, and exploring their functional value. |
|
Active Comparator: Control Group
Use, over the same period, of a mobile app promoting mental health (WeCare / Care Island).
|
completion of all questionnaires :
Mobile app promoting mental health for teens aged 14 to 17. It is a gamified, self-guided 6-week digital program (about 1 hour per week), incorporating techniques from cognitive behavioral therapy, positive psychology, and lifestyle medicine. The game offers a narrative journey through an imaginary world consisting of six islands, each corresponding to a health and well-being theme: physical activity, stress management, sleep, addictive behaviors, emotional regulation, automatic thoughts, and self-compassion. Side quests also address balanced eating and the integration of positive psychology practices into everyday life. The player takes on the role of a hero accompanied by their guide, tasked with restoring the vital balance of the islands threatened by pollution and destruction. The player must clean up the islands, recycle waste into seeds, regenerate nature, and interact with totem animals, which impart psychoeducational lessons related to mental health. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emotional Competence
Time Frame: Baseline and 6 months
|
score assessed by Emotional Skills Profile.
45 items from this instrument assess the management of one's own emotions.
15 subscale covers five skills : identifying, understanding, expressing, regulating, and using emotions, over 3 targets : self / others / context Each item is rated on a 5-point Likert scale.
The total ESP score ranges from 45 to 225 (45 items rated from 1 to 5) and reflects the overall level of emotional skills, with a low score indicating poorly developed skills, a medium score indicating adequate emotional functioning, and a high score indicating good abilities to identify, express, regulate, and use emotions.
|
Baseline and 6 months
|
|
post-traumatic growth
Time Frame: Baseline and 6 months
|
Score assessed by Posttraumatic Growth Inventory (PTGI) This 21-item questionnaire measures perceived positive psychological changes following adversity. It covers five dimensions: relationships with others, personal strength, new possibilities, spiritual changes, and appreciation of life. The score is calculated by adding up the scores for the 21 items (rated from 0 = no change to 5 = very significant change), giving a total score between 0 and 105. Subscale scores can also be obtained by adding up the items corresponding to each of the five dimensions. A low score indicates little perceived positive change after the event, a moderate score indicates partial growth, and a high score indicates significant positive psychological transformation. |
Baseline and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychological distress
Time Frame: Baseline, 1 week before intervention and 6 months
|
Psychological distress will be measured using the French version of the Kessler Brief Symptom Inventory (K6).
This 6-item self-report questionnaire assesses the frequency of nonspecific emotional distress symptoms (e.g., feeling "nervous" or "despairing") over the past 30 days.
Responses are given on a 5-point scale indicating frequency (from "Never" to "All the time").
To calculate the score, responses are rated from 0 to 4, generating a total score ranging from 0 to 24, where a higher score indicates greater distress.
|
Baseline, 1 week before intervention and 6 months
|
|
Mental well-being
Time Frame: Baseline, 1 week before intervention and 6 months
|
Mental well-being will be assessed using the Warwick-Edinburgh Mental Well-Being Scale.The total WEMWBS score ranges from 14 to 70 and reflects the overall level of mental well-being, with a low score indicating reduced well-being, a medium score indicating moderate well-being, and a high score indicating significant and positive mental well-being.
|
Baseline, 1 week before intervention and 6 months
|
|
executive functions
Time Frame: Baseline, 1 week before intervention and 6 months
|
The Behavioral Rating Inventory of Executive Functions is a self-assessment questionnaire for executive functions.
It comprises 75 items assessing 9 areas of executive functions.
The total score is expressed as a T-score (mean 50, standard deviation 10) and reflects the overall level of executive functioning, with a T-score ≥ 65 indicating significant difficulties, T 60-64 indicating a borderline area, and T < 60 indicating average executive functioning.
|
Baseline, 1 week before intervention and 6 months
|
|
Attention
Time Frame: Baseline, 1 week before intervention and 6 months
|
The Attention Assessment Tests score is summarized by standardized scores or percentiles for each domain (sustained, divided, selective attention, and motor inhibition), reflecting overall attentional performance, where high scores indicate adequate attention and executive control, and low scores reveal specific difficulties in one or more aspects of attention.
|
Baseline, 1 week before intervention and 6 months
|
|
working memory
Time Frame: Baseline, 1 week before intervention and 6 months
|
The ARITHMETIC and NUMBER MEMORY subtests of the Wechsler Adult Intelligence Scale can be used to assess working memory.
The Working Memory Index, based on the Arithmetic and Number Memory subtests, is expressed as a standard score (mean 100, standard deviation 15 for the overall index, or 10/3 for the subtests) and reflects working memory capacity, where a low score indicates difficulties in maintaining and manipulating information, an average score indicates expected functioning, and a high score indicates above-average working memory.
|
Baseline, 1 week before intervention and 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mathieu PEREIRA, Université Lumière Lyon 2
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RIPH3_PEREIRA_JEMotion43
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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