Last reviewed · How we verify
NCT06059092
Evaluation of Three School-based Mental Health Preventive Interventions in France
NA trial testing Adapt Module in Emotional Distress in 90 participants. Status unknown.
22 December 2023
Quick facts
| Lead sponsor | University of Nimes |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 90 |
| Start date | 6 November 2023 |
| Primary completion | 22 December 2023 |
| Estimated completion | 31 March 2024 |
| Sites | 2 locations across France |
Drugs / interventions tested
- Adapt Module
- Engage Module
- Interact Module
- Control Group — full drug profile →
Conditions studied
- Emotional Distress — all drugs for Emotional Distress →
- Functional Impairment — all drugs for Functional Impairment →
- Psychosocial Problem — all drugs for Psychosocial Problem →
- Wellbeing — all drugs for Wellbeing →
Sponsor
University of Nimes
Who can join
Adults 12 to 15, any sex, with Emotional Distress or Functional Impairment. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To meet adolescents' needs regarding mental health vulnerability, this study aims to propose and evaluate three original school-based preventive interventions delivered to French 13y-adolescents, with respect to their effects on mental health outcomes, as well as users' experiences of intervention, evaluated through questionnaires. Based on cognitive-behavioral therapies (CBT) techniques, these interventions target three strategic process areas: reactive adaptation, proactive adaptation, and interpersonal adaptation. Their effectiveness will be evaluated through a four-arm randomized controlled trial, conducted in an ecological context. Intra-group and inter-group comparisons will be carried out for our different variables of interest, namely targeted psychological processes, levels of distress, functional impairment, and well-being, and user experience indicators of acceptability, utility, and usability.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06059092
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University of Nimes trials
Trials by the same sponsor.
- NCT05791747 — Representations, Beliefs and Attitudes Towards Hypnosis in Patients Followed for Colorectal Cancer · unknown
- NCT04978194 — Effects of an Intervention on University Students' Mental Health and Learning During COVID-19 · NA · unknown
- NCT05019482 — Intervention Program Among University Student to Promote Physical Activity and Reduce the Sedentary Time · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06059092 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Nimes
- Last refreshed: 28 September 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06059092.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing