- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04300712
Partnerships Between Schools and Public Mental Health Departments: Investigation of Multi-professional Interventions for Children Aged 3 to 8 With Mental Health Issues (Parpsych-Ed) (Parpsych-Ed)
March 6, 2020 updated by: GCS pour la recherche et la formation en sante mentale
Partnerships Between Schools and Public Mental Health Departments: Investigation of Multi-professional Interventions for Children Aged 3 to 8 With Mental Health Issues (Parpsych-Ed).
Local partnerships between schools (preschool and elementary) and mental health public services are implemented in seven sites in France.
They aim to improve recognition of difficulties related to mental health problems and to provide interventions to 3 to 8 years-old pupils in need.
Our hypothesis that these local partnerships and interventions enhance the role of school in supporting good mental health and wellbeing of all children and the trajectories of children with mental health service needs.
Theses also facilitate community support.
One of them, early-interventions involve caregivers.
Our objective is to enhance knowledge of the unmet mental healthcare need at school and to explore for whom, in which local context and how partnerships and early intervention work.
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
Teachers are legitimately concerned about children that encounter mental health problems.
Mental healthcare might be indicated.
Because of internal and external barriers of treatment, they could remain inaccessible for many children in need.
School staff should not try to diagnose conditions.
However, collaborative interventions delivered by school and mental healthcare staffs in association with other stakeholders as parents and associations should ensure clear systems and processes in place for identifying possible mental health problems and support children and their parents.
Local partnership and early interventions will be elaborated within focus groups bringing together all stakeholders and will be experimented in 7 French sites (preschool, primary school and local public health service) thereafter.
These complex interventions will be evaluated through mixed-methods including qualitative case studies and a pragmatic trial.
This feasibility study will produce a set of findings that will permit to argue conceptual framework of partnership and early intervention, to provide guidelines to implement these in France considering children needs, local context, all stakeholders acceptance and public health efficacy.
Study Type
Interventional
Enrollment (Anticipated)
2000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sandrine Bonneton, MD
- Phone Number: 0033157278458
- Email: bonnetonsandrine@gmail.com
Study Locations
-
-
-
Paris, France
- Centre hospitalier Sainte Anne
-
Contact:
- Marie-Odile Perouse de MontClos, MD
- Email: perousedemontclos@ch-sainte-anne.fr
-
Sub-Investigator:
- Yann Cross, MD
-
Picauville, France
- Fondation Bon Sauveur de la Manche
-
Contact:
- Justine Levaillant
- Email: justine.levaillant@fbs50.fr
-
Saint-Denis, France
- Centre Hospitalier de Saint Denis
-
Contact:
- Jean-Pierre Benoit
- Email: jeanpierre.benoit@ch-stdenis.fr
-
-
Essone
-
Grigny, Essone, France
- EPSM Barthélémy Durand
-
-
Guadeloupe
-
Saint-Claude, Guadeloupe, France
- EPSM de Guadeloupe
-
Contact:
- Caroll Devaux, MD
- Email: caroll.devaux@epsm-guadeloupe.fr
-
-
Pas De Calais
-
La Couture, Pas De Calais, France
- EPSM Val de Lys
-
Contact:
- Laurent Lauwerier, MD
- Email: llauwerier@epsm-stvenant.fr
-
Vieille chapelle, Pas De Calais, France
- EPSM Val de Lys
-
Contact:
- Laurent Lauwerier, MD
- Email: llauwerier@epsm-stvenant.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 8 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Attending pre- and elementary schools involved in the ParpsychEd partnerships.
Exclusion Criteria:
- Absence of parents and/or child consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Tracking of the children with difficulties
All parents and teachers will respond to the questionnaires and the beginning and end of school year which is not done in the routine for tracking the children in difficulty.
|
Interventions will be proposed to children identified in a worrisome situation.
The Strengths and Difficulties.
Questionnaire will be used by teachers to score these situations.
The recognition process of mental health problem and need continue with responses.
Responses are supporting a graduated response process in school and facilitating external support when needed (mental health services, community supports).
Early intervention is one of all responses, which involve caregivers.
Responses to worrisome situations aim to improve schooling conditions, to acknowledge mental health problems or condition and the health services need for children.
To evaluate the intervention, the impact supplement of SDQ and the follow-up questions will be used by the teachers and the parents of children who benefit of the intervention.
The interventions will be experimented during year 2020-21.
Children might benefit of them from several weeks to one year, according to their need.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of 3 to 8 years old children identified with mental health services need
Time Frame: 24 months
|
Evolution of the number of 3 to 8 years old children identified with mental health services
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Strengths and Difficulties Questionnaire (SDQ)
Time Frame: 12 months
|
Changes in the impact supplement and the follow-up questions - parents and teachers
|
12 months
|
Healthcare access, barriers to treatment, intervention acceptance
Time Frame: 12 months
|
Healthcare access, barriers to treatment, intervention acceptance
|
12 months
|
Parent refusal rate to let their child benefit of all responses
Time Frame: 12 months
|
Parent refusal rate to let their child benefit of all responses
|
12 months
|
Parent refusal rate to let their child benefit of the early intervention
Time Frame: 12 months
|
Parent refusal rate to let their child benefit of the early intervention
|
12 months
|
Parents refusal rate to plan appointment in public health services as indicated after the intervention
Time Frame: 18 months
|
Parents refusal rate to plan appointment in public health services as indicated after the intervention
|
18 months
|
Mental health and mental health services representation and use
Time Frame: 18 months
|
Changes in the mental health representations of parents, teachers and others professionnals
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Jean-Luc Roelandt, MD, French World Health Organization Collaborating Centre for Research and Training in Mental Health
- Principal Investigator: Sandrine Bonneton, MD, French World Health Organization Collaborating Centre for Research and Training in Mental Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 1, 2020
Primary Completion (Anticipated)
December 31, 2021
Study Completion (Anticipated)
December 31, 2021
Study Registration Dates
First Submitted
May 10, 2019
First Submitted That Met QC Criteria
March 6, 2020
First Posted (Actual)
March 9, 2020
Study Record Updates
Last Update Posted (Actual)
March 9, 2020
Last Update Submitted That Met QC Criteria
March 6, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- Parpsych-Ed_2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on School Difficulties Associated With Mental Health Problems
-
Duke UniversityNational Institute of Mental Health (NIMH)CompletedDepression | Anxiety | Psychological Distress | Borderline Personality Disorder | Problems With Emotion Regulation | Difficulties Coping With Negative EmotionsUnited States
-
Tuscaloosa Research & Education Advancement CorporationVA Office of Research and Development; US Department of Veterans Affairs; Tuscaloosa...CompletedHealth Behavior | Problems With Access to Health CareUnited States
-
Ottawa Hospital Research InstituteCanadian Institutes of Health Research (CIHR); Ontario Ministry of Health and...Completed
-
Iowa Adaptive Technologies, Inc.National Institute of Nursing Research (NINR)CompletedProblems With Access to Health Care
-
Al-Azhar UniversityCompleted
-
AccareRecruitingBehavioral Symptoms | Behavior Problems | Behavioral Problems | Disruptive Behavior | Problem Behaviors | Behavioral DifficultiesNetherlands
-
King Edward Medical UniversityCompletedSchool Mental Health Training of TeachersPakistan
-
Yale UniversityNational Institute of Mental Health (NIMH)CompletedSchool-based Mental Health Treatment ServicesUnited States
-
THIM - die internationale Hochschule für PhysiotherapieVrije Universiteit BrusselCompletedHealthy Volunteers | Persons With no Known Significant Health ProblemsSwitzerland
-
AccareRecruitingBehavioral Problem of Child | Behavioral DifficultiesNetherlands
Clinical Trials on Questionnaires at the start and end of the school year
-
University Hospital, GhentCompleted
-
Novindiet ClinicTehran University of Medical Sciences; University of NottinghamCompletedOverweight | Type 2 Diabetes | ObeseIran, Islamic Republic of
-
GCS Ramsay Santé pour l'Enseignement et la RechercheCompletedSurgery | Hallux ValgusFrance
-
Novindiet ClinicTehran University of Medical Sciences; University of NottinghamCompletedOverweight | Type 2 Diabetes | ObeseIran, Islamic Republic of
-
Memorial Sloan Kettering Cancer CenterTerminatedThe Families or Next of Kin of Patients Treated at MSKCC for Non-cutaneous Squamous Cell Carcinomas of the | Upper Aerodigestive TractUnited States
-
Technical University of MunichLudwig-Maximilians - University of MunichEnrolling by invitationChildhood CancerGermany
-
Rajiv Gandhi Cancer Institute & Research Center...Completed
-
Assistance Publique - Hôpitaux de ParisNational Reference Center (NRC) for Chlamydia infections, UMR1181CompletedGenital Chlamydia Trachomatis InfectionFrance
-
National Defense Medical Center, TaiwanRecruitingBreastfeeding | Pregnant Woman | Maternal CompetenceTaiwan
-
University of ValenciaCompletedPalliative CareSpain