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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Paris, France
        • Centre Hospitalier Sainte Anne
      • Picauville, France
        • Fondation Bon Sauveur De La Manche
      • Saint-Denis, France
        • Centre Hospitalier de Saint Denis
    • Essone
      • Grigny, Essone, France
        • EPSM Barthélémy Durand
    • Guadeloupe
      • Saint-Claude, Guadeloupe, France
        • EPSM de Guadeloupe
    • Pas De Calais
      • La Couture, Pas De Calais, France
        • EPSM Val de Lys
      • Vieille chapelle, Pas De Calais, France
        • EPSM Val de Lys

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Questionnaires at the start and end of the school year
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:
  • Questionnaires at the start and end of the school year completed by teachers and directors
  • Questionnaire before and after intervention completed by teachers and parents.
  • Questionnaires during and after the intervention, completed by public mental health professionals

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GCS pour la recherche et la formation en sante mentale

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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