Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Early Detection of Mental Disorders in Adolescents With Chronic Pain: Creation of a Screening Tool for Use by the General Practitioner (REPERADO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04467229
Recruitment Status : Not yet recruiting
First Posted : July 10, 2020
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
This research aims to create a tool for detection of mental health disorders in adolescents with chronic pain. The first part is testing a screening questionnaire and comparing in with existing questionnaires. The second part involves two focus group with the adolescents aimed at recording their perception of the questionnaire.

Condition or disease Intervention/treatment Phase
Chronic Pain Mental Disorder Behavioral: Focus group Not Applicable

Detailed Description:

First part : creation of a screening tool. After detailed interviews with chronic pain experts and bibliographic research, a screening tool for mental disorders in chronically painful adolescents has been designed for use by the general practitioner. This tool is composed of 10 questions, making up a score of 10 points. The tool will be compared to two screening tools used in different clinical contexts, the HAD scale and the RPPS scale, in order to determine a positivity threshold. There is only one center participating in the research, the Centre de la Douleur et de la migraine de l'hôpital Trousseau (Trousseau Hospital Pain Center). Parents' consent is required for participation. For this assessment, the adolescents (between 10 and 18 years old) that see a doctor at the Centre de la douleur, will be asked to fill up the questionnaires in the waiting room. The filling of the questionnaire takes a few minutes. At the end of the appointment, the doctor will read the questionnaire to check that all elements have been addressed during the appointment.

Second part : focus group on the questionnaire: 5 to 10 adolescents will participate in a discussion group lead by a paediatrician and a psychologist from the Centre de la Douleur de Trousseau. Two groups will be organized, the length of the group discussion being one hour. These focus groups will explore the adolescents' perception of the questionnaire and of different elements of the screening. The group will undergo full transcription. The verbatim will be anonymous and will be analysed through qualitative methods.

The data will help designing a guidebook for the clinician explaining the main points in screening for mental disorders in chronic pain adolescent patients.

A validation study for the screening tool will be eventually carried out after the completion of this preliminary study.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Early Detection of Mental Disorders in Adolescents With Chronic Pain: Creation of a Screening Tool for Use by the General Practitioner
Estimated Study Start Date : July 6, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Focus group with chronically painful adolescents
Adolescents with chronic pain
Behavioral: Focus group
5 to 10 adolescents will participate in a discussion group lead by a paediatrician and a psychologist from the Centre de la Douleur de Trousseau. Two groups will be organized, the length of the group discussion being one hour. These focus groups will explore the adolescents' perception of the questionnaire and of different elements of the screening. The group will undergo full transcription. The verbatim will be anonymous and will be analysed through qualitative methods.




Primary Outcome Measures :
  1. Screening questionnaire score [ Time Frame: Baseline visit ]
    A new Screening questionnaire elaborated beforehand by the study will be answered by patients in order to detect psychological suffering in chronically painful adolescents The screening questionnaire consists in 10 items (yes/no response format)


Secondary Outcome Measures :
  1. Hospital Anxiety and Depression (HAD) score [ Time Frame: Baseline visit ]
    Patients complete a Hospital Anxiety and Depression (HAD) scale questionnaire

  2. Pediatric Pain Screening Tool (PPST) score [ Time Frame: Baseline visit ]
    Patients complete a Pediatric Pain Screening Tool questionnaire

  3. Participants feedback [ Time Frame: up to 3 months upon recuitment ]
    Focus group questions will provide descriptions of patients' experiences with the questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patient from 10 to 18 years old
  • chronic pain (existing for more than 3 months or longer than tissue repair time)
  • first consultation in the service
  • Collection of the written consent of the holders of parental authority and agreement of the adolescent
  • Adolescents able to understand the questionnaire and the purpose of the study
  • Affiliation to a social security scheme or beneficiary

Exclusion Criteria:

Exclusion Criteria :

  • Decompensated physical or psychological pathology requiring urgent medical treatment
  • Heavy psychological pathology preventing the adolescent's understanding of the study
  • Patient benefiting from State Medical Aid

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04467229


Contacts
Layout table for location contacts
Contact: Alexandra LOISEL, PH 01 71 73 85 47 loisel.alexandra@aphp.fr
Contact: Barbara TOURNIAIRE, ph 01 71 73 89 19 barbara.tourniaire@aphp.fr

Locations
Layout table for location information
France
Centre de la douleur et de la migraine-Hôpital Trousseau
Paris, France, 75012
Contact: Alexandra LOISEL, PH    01 71 73 85 47    loisel.alexandra@aphp.fr   
Contact: Barbara TOURNIAIRE, PH    01 71 73 89 19    barbara.tourniaire@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Layout table for investigator information
Principal Investigator: Alexandra LOISEL Assistance Publique - Hôpitaux de Paris
Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04467229    
Other Study ID Numbers: APHP200623
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Chronic Pain
Mental Disorders
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Chronic Pain
Mental Disorders
Psychotic Disorders
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Schizophrenia Spectrum and Other Psychotic Disorders