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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Pain; Mental Disorder
• Intervention / Treatment: Behavioral: Focus group

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexandra LOISEL, PH; Phone Number: 01 71 73 85 47; Email: loisel.alexandra@aphp.fr
• Study Contact Backup: Name: Barbara TOURNIAIRE, PH; Phone Number: 01 71 73 89 19; Email: barbara.tourniaire@aphp.fr

Study Locations

• France
  • Paris, France, 75012
    • Centre de la douleur et de la migraine-Hôpital Trousseau
    • Contact: Alexandra LOISEL, PH; Phone Number: 01 71 73 85 47; Email: loisel.alexandra@aphp.fr
    • Contact: Barbara TOURNIAIRE, PH; Phone Number: 01 71 73 89 19; Email: barbara.tourniaire@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 16 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Screening questionnaire score	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)	Baseline visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Anxiety and Depression (HAD) score	Patients complete a Hospital Anxiety and Depression (HAD) scale questionnaire	Baseline visit
Pediatric Pain Screening Tool (PPST) score	Patients complete a Pediatric Pain Screening Tool questionnaire	Baseline visit
Participants feedback	Focus group questions will provide descriptions of patients' experiences with the questionnaire	up to 3 months upon recuitment

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Alexandra LOISEL, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Anticipated): July 6, 2020
• Primary Completion (Anticipated): September 30, 2020
• Study Completion (Anticipated): September 30, 2020

Study Registration Dates

• First Submitted: May 25, 2020
• First Submitted That Met QC Criteria: July 8, 2020
• First Posted (Actual): July 10, 2020

Study Record Updates

• Last Update Posted (Actual): July 10, 2020
• Last Update Submitted That Met QC Criteria: July 8, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Chronic Pain; Mental Disorders
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Schizophrenia Spectrum and Other Psychotic Disorders; Disease; Psychotic Disorders; Chronic Pain; Mental Disorders
• Other Study ID Numbers: APHP200623

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No