NCT06088576

Brief Summary

Clinical experience has shown that adolescents have great difficulties in getting to mental health care centers. The investigators want to find a specific way to follow up with the adolescent public. This study sets up a digital mental health application offering a tele-consultation space, a chat space with mental health professionals, a forum space, a news and therapeutic education space. The objective of the study is to evaluate the acceptance of the digital tool by the adolescent between 11 and 18 years old. To do this, the investigators determine the number of connections to the tool during the 6 months of support.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2022

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2022

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

2.9 years

First QC Date

July 20, 2022

Last Update Submit

March 3, 2024

Conditions

Keywords

adolescentdigital mental health applicationdigital applicationtelepsychiatrytelemedecine

Outcome Measures

Primary Outcomes (2)

  • The number of connections to the application during the 6 months of support.

    The data tool will collect and count the number of connections on the application, the number of chat, video, phone call and like given to the news. The software CORTEXTE (digital patient record), will count the number of acts performed with the young person.

    Day 0 to Month 6

  • The quality of the interaction between the user and the application assessed by AttrakDiff 2.

    The Investigators use AttrakDiff 2, a validated self-assessment scale (Hassenzahl, Burmester and Kollet, 2003). It is consists in 28 items. Each item has 2 contrasting words (semantic differentiators), separated by a 7-point scale. The scale is divided into 7 pairs of words evaluating respectively: pragmatic aspects, the overall attractiveness of the interactive system, hedonic aspects - divided into two subscales: identification and stimulation. The purpose of this measure is to assess the global quality of the interaction between the user and the application.

    Month 3 and Month 6

Secondary Outcomes (8)

  • Behavioral disorders assessed by the score of Strengths and Difficulties Questionnaire(SDQ).

    Day 0, month 3, month 6, month 12

  • The level of impulsivity assessed by the score of Impulsivity scale " UPPS Impulsive Behavior Scale ".

    Day 0, month 3, month 6, month 12

  • Score of Self-esteem measurement scale (EMESA) to assess the adolescent's self-esteem.

    Day 0, month 3, month 6, month 12

  • Score of the DEP-ADO questionnaire to determine the addictions.

    Day 0, month 3, month 6, month 12

  • SDQ follow-up questionnaire

    Month 3 and Month 6

  • +3 more secondary outcomes

Study Arms (1)

test group

OTHER

Following the inclusion interview, adolescents has access to the Together application. During the duration of the support, he will have access to the news, chat and forum. Teenager have 8 working days to appropriate the application. For 1 month, the chat can be used without any other means of communication. A chat is limited to 20-30 minutes, after that, a teleconsultation can be offer. At the end of the 1 month, teleconsultations or a home visit are possible (30 to 45 minutes). They are done between 1 to 4 sessions in the month. Following the orientation, the psychologists take over the visio for the next 2 months, up to 2 to 4 interviews per month. Teleconsultation appointments are made on the calendar of the application by the professional after obtaining advice from teenagers. At the beginning of the 5th month of care, the professionals set up a mixed distance/presential care with the youth. They propose home visits, individual or group interviews on site.

Other: Together

Interventions

Tchat : limited to 20-30 minutes per day. With a member of the team Together. For teleconsultations : First teleconsultation, during the first month (1 to 4 sessions/month), are made by nurse and/or educator. After that, it is psychologists who do the teleconsultations (2 to 4 sessions/month). It's during 30 to 45 minutes. Home visits, individual or group interviews on site are possible after 4 month.

test group

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Aged 11 - 18 years old
  • Observation of mental suffering (ill-being, inappropriate behaviour, dropping out of school) following a medical, psychological or educational interview in the school, medical, paramedical, personal setting by a practitioner trained for this type of observation.
  • Have access to the Internet via smartphone and have a sufficient mastery of the tool (spoken and read French).
  • First-time arrivals on the sector who does not want management or dropout of care.
  • Not to be or no longer to be followed therapeutically by a psychologist or psychiatrist in the liberal or inter-sector.
  • Informed consent of the patient.

You may not qualify if:

  • Disabling Motor Disorders (Cerebral Motor Disability).
  • Heavy deficiency.
  • Infant psychosis with strong relationship problems. .
  • Withdrawal of care without degradation of the psychic state. .
  • Is not in the pole 93I03 ( EPS Ville-Evrard).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Etablissement Public de Santé de Ville-Evrard

Neuilly-sur-Marne, 93330, France

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Central Study Contacts

Rusheentira Thavaseelan

CONTACT

Mathilde Pistre

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: The group consists of teenagers between 11 and 18 years old, recruited by professionals of medical-psychological center, Child Protection, school medicine college and high school as well as pediatric emergencies. The group will have access to the digital mental health application for 6 months. Assessments will take place at different times.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of clinical research unit

Study Record Dates

First Submitted

July 20, 2022

First Posted

October 18, 2023

Study Start

June 30, 2022

Primary Completion

June 1, 2025

Study Completion

June 30, 2025

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations