Mental HealthTOGETHERNCT06088576
Using a Digital Application for Adolescents in Dropout of Care in Mental Health : Facilitate the Return in Classic Care With Telepsychiatry, Tchats, Forums and a Home Medical Team.
A study testing Together in people with Mental Health, run by Dominique JANUEL at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Mental Health
- What is being tested?
- Together
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jun 2022to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Etablissement Public de Santé de Ville-Evrard
Neuilly-sur-Marne, 93330
Rusheentira Thavaseelan, +33 1 43 09 32 32, r.thavaseelan@epsve.fr
+33 1 43 09 32 32
About this study
Official title: Using a Digital Mental Health Application in the Adolescent's Care Pathway.
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.
Read the detailed description
The purpose of the CPP application is the creation of an innovative psychiatric device combining a digital application of mental health for adolescents with a mobile team, anchored within the I03 pole of the Public Health Establishment of Ville-Evrard.
This Together digital application includes a space for news, chat, peer-to-peer forum and video consultation. We propose an action-research protocol because this project was born of questions related to the terrain raising the problem of the difficulty of access to the care of adolescents in the territory of Pole 93I03.
Action research is aimed at adolescents aged 11 to 18, whose medical, paramedical and school partners have observed mental suffering (ill-being, inappropriate behaviour, dropping out of school) but who are not or no longer enrolled in mental care. It aims to use a digital application backed by a mobile team to improve access to the mental health care system for adolescents.
The research issue would be formalized in these terms: would the Together mental health application, combined with a mobile team, allow access to a path of care for the adolescent?
HYPOTHESIS We hypothesize that adolescents will accept the digital tool, using it regularly and that this will ultimately facilitate access to mental care.
OBJECTIVES The main objective of this study is to assess the acceptance of the digital tool by the young person. Acceptance here depends on the regular use of the Together app by the teenager. The secondary objectives are to assess the percentage of adolescents starting face-to-face management within sector structures; the percentage of adolescents observing a better-be, to observe the quality of the support via the dual device digital application/mobile team.
METHOD The action-research takes place over a year, with a panel of 50 teenagers. After a pre-inclusion interview by the partners to talk about the research-action device to the teenager, he is offered an inclusion interview informing him of the research, the consent and the use of the digital application. Different evaluations are then spent at different times of action research to evaluate the main objective and secondary objectives.
- Conditions
- Mental Health
- Being tested
- Together
- Keywords
- adolescent, digital mental health application, digital application, telepsychiatry, telemedecine
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TogetherOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Together |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Month 3 and Month 6
Secondary outcomes (8)
Behavioral disorders assessed by the score of Strengths and Difficulties Questionnaire(SDQ).
The self-administered questionnaire, validate by Goodman, 2015, for adolescents aged 11 to 16 consists of 25 questions to assess behavioral and adjustment problems in 5 main areas: emotional problems, behavioral problems, hyperactivity, relationship problems, and pro-social qualities.
Measured: Day 0, month 3, month 6, month 12
The level of impulsivity assessed by the score of Impulsivity scale " UPPS Impulsive Behavior Scale ".
This scale (validated by Whiteside and Lynam, 2001) assesses impulsivity in adolescents, based on 4 components of impulsivity and 45 questions: urgency, lack of premeditation, lack of persistence and sensation seeking. If you put Absolutely, then it correspond to 1, if you just agree it correspond to 2, if you disagree it correspond to 3 and if you strongly disagree it is 4. Scoring is done so that a high score on a subscale corresponds to a higher level impulsivity => scores are obtained for Urgency, Lack of Premeditation, Lack of Perseverance, and Sensation Search.
Measured: Day 0, month 3, month 6, month 12
Score of Self-esteem measurement scale (EMESA) to assess the adolescent's self-esteem.
This scale (validated by Kindelberger, Picherit, 2015) assesses adolescent self-esteem based on 5 areas of satisfaction: family, peers, schooling, professionalism and physical appearance.
Measured: Day 0, month 3, month 6, month 12
Score of the DEP-ADO questionnaire to determine the addictions.
This grid is used to screen adolescents aged 11 to 17 for problematic alcohol and drug use. It is a questionnaire structured in 7 items, with a score that can range from 0 to greater than 17. A score of 0 to 8: no intervention, 9 to 16: intervention desirable, greater than 17: intervention necessary.
Measured: Day 0, month 3, month 6, month 12
SDQ follow-up questionnaire
Questionnaire to determine whether the intervention solved or reduced the problems, whether the intervention was beneficial in making the problems more acceptable.
Measured: Month 3 and Month 6
The level of therapeutic alliance assessed by the score of Therapeutic Alliance Questionnaire (CALPAS-T)
Evaluates the therapeutic alliance from the patient's point of view, according to four sub-scales: the patient's capacity for work, his commitment to therapy, the patient-therapist consensus on the work strategy, the therapist's involvement and understanding. The scale has 24 items, each rated from 0 to 7.
Measured: Month 3 and Month 6
Score of Patient satisfaction Questionnaire (CSQ) to assess patient satisfaction.
This questionnaire collects the patient's opinion on its management.The questionnaire consists of 8 items, each rated from 1 to 4. Scores can range from 8 to 32. From 8 to 20, the level of satisfaction is low, from 21 to 26, the level is medium and from 27 to 32, the level of satisfaction is high.
Measured: Month 6
Semi-structured interviews
Done by assessors, other than those who will be performing the clinical assessment between T1 T2 and T3, using the RA interview guide to assess the subjective perception of the patient's mental suffering. Every professional on the team was trained in the methodology of the semi-directive interview.
Measured: Day 0, Month 3 and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start30 Jun 2022
- Primary completion1 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dominique JANUEL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dominique JANUEL, Centre hospitalier de Ville-Evrard, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088576
- Sponsor's protocol ID
- 2022-A00722-41
- Acronym
- TOGETHER
- Status last verified
- Mar 2024
- First submitted
- 20 Jul 2022
- Last updated
- 5 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Digital Mental Health Application in the Adolescent's Care Pathway.
- ClinicalTrials.gov ID
- NCT06088576
- Acronym / sponsor ID
- TOGETHER / 2022-A00722-41
- Conditions
- Mental Health
- Keywords
- adolescent, digital mental health application, digital application, telepsychiatry, telemedecine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Dominique JANUELUniversity, hospital or other
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of the CPP application is the creation of an innovative psychiatric device combining a digital application of mental health for adolescents with a mobile team, anchored within the I03 pole of the Public Health Establishment of Ville-Evrard.
This Together digital application includes a space for news, chat, peer-to-peer forum and video consultation. We propose an action-research protocol because this project was born of questions related to the terrain raising the problem of the difficulty of access to the care of adolescents in the territory of Pole 93I03.
Action research is aimed at adolescents aged 11 to 18, whose medical, paramedical and school partners have observed mental suffering (ill-being, inappropriate behaviour, dropping out of school) but who are not or no longer enrolled in mental care. It aims to use a digital application backed by a mobile team to improve access to the mental health care system for adolescents.
The research issue would be formalized in these terms: would the Together mental health application, combined with a mobile team, allow access to a path of care for the adolescent?
HYPOTHESIS We hypothesize that adolescents will accept the digital tool, using it regularly and that this will ultimately facilitate access to mental care.
OBJECTIVES The main objective of this study is to assess the acceptance of the digital tool by the young person. Acceptance here depends on the regular use of the Together app by the teenager. The secondary objectives are to assess the percentage of adolescents starting face-to-face management within sector structures; the percentage of adolescents observing a better-be, to observe the quality of the support via the dual device digital application/mobile team.
METHOD The action-research takes place over a year, with a panel of 50 teenagers. After a pre-inclusion interview by the partners to talk about the research-action device to the teenager, he is offered an inclusion interview informing him of the research, the consent and the use of the digital application. Different evaluations are then spent at different times of action research to evaluate the main objective and secondary objectives.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| test group | Other | Other: TogetherFollowing 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. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TogetherTchat : 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. | Other | test group |
Primary outcome
The number of connections to the application during the 6 months of support.
Time frame: Day 0 to Month 6
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.
The quality of the interaction between the user and the application assessed by AttrakDiff 2.
Time frame: Month 3 and Month 6
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.
8 secondary outcomes
Behavioral disorders assessed by the score of Strengths and Difficulties Questionnaire(SDQ).
Time frame: Day 0, month 3, month 6, month 12
The level of impulsivity assessed by the score of Impulsivity scale " UPPS Impulsive Behavior Scale ".
Time frame: Day 0, month 3, month 6, month 12
Score of Self-esteem measurement scale (EMESA) to assess the adolescent's self-esteem.
Time frame: Day 0, month 3, month 6, month 12
Score of the DEP-ADO questionnaire to determine the addictions.
Time frame: Day 0, month 3, month 6, month 12
SDQ follow-up questionnaire
Time frame: Month 3 and Month 6
The level of therapeutic alliance assessed by the score of Therapeutic Alliance Questionnaire (CALPAS-T)
Time frame: Month 3 and Month 6
Score of Patient satisfaction Questionnaire (CSQ) to assess patient satisfaction.
Time frame: Month 6
Semi-structured interviews
Time frame: Day 0, Month 3 and Month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Together in people with Mental Health, run by Dominique JANUEL at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rusheentira Thavaseelan (+33 1 43 09 32 32, r.thavaseelan@epsve.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of connections to the application during the 6 months of support. (time frame: Day 0 to Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.