Prader-Willi SyndromeAPT-WILLNCT06279052
Adolescent Projections During Transition in Prader-Willi Syndrome
A study testing Phone interview in people with Prader-Willi Syndrome, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Single-center, cross-sectional qualitative study seeking to collect the experience of adolescence and the transition to adulthood of people affected by Prader-Willi syndrome in a population. Read more about this study
- Who is it for?
- Ages 15 to 20 years
- Conditions the study is for
- Prader-Willi Syndrome
- What is being tested?
- Phone interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2024to 1 Dec 2024
- 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 15 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with genetically confirmed Prader-Willi syndrome
- Patients affiliated or beneficiaries of a social security system
- Patients known and followed by the reference center, presenting sufficient intellectual skills to answer the interview questions
Who cannot join
- Refusal of family participation (if minor)
- Refusal of participation by the patient or his guardian (if of legal age)
Trial locations and contacts
1 site in 1 country.
France1 site
CHU de Toulouse
Toulouse
Grégoire BENVEGNU, benvegnu.g@chu-toulouse.fr
Dalil Benkanoun, dalil.benkanoun@hotmail.fr
About this study
Official title: What Projections Towards the Future During a Period of Transition? A Qualitative Study of Adolescents With Prader-Willi Syndrome
Single-center, cross-sectional qualitative study seeking to collect the experience of adolescence and the transition to adulthood of people affected by Prader-Willi syndrome in a population. To do this, the present will carry out a qualitative study with a reflexive thematic analysis of the data collected through semi-structured interviews using an interview guide.
- Conditions
- Prader-Willi Syndrome
- Being tested
- Phone interview
- Medical subject headings
- Prader-Willi Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone interviewBehavioural
Phone interview during which the experience of the transition to adulthood among adolescents and young adults with Prader Willi Syndrome will be retrieved
| Study group | Role | What they receive |
|---|---|---|
| Phone interview | Experimental | Patients will then be contacted by the investigator to arrange a telephone appointment date.
On the day of the telephone appointment, the psychiatry intern will call the patient to conduct the interview which will last between 30 and 60 minutes.
At the end of the telephone interview, the patient's participation in the research will end. Receives: Behavioral: Phone interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experience of the disease and aspirations regarding the future
The main objective of this study is to explore their experience of the disease and their aspirations regarding their future in a population of older adolescents and young adults with Prader-Willi syndrome. A questionnaire created by the clinical investigator containing personal questions will be applied to all patients. There is no scale.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prader-Willi SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Grégoire BENVEGNU, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279052
- Sponsor's protocol ID
- RC31/23/0535
- Acronym
- APT-WILL
- Status last verified
- Feb 2024
- First submitted
- 14 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- 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 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Projections Towards the Future During a Period of Transition? A Qualitative Study of Adolescents With Prader-Willi Syndrome
- ClinicalTrials.gov ID
- NCT06279052
- Acronym / sponsor ID
- APT-WILL / RC31/23/0535
- Conditions
- Prader-Willi Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 26 Feb 2024 (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.
Single-center, cross-sectional qualitative study seeking to collect the experience of adolescence and the transition to adulthood of people affected by Prader-Willi syndrome in a population. To do this, the present will carry out a qualitative study with a reflexive thematic analysis of the data collected through semi-structured interviews using an interview guide.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phone interview | Experimental | Behavioral: Phone interviewPatients will then be contacted by the investigator to arrange a telephone appointment date. On the day of the telephone appointment, the psychiatry intern will call the patient to conduct the interview which will last between 30 and 60 minutes. At the end of the telephone interview, the patient's participation in the research will end. |
Who may qualify
- Ages
- 15 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients with genetically confirmed Prader-Willi syndrome
- Patients affiliated or beneficiaries of a social security system
- Patients known and followed by the reference center, presenting sufficient intellectual skills to answer the interview questions
Key exclusion criteria (2 listed)
- Refusal of family participation (if minor)
- Refusal of participation by the patient or his guardian (if of legal age)
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 |
|---|---|---|
| Phone interviewPhone interview during which the experience of the transition to adulthood among adolescents and young adults with Prader Willi Syndrome will be retrieved | Behavioural | Phone interview |
Primary outcome
Experience of the disease and aspirations regarding the future
Time frame: 1 hour
The main objective of this study is to explore their experience of the disease and their aspirations regarding their future in a population of older adolescents and young adults with Prader-Willi syndrome. A questionnaire created by the clinical investigator containing personal questions will be applied to all patients. There is no scale.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Prader-Willi Syndrome
RecruitingPhase 2
A Study of CSTI-500 in Patients With Prader-Willi Syndrome
Prader-Willi Syndrome
Recruiting
Cerebellar TMS and Satiety in Prader-Willi Syndrome
Prader-Willi Syndrome
Enrolling by invitationObservational study
Observational Study of VYKAT™ XR in Patients With Prader-Willi Syndrome
Prader-Willi Syndrome
Active, not recruitingPhase 1/2
A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment
Hypothalamic Obesity, Prader-Willi Syndrome
Active, not recruiting
Impact of Bright Light Therapy on Prader-Willi Syndrome
Prader-Willi Syndrome, Excessive Daytime Sleepiness
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.
Grégoire BENVEGNU principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phone interview in people with Prader-Willi Syndrome, run by University Hospital, Toulouse 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 3 inclusion and 2 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 28 Feb 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 Grégoire BENVEGNU (05 34 55 86 78 ext. +33, benvegnu.g@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experience of the disease and aspirations regarding the future (time frame: 1 hour). 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 28 Feb 2024.