Neurodevelopmental DisordersPEERS-MRNDNCT06612333
Evaluation of the French Version of the PEERS Social Skills Training Program for Adolescents With Rare Neurodevelopmental Disorders
An observational study of Neurodevelopmental Disorders and Rare Diseases, run by Imagine Institute at 1 site in France.
Trial summary
Adolescents and young adults with rare neurodevelopmental disorders are at risk of developing psychiatric pathologies during the transition to adulthood. Loneliness and lack of social relationships can lead to anxiety and depression in adolescents and young adults with rare neurodevelopmental disorders. Read more about this study
- Who is it for?
- Ages 12 to 30 years
- Conditions the study is for
- Neurodevelopmental Disorders, Rare Diseases
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2024to 17 Oct 2025
- Phase
- Observational
- 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 12 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study will focus on data from 40 patients with rare neurodevelopmental disorders and their 40 relatives/friends.
Who may be able to join
- Aged between 12 and 30 years, included at the start of the social skills program.
- Patients with rare neurodevelopmental diseases
- Patients benefiting from the social skills program
- Appropriate level of verbal elaboration
- Patient with a family member or a friend also participating in the social skills program
- Non-inclusion criteria :
Show all 9Show fewer
- Opposition of the patient or, if a minor, of his/her parents to participation in the study
- Patient not psychiatrically stabilized: acute symptoms of anxiety, depression, psychotic disorders.
- Severe intellectual disability
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site
Necker - Enfants Malades Hospital
Paris, Île-de-France Region, 75015
About this study
Official title: Evaluation of the French Version of the PEERS Social Skills Training Program for Adolescents With Rare Neurodevelopmental Disorders / PEERS-MRND
Adolescents and young adults with rare neurodevelopmental disorders are at risk of developing psychiatric pathologies during the transition to adulthood. Loneliness and lack of social relationships can lead to anxiety and depression in adolescents and young adults with rare neurodevelopmental disorders. Anxiety and depression are major risk factors for the transition to psychiatric symptoms in adulthood. The improvement of social skills and the positive evolution of social relationships in adolescents and young adults with rare neurodevelopmental disorders can lead to a reduction in the risk factors for anxiety and depression. It therefore seems essential to evaluate the evolution of social skills in this population of young adults under the care of the social skills program, PEERS, in France to assess the overall benefit of the program, particularly in this population of young people with rare neurodevelopmental disorders.
- Conditions
- Neurodevelopmental Disorders, Rare Diseases
- Medical subject headings
- Neurodevelopmental Disorders, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Inclusion criteria: * Aged between 12 and 30 years, included at the start of the social skills program. * Patients with rare neurodevelopmental diseases * Patients benefiting from the social skills program * Appropriate level of verbal elaboration * Patient with a family member or a friend also participating in the social skills program Non-inclusion criteria : * Opposition of the patient or, if a minor, of his/her parents to participation in the study * Patient not psychiatrically stabilized: acute symptoms of anxiety, depression, psychotic disorders. * Severe intellectual disability | |
| Family member or friend | Inclusion criteria: * be over 18 years * be a close relative or friend of a patient and share in his or her daily life * have taken or are taking the social skills program Non-inclusion criteria : - Opposition to participation in the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of social skills in adolescents and young adults with rare neurodevelopmental diseases participating in the social skills program
Quality of Play Questionnaire-Adolescent (QPQ-A) (QSQP in French)
Measured: 2023 - 2025
Assessment of social skills in adolescents and young adults with rare neurodevelopmental diseases
Friendship Quality Scale (FQS)
Measured: 2023 - 2025
Assessment of social skills in adolescents and young adults with rare neurodevelopmental diseases
Social Anxiety Scale for Adolescent (SAS-A)
Measured: 2023 - 2025
Assessment of social skills in adolescents and young adults with rare neurodevelopmental diseases
Loneliness and Social Dissatisfaction Scale (L\&SD)
Measured: 2023 - 2025
Assessment of social skills in adolescents and young adults with rare neurodevelopmental diseases
Test of Adolescent Social Skills Knowledge (TASSK)
Measured: 2023 - 2025
Assessment of social skills in adolescents and young adults with rare neurodevelopmental diseases
Self-Assessment of Conversational Skills (AHC)
Measured: 2023 - 2025
Assessment of social skills in adolescents and young adults with rare neurodevelopmental diseases
Beck Youth Inventories (BYI)
Measured: 2023 - 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start1 May 2024
- Primary completion17 Oct 2025
- Study completion17 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodevelopmental DisordersStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imagine Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612333
- Sponsor's protocol ID
- HJ-23-PEERS-MRND
- Acronym
- PEERS-MRND
- Status last verified
- Nov 2025
- First submitted
- 26 Apr 2024
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the French Version of the PEERS Social Skills Training Program for Adolescents With Rare Neurodevelopmental Disorders / PEERS-MRND
- ClinicalTrials.gov ID
- NCT06612333
- Acronym / sponsor ID
- PEERS-MRND / HJ-23-PEERS-MRND
- Conditions
- Neurodevelopmental Disorders, Rare Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Imagine InstituteUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 17 Oct 2025 (actual)
- Study completion
- 17 Oct 2025 (actual)
- First posted
- 25 Sep 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.
Adolescents and young adults with rare neurodevelopmental disorders are at risk of developing psychiatric pathologies during the transition to adulthood. Loneliness and lack of social relationships can lead to anxiety and depression in adolescents and young adults with rare neurodevelopmental disorders. Anxiety and depression are major risk factors for the transition to psychiatric symptoms in adulthood. The improvement of social skills and the positive evolution of social relationships in adolescents and young adults with rare neurodevelopmental disorders can lead to a reduction in the risk factors for anxiety and depression. It therefore seems essential to evaluate the evolution of social skills in this population of young adults under the care of the social skills program, PEERS, in France to assess the overall benefit of the program, particularly in this population of young people with rare neurodevelopmental disorders.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | – | –Inclusion criteria: * Aged between 12 and 30 years, included at the start of the social skills program. * Patients with rare neurodevelopmental diseases * Patients benefiting from the social skills program * Appropriate level of verbal elaboration * Patient with a family member or a friend also participating in the social skills program Non-inclusion criteria : * Opposition of the patient or, if a minor, of his/her parents to participation in the study * Patient not psychiatrically stabilized: acute symptoms of anxiety, depression, psychotic disorders. * Severe intellectual disability |
| Family member or friend | – | –Inclusion criteria: * be over 18 years * be a close relative or friend of a patient and share in his or her daily life * have taken or are taking the social skills program Non-inclusion criteria : - Opposition to participation in the study |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study will focus on data from 40 patients with rare neurodevelopmental disorders and their 40 relatives/friends.
Key inclusion criteria (9 listed)
- Aged between 12 and 30 years, included at the start of the social skills program.
- Patients with rare neurodevelopmental diseases
- Patients benefiting from the social skills program
- Appropriate level of verbal elaboration
- Patient with a family member or a friend also participating in the social skills program
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of social skills in adolescents and young adults with rare neurodevelopmental diseases participating in the social skills program
Time frame: 2023 - 2025
Quality of Play Questionnaire-Adolescent (QPQ-A) (QSQP in French)
Assessment of social skills in adolescents and young adults with rare neurodevelopmental diseases
Time frame: 2023 - 2025
Friendship Quality Scale (FQS)
Assessment of social skills in adolescents and young adults with rare neurodevelopmental diseases
Time frame: 2023 - 2025
Social Anxiety Scale for Adolescent (SAS-A)
Assessment of social skills in adolescents and young adults with rare neurodevelopmental diseases
Time frame: 2023 - 2025
Loneliness and Social Dissatisfaction Scale (L\&SD)
Assessment of social skills in adolescents and young adults with rare neurodevelopmental diseases
Time frame: 2023 - 2025
Test of Adolescent Social Skills Knowledge (TASSK)
Assessment of social skills in adolescents and young adults with rare neurodevelopmental diseases
Time frame: 2023 - 2025
Self-Assessment of Conversational Skills (AHC)
Assessment of social skills in adolescents and young adults with rare neurodevelopmental diseases
Time frame: 2023 - 2025
Beck Youth Inventories (BYI)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
Related trials for Neurodevelopmental Disorders
Active, not recruitingObservational study
Electrophysiologic Sleep Phenotyping and Sleep-Dependent Neuro-maturation in Clinical and Healthy Pediatric Populations
Healthy Children, Children With Neurodevelopmental Disorders
RecruitingObservational study
Motor Development and Early Predictors of Psychomotor Outcomes in Preterm and Term Infants Assessed by MOS-R and Caregiver Questionnaire at 18 and 36 Months
Neurodevelopmental Disorders, Motor Skills Disorders
RecruitingEarly Phase 1
Aprepitant for the Treatment of CLIFAHDD
CLIFAHDD, Congenital Contractures of the Limbs and Face, Hypotonia, and Developmental Delay
Active, not recruitingObservational study
Guangzhou Preterm and Term Birth Cohort Study
Preterm Birth, Neurodevelopmental Disorders
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurodevelopmental Disorders and Rare Diseases, run by Imagine Institute 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 9 inclusion and 0 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: finished, as of the sponsor's last update on 19 Nov 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of social skills in adolescents and young adults with rare neurodevelopmental diseases participating in the social skills program (time frame: 2023 - 2025). The study lists 7 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 19 Nov 2025; AzTrials last refreshed its copy on 8 Nov 2026.