NCT06612333

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 25, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2025

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

1.5 years

First QC Date

April 26, 2024

Last Update Submit

November 18, 2025

Conditions

Outcome Measures

Primary Outcomes (7)

  • 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)

    2023 - 2025

  • Assessment of social skills in adolescents and young adults with rare neurodevelopmental diseases

    Friendship Quality Scale (FQS)

    2023 - 2025

  • Assessment of social skills in adolescents and young adults with rare neurodevelopmental diseases

    Social Anxiety Scale for Adolescent (SAS-A)

    2023 - 2025

  • Assessment of social skills in adolescents and young adults with rare neurodevelopmental diseases

    Loneliness and Social Dissatisfaction Scale (L\&SD)

    2023 - 2025

  • Assessment of social skills in adolescents and young adults with rare neurodevelopmental diseases

    Test of Adolescent Social Skills Knowledge (TASSK)

    2023 - 2025

  • Assessment of social skills in adolescents and young adults with rare neurodevelopmental diseases

    Self-Assessment of Conversational Skills (AHC)

    2023 - 2025

  • Assessment of social skills in adolescents and young adults with rare neurodevelopmental diseases

    Beck Youth Inventories (BYI)

    2023 - 2025

Study Arms (2)

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

Eligibility Criteria

Age12 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study will focus on data from 40 patients with rare neurodevelopmental disorders and their 40 relatives/friends.

You may qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necker - Enfants Malades Hospital

Paris, Île-de-France Region, 75015, France

Location

MeSH Terms

Conditions

Neurodevelopmental DisordersRare Diseases

Condition Hierarchy (Ancestors)

Mental DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2024

First Posted

September 25, 2024

Study Start

May 1, 2024

Primary Completion

October 17, 2025

Study Completion

October 17, 2025

Last Updated

November 19, 2025

Record last verified: 2025-11

Locations