Vulnerability/Resilience Factors Influencing the Developmental Trajectories and Adaptive Methods of Children and Adolescents in Child Welfare System. (EvolASE-PEA)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05525962 |
|
Recruitment Status :
Recruiting
First Posted : September 2, 2022
Last Update Posted : April 9, 2024
|
Sponsor:
University Hospital, Rouen
Information provided by (Responsible Party):
University Hospital, Rouen
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | June 23, 2022 | ||||||||
| First Posted Date | September 2, 2022 | ||||||||
| Last Update Posted Date | April 9, 2024 | ||||||||
| Actual Study Start Date | September 29, 2022 | ||||||||
| Estimated Primary Completion Date | September 29, 2027 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
|
||||||||
| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
|
||||||||
| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Vulnerability/Resilience Factors Influencing the Developmental Trajectories and Adaptive Methods of Children and Adolescents in Child Welfare System. | ||||||||
| Official Title | Facteurs de vulnérabilité/résilience influençant Les Trajectoires développementales et Les modalités Adaptatives d'Enfants et d'Adolescents confiés à l'Aide Sociale à l'Enfance. Cohorte Primo-arrivants. | ||||||||
| Brief Summary | Assess the prevalence of medico-psychological characteristics at the time of placement (M0), their appearance / disappearance and during the two years following placement (M12 and M24) by age group in children / adolescents in Child Protective Services and placed full-time in the structures of Seine-Maritime and Eure as well as in nursery in Le Havre or Rouen | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Minor (0 to 16 years old) arriving for the first time in child protective system and present full time | ||||||||
| Condition |
|
||||||||
| Intervention | Behavioral: questionnaries, scales, cognitive tests
A first interview is planned with a psycholgist in the weeks following the minor arrival in the structure (M0)
|
||||||||
| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
300 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | September 29, 2027 | ||||||||
| Estimated Primary Completion Date | September 29, 2027 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Sex/Gender |
|
||||||||
| Ages | up to 16 Years (Child) | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts |
|
||||||||
| Listed Location Countries | France | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT05525962 | ||||||||
| Other Study ID Numbers | 2021/0219/HP | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
|
||||||||
| IPD Sharing Statement | Not Provided | ||||||||
| Current Responsible Party | University Hospital, Rouen | ||||||||
| Original Responsible Party | Same as current | ||||||||
| Current Study Sponsor | University Hospital, Rouen | ||||||||
| Original Study Sponsor | Same as current | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators | Not Provided | ||||||||
| PRS Account | University Hospital, Rouen | ||||||||
| Verification Date | April 2024 | ||||||||