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ECRIN: Assesment of the Efficacy of Personalized Parent-child Psychotherapy in Children Under 3 Years Old

Sponsor
Centre Hospitalier Universitaire de Besancon (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05206708
Collaborator
(none)
234
Enrollment
4
Locations
2
Arms
53.9
Anticipated Duration (Months)
58.5
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to assess the efficacy at 4 months of a personalized strategy comparatively to a standard Psychodynamic Integrative Therapy, on childrens' symptom improvment

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Personalized psychotherapy
  • Behavioral: Standard of care
 N/A

Detailed Description

3 evaluations are performed: before treatment, at the end of the treatment and one year after the treatment.

evaluations include assessment of: children's symptom parent-infant interaction quality parental competencies parental perception of the child by his/her parent parent-therapist alliance hair cortisol concentration

Study Design

Study Type:
Interventional
Anticipated Enrollment :
234 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
117 dyads will be enrolled
Primary Purpose:
Treatment
Official Title:
Assesment of the Efficacy of Personalized Parent-child Psychotherapy Evaluating Symptoms in Children Under 3 Years Old and Parent-child Interaction.
Anticipated Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2026
Anticipated Study Completion Date :
Jul 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Standard care group

Standard psychodynamic therapy

Behavioral: Standard of care
Strategy based standard intregrative psychodynamic therapy
Other Names:
  • Standard intregrative psychodynamic therapy

    		•
    Experimental: Personalized care

    Psychodynamic therapy or interactive guidance therapy

    Behavioral: Personalized psychotherapy
    Strategy including personalized psychotherapy

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy of therapy [Month 4]

      To assess the efficacy at 4 months of a personalized strategy by Interactive Guidance or Psychodynamic Therapy, comparatively to a standard Psychodynamic Therapy, on child symptoms assessed with the "Symptom Check List"

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 3 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Families who are requesting a consultation for functional or behavioural problems of their child

    • Children under the age of 3

    Exclusion Criteria:

    • Parents suffering from a severe untreated psychiatric disorder

    • Difficulties in speaking French

    • Children with Autistic spectrum disorder

    • Families already in care

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU de Besançon Besançon France
    2 CHU de Montpellier Montpellier France
    3 GHU Paris Psychiatrie et Neurosciences Paris France
    4 CHU de Reims Reims France

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire de Besancon

    Investigators

    • Principal Investigator: Lauriane Coady-Vulliez, MD, CHU Besançon

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire de Besancon
    ClinicalTrials.gov Identifier:
    NCT05206708
    Other Study ID Numbers:
    • 2020/484
    First Posted:
    Jan 25, 2022
    Last Update Posted:
    Jan 25, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Mental Disorders
    Child Behavior Disorders

    Study Results

    No Results Posted as of Jan 25, 2022