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

Assesment of the Efficacy of Personalized Parent-child Psychotherapy Evaluating Symptoms in Children Under 3 Years Old and Parent-child Interaction.

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

Study Overview

• Status: Recruiting
• Conditions: Parent-Child Relations; Child Behavior Disorders
• Intervention / Treatment: Behavioral: Standard of care; Behavioral: Personalized psychotherapy

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 Type: Interventional
• Enrollment (Anticipated): 234
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Monika SZYMANSKA, PhD; Phone Number: 003381219352; Email: mszymanska@chu-besancon.fr

Study Locations

• France
  • Besançon, France
    • Recruiting
    • CHU de Besancon
    • Contact: Monika SZYMANSKA, PhD; Email: mszymanska@chu-besancon.fr
    • Principal Investigator: Lauriane VULLIEZ-COADY, MD PhD
  • Montpellier, France
    • Not yet recruiting
    • CHU de Montpellier
    • Contact: Marie Joelle HERVE, MD PhD; Email: mj-herve@chu-montpellier.fr
    • Principal Investigator: Marie Joelle HERVE, MD PhD
  • Paris, France
    • Not yet recruiting
    • GHU Paris Psychiatrie et Neurosciences
    • Contact: Romain DUGRAVIER, MD PhD; Email: r.dugravier@ghu-paris.fr
    • Principal Investigator: Romain DUGRAVIER, MD PhD
  • Reims, France
    • Not yet recruiting
    • CHU de Reims
    • Contact: Anne Catherine ROLLAND, MD PhD; Email: acrolland@chu-reims.fr
    • Principal Investigator: Anne Catherine ROLLAND, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of therapy	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"	Month 4

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Investigators: Principal Investigator: Lauriane Coady-Vulliez, MD, CHU Besançon

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2022
• Primary Completion (Anticipated): July 1, 2026
• Study Completion (Anticipated): July 1, 2026

Study Registration Dates

• First Submitted: January 10, 2022
• First Submitted That Met QC Criteria: January 24, 2022
• First Posted (Actual): January 25, 2022

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurodevelopmental Disorders; Mental Disorders; Child Behavior Disorders
• Other Study ID Numbers: 2020/484

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No