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

Primary Purpose

Child Behavior Disorders, Parent-Child Relations

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Personalized psychotherapy
Standard of care
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Child Behavior Disorders

Eligibility Criteria

undefined - 3 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de BesançonRecruiting
  • CHU de Montpellier
  • GHU Paris Psychiatrie et Neurosciences
  • CHU de Reims

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard care group

Personalized care

Arm Description

Standard psychodynamic therapy

Psychodynamic therapy or interactive guidance therapy

Outcomes

Primary Outcome Measures

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"

Secondary Outcome Measures

Full Information

First Posted
January 10, 2022
Last Updated
December 6, 2022
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT05206708
Brief Title
Assesment of the Efficacy of Personalized Parent-child Psychotherapy in Children Under 3 Years Old
Acronym
ECRIN
Official Title
Assesment of the Efficacy of Personalized Parent-child Psychotherapy Evaluating Symptoms in Children Under 3 Years Old and Parent-child Interaction.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2022 (Actual)
Primary Completion Date
July 2026 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Behavior Disorders, Parent-Child Relations

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
117 dyads will be enrolled
Allocation
Randomized
Enrollment
234 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard care group
Arm Type
Active Comparator
Arm Description
Standard psychodynamic therapy
Arm Title
Personalized care
Arm Type
Experimental
Arm Description
Psychodynamic therapy or interactive guidance therapy
Intervention Type
Behavioral
Intervention Name(s)
Personalized psychotherapy
Intervention Description
Strategy including personalized psychotherapy
Intervention Type
Behavioral
Intervention Name(s)
Standard of care
Other Intervention Name(s)
Standard intregrative psychodynamic therapy
Intervention Description
Strategy based standard intregrative psychodynamic therapy
Primary Outcome Measure Information:
Title
Efficacy of therapy
Description
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"
Time Frame
Month 4

10. Eligibility

Sex
All
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monika SZYMANSKA, PhD
Phone
003381219352
Email
mszymanska@chu-besancon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauriane Coady-Vulliez, MD
Organizational Affiliation
CHU Besançon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Besançon
City
Besançon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monika SZYMANSKA, PhD
Email
mszymanska@chu-besancon.fr
First Name & Middle Initial & Last Name & Degree
Lauriane VULLIEZ-COADY, MD PhD
Facility Name
CHU de Montpellier
City
Montpellier
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Joelle HERVE, MD PhD
Email
mj-herve@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Marie Joelle HERVE, MD PhD
Facility Name
GHU Paris Psychiatrie et Neurosciences
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Romain DUGRAVIER, MD PhD
Email
r.dugravier@ghu-paris.fr
First Name & Middle Initial & Last Name & Degree
Romain DUGRAVIER, MD PhD
Facility Name
CHU de Reims
City
Reims
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Catherine ROLLAND, MD PhD
Email
acrolland@chu-reims.fr
First Name & Middle Initial & Last Name & Degree
Anne Catherine ROLLAND, MD PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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