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

Parent-Child Relations Clinical Trial

— ECRIN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05206708
• Other study ID #: 2020/484
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2022
• Est. completion date: July 2026

Study information

• Verified date: December 2022
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Monika SZYMANSKA, PhD
• Phone: 003381219352
• Email: mszymanska[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 234
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Behavior Disorders
• Mental Disorders
• Parent-Child Relations

Intervention

Behavioral:
• Personalized psychotherapy
Strategy including personalized psychotherapy
• Standard of care
Strategy based standard intregrative psychodynamic therapy

Locations

Country	Name	City	State
France	CHU de Besançon	Besançon
France	CHU de Montpellier	Montpellier
France	GHU Paris Psychiatrie et Neurosciences	Paris
France	CHU de Reims	Reims

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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