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

NCT05206708 | Recruiting

• 1 other identifier: 2020/484
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 4

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

Conditions

Child Behavior Disorders; Parent-Child Relations

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Standard care group

ACTIVE COMPARATOR

Standard psychodynamic therapy

Behavioral: Standard of care

Personalized care

EXPERIMENTAL

Psychodynamic therapy or interactive guidance therapy

Behavioral: Personalized psychotherapy

Interventions

Personalized psychotherapy BEHAVIORAL

Strategy including personalized psychotherapy

Personalized care

Standard of care BEHAVIORAL

Strategy based standard intregrative psychodynamic therapy

Also known as: Standard intregrative psychodynamic therapy

Standard care group

Eligibility Criteria

• Age: Up to 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Families who are requesting a consultation for functional or behavioural problems of their child
• Children under the age of 3

You may not qualify if:

• Parents suffering from a severe untreated psychiatric disorder
• Difficulties in speaking French
• Children with Autistic spectrum disorder
• Families already in care

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (4)

CHU de Besançon

Besançon, France

RECRUITING

CHU de Montpellier

Montpellier, France

NOT YET RECRUITING

GHU Paris Psychiatrie et Neurosciences

Paris, France

NOT YET RECRUITING

CHU de Reims

Reims, France

NOT YET RECRUITING

MeSH Terms

Conditions

Child Behavior Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Lauriane Coady-Vulliez, MD

  CHU Besançon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monika SZYMANSKA, PhD

CONTACT

003381219352; mszymanska@chu-besancon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 117 dyads will be enrolled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 25, 2022
• Study Start: February 28, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)