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

NCT ID: NCT05206708

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

234 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-28

Study Completion Date

2026-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Child Behavior Disorders Parent-Child Relations

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
117 dyads will be enrolled

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard care group

Standard psychodynamic therapy

Group Type ACTIVE_COMPARATOR

Standard of care

Intervention Type BEHAVIORAL

Strategy based standard intregrative psychodynamic therapy

Personalized care

Psychodynamic therapy or interactive guidance therapy

Group Type EXPERIMENTAL

Personalized psychotherapy

Intervention Type BEHAVIORAL

Strategy including personalized psychotherapy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Personalized psychotherapy

Strategy including personalized psychotherapy

Intervention Type BEHAVIORAL

Standard of care

Strategy based standard intregrative psychodynamic therapy

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Standard intregrative psychodynamic therapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lauriane Coady-Vulliez, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Besançon

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU de Besançon

Besançon, , France

Site Status RECRUITING

CHU de Montpellier

Montpellier, , France

Site Status NOT_YET_RECRUITING

GHU Paris Psychiatrie et Neurosciences

Paris, , France

Site Status NOT_YET_RECRUITING

CHU de Reims

Reims, , France

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Monika SZYMANSKA, PhD

Role: CONTACT

003381219352

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Monika SZYMANSKA, PhD

Role: primary

Marie Joelle HERVE, MD PhD

Role: primary

Romain DUGRAVIER, MD PhD

Role: primary

Anne Catherine ROLLAND, MD PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020/484

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.