Evaluating personalized psychotherapy for young children with behavior issues
Assesment of the Efficacy of Personalized Parent-child Psychotherapy Evaluating Symptoms in Children Under 3 Years Old and Parent-child Interaction.
NA · Centre Hospitalier Universitaire de Besancon · NCT05206708
This study is testing a new personalized therapy for young children with behavior issues to see if it works better than standard therapy for improving their symptoms and family interactions.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 234 (estimated) |
| Ages | N/A to 3 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Besancon (other) |
| Locations | 4 sites (Besançon and 3 other locations) |
| Trial ID | NCT05206708 on ClinicalTrials.gov |
What this trial studies
This study assesses the effectiveness of a personalized parent-child psychotherapy approach compared to standard psychodynamic integrative therapy for children under three years old with behavioral problems. Evaluations will be conducted before treatment, at the end of treatment, and one year later to measure improvements in children's symptoms, parent-infant interaction quality, parental competencies, and the parent-therapist alliance. Additionally, hair cortisol concentration will be analyzed to gauge stress levels. The goal is to determine if personalized therapy leads to better outcomes than standard care.
Who should consider this trial
Good fit: Ideal candidates are families seeking help for functional or behavioral issues in children under three years old.
Not a fit: Patients who may not benefit include those with severe untreated psychiatric disorders, children with autism spectrum disorder, or families already receiving care.
Why it matters
Potential benefit: If successful, this approach could significantly improve behavioral outcomes for young children and enhance parent-child relationships.
How similar studies have performed: While there is ongoing research in child psychotherapy, this personalized approach specifically for very young children is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Besançon and 3 other locations
- 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)
Study contacts
- Principal investigator: Lauriane Coady-Vulliez, MD — CHU Besançon
- Study coordinator: Monika SZYMANSKA, PhD
- Email: mszymanska@chu-besancon.fr
- Phone: 003381219352
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Child Behavior Disorders, Parent-Child Relations