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RecruitingNCT05206708ECRINUpdated Sep 19, 2024

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

An interventional study of Personalized psychotherapy and Standard of care in Child Behavior Disorders and Parent-Child Relations, sponsored by Centre Hospitalier Universitaire de Besancon. Recruiting at 4 sites in France. Open to participants aged Up to 3 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Centre Hospitalier Universitaire de Besancon · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Feb 2022; still recruiting 4 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
234
Allocation
Randomized
Ages
Up to 3 Years
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Child Behavior Disorders
  • Parent-Child Relations
03

In context

Child Behavior Disorders

35 studies on the registry are indexed under Child Behavior Disorders; 10 are open to participants now.

This study's planned enrollment of 234 is above the median of 134 across 25 interventional studies indexed under Child Behavior Disorders.

Browse Child Behavior Disorders studies →

Lead sponsor

Centre Hospitalier Universitaire de Besancon is the lead sponsor of 450 studies on the registry; 97 are open to participants now.

Browse Centre Hospitalier Universitaire de Besancon studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 3 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Parents suffering from a severe untreated psychiatric disorder
  • Difficulties in speaking French
  • Children with Autistic spectrum disorder
  • Families already in care
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
234 participants (estimated)

Study arms

  • Active comparator
    Standard care group

    Standard psychodynamic therapy

    Behavioral: Standard of care

  • Experimental
    Personalized care

    Psychodynamic therapy or interactive guidance therapy

    Behavioral: Personalized psychotherapy

Interventions

  • BehavioralPersonalized psychotherapy

    Strategy including personalized psychotherapy

  • BehavioralStandard of care

    Strategy based standard intregrative psychodynamic therapy

    Also known as: Standard intregrative psychodynamic therapy

06

What researchers measure

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"

    Time frame: Month 4

07

Study locations

1 of 4 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2022 (actual). Primary completion is estimated for Aug 2026, 54 months after the start.

Of 16 interventional studies with no phase under Child Behavior Disorders, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 86. This study's planned 54 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 10, 2022
First posted
Jan 25, 2022
StartActual
Feb 28, 2022
Primary completionEst.
Aug 2026
CompletionEst.
Aug 2026
Last update
Sep 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05206708
Lead sponsor
Centre Hospitalier Universitaire de Besancon
Responsible party
Sponsor
First posted
Jan 25, 2022
Start date
Feb 28, 2022
Primary completion
Aug 2026 (estimated)
Completion
Aug 2026 (estimated)
Last update
Sep 19, 2024

Study contacts

Monika SZYMANSKA, PhD
Contact
mszymanska@chu-besancon.fr
003381219352
Lauriane Coady-Vulliez, MD
principal investigator · CHU Besançon

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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