Child Behavior DisordersECRINNCT05206708
Assesment of the Efficacy of Personalized Parent-child Psychotherapy in Children Under 3 Years Old
A study testing Personalized psychotherapy in people with Child Behavior Disorders and Parent-Child Relations, run by Centre Hospitalier Universitaire de Besancon at 4 sites in France.
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 Read more about this study
- Who is it for?
- Ages Up to 3 years
- Conditions the study is for
- Child Behavior Disorders, Parent-Child Relations
- What is being tested?
- Personalized psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 4 sitesFrance
- Study dates
- 28 Feb 2022to Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Families who are requesting a consultation for functional or behavioural problems of their child
- Children under the age of 3
Who cannot join
- Parents suffering from a severe untreated psychiatric disorder
- Difficulties in speaking French
- Children with Autistic spectrum disorder
- Families already in care
Trial locations and contacts
4 sites in 1 country.
France4 sites, 4 recruiting
- Recruiting
CHU de Besançon
Besançon
Monika SZYMANSKA, PhD, mszymanska@chu-besancon.fr
Lauriane VULLIEZ-COADY, MD PhD
- Not yet recruiting
CHU de Montpellier
Montpellier
Marie Joelle HERVE, MD PhD, mj-herve@chu-montpellier.fr
Marie Joelle HERVE, MD PhD
- Not yet recruiting
GHU Paris Psychiatrie et Neurosciences
Paris
Romain DUGRAVIER, MD PhD, r.dugravier@ghu-paris.fr
Romain DUGRAVIER, MD PhD
- Not yet recruiting
CHU de Reims
Reims
Anne Catherine ROLLAND, MD PhD, acrolland@chu-reims.fr
Anne Catherine ROLLAND, MD PhD
About this study
Official title: Assesment of the Efficacy of Personalized Parent-child Psychotherapy Evaluating Symptoms in Children Under 3 Years Old and Parent-child Interaction.
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
- Conditions
- Child Behavior Disorders, Parent-Child Relations
- Being tested
- Personalized psychotherapy, Standard of care
- Medical subject headings
- Child Behavior Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized psychotherapyBehavioural
Strategy including personalized psychotherapy
Standard of careBehavioural
Also called Standard intregrative psychodynamic therapy
Strategy based standard intregrative psychodynamic therapy
| Study group | Role | What they receive |
|---|---|---|
| Standard care group | Active comparator | Standard psychodynamic therapy Receives: Behavioral: Standard of care |
| Personalized care | Experimental | Psychodynamic therapy or interactive guidance therapy Receives: Behavioral: Personalized psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: Month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start28 Feb 2022
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Behavior DisordersStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lauriane Coady-Vulliez, MD, Principal investigator, CHU Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206708
- Sponsor's protocol ID
- 2020/484
- Acronym
- ECRIN
- Status last verified
- Sep 2024
- First submitted
- 10 Jan 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assesment of the Efficacy of Personalized Parent-child Psychotherapy Evaluating Symptoms in Children Under 3 Years Old and Parent-child Interaction.
- ClinicalTrials.gov ID
- NCT05206708
- Acronym / sponsor ID
- ECRIN / 2020/484
- Conditions
- Child Behavior Disorders, Parent-Child Relations
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 25 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care group | Active comparator | Behavioral: Standard of careStandard psychodynamic therapy |
| Personalized care | Experimental | Behavioral: Personalized psychotherapyPsychodynamic therapy or interactive guidance therapy |
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Families who are requesting a consultation for functional or behavioural problems of their child
- Children under the age of 3
Key exclusion criteria (4 listed)
- Parents suffering from a severe untreated psychiatric disorder
- Difficulties in speaking French
- Children with Autistic spectrum disorder
- Families already in care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized psychotherapyStrategy including personalized psychotherapy | Behavioural | Personalized care |
| Standard of careAlso: Standard intregrative psychodynamic therapyStrategy based standard intregrative psychodynamic therapy | Behavioural | Standard care group |
Primary outcome
Efficacy of therapy
Time frame: Month 4
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"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauriane Coady-Vulliez, MD principal investigator
CHU Besançon
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized psychotherapy in people with Child Behavior Disorders and Parent-Child Relations, run by Centre Hospitalier Universitaire de Besancon at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Monika SZYMANSKA, PhD (003381219352, mszymanska@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of therapy (time frame: Month 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.