NCT05820269

Brief Summary

Behavioral disorders and emotional disorders represent frequent reasons for consultation in young children. Their prevalence is between 7% and 13% depending on the studies. Behavioral disorders, and to a lesser extent emotional disorders, tend to persist through childhood and adolescence and are a risk factor for disorders in adulthood. There is still little research on psychotherapies concerning children and even less on parent(s)-young child therapies, despite a certain interest of clinicians for these. In a previous study, three independent factors appeared predictive of the unfavorable child's outcome : the frequency and intensity of behavioral problems and fears, as well as the absence of the father at more than 2/3 of the consultations. The only independent factor associated with the outcome of the mother was her anxiety score at the start of treatment. The study presented here will take these elements into account and will include an assessment of both parents. The main objective is to identify predictive factors of behavioural and emotional disorder outcome in children aged 18 months to 48 months after parent-child psychotherapy. The secondary objectives are to study predictive factors of the outcome in parents (anxiety/depression symptoms) and parent-child relationship. The main predictive factors will be the presence of the father at the consultations, the therapeutic alliance (subject to validation), the type of disorder of the child and the parental psychopathology.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
272

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2009

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2013

Completed
9.2 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 19, 2023

Completed
Last Updated

April 19, 2023

Status Verified

April 1, 2023

Enrollment Period

5 years

First QC Date

March 22, 2023

Last Update Submit

April 6, 2023

Conditions

Keywords

childhoodBehavioral DisordersEmotional Disorder of Childhood

Outcome Measures

Primary Outcomes (2)

  • predictive factors of behavioural disorder outcome

    The evolution of the child will be the total score of the CBCL (a z-score \< 1 will be considered as a favorable evolution).

    between inclusion and 18 months

  • predictive factors of emotional disorder outcome

    Parent-child relationships will be calculated by the PIR-GAS score. Relationship difficulties are assessed based on the intensity, frequency and duration of maladaptive interactions and a score below 40 indicates a disordered relationship.

    between inclusion and 18 months

Secondary Outcomes (1)

  • predictive factors of the outcome in parents (anxiety/depression symptoms) and parent-child relationship

    at 18 months

Interventions

filling out questionnaires during psychotherapy consultations

Eligibility Criteria

Age18 Months - 48 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

child with behavioral problems or emotional disorders consulting in a psychological care service

You may qualify if:

  • first medico-psychological consultation with a young child and one or both parents
  • child aged 18 to 48 months at the time of making the appointment for the first consultation
  • parents who can speak French
  • child presenting as a reason for consultation a behavioral and/or a emotional disorder (anger, opposition, provocation, aggressiveness, hyperactivity, agitation, fits of crying, separation difficulties, exaggerated fears, anxiety, sadness, shyness, withdrawal)
  • parents who signed the written consent
  • affiliation to a social security scheme

You may not qualify if:

  • child referred on therapeutic injunction by the judicial services
  • child seen only for a diagnostic opinion, with redirection to another service or private for pick-up if needed
  • presence of an adult other than the father or mother at the first consultation (apart from a mother-in-law or father-in-law)
  • child with a suspected or diagnosed pervasive developmental disorder (according to ICD10, F84 criteria),
  • suspicion or diagnosis of physical abuse
  • child with a sensory disability or mental retardation already diagnosed
  • child referred by a SESSAD, a CAMSP or an assessment center for pervasive disorders of the development

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UH of Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Marie-Joëlle Hervé, PHD

    UH of Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2023

First Posted

April 19, 2023

Study Start

January 5, 2009

Primary Completion

December 31, 2013

Study Completion

December 31, 2013

Last Updated

April 19, 2023

Record last verified: 2023-04

Locations