Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05820269 |
| Other study ID # |
8301 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 5, 2009 |
| Est. completion date |
December 31, 2013 |
Study information
| Verified date |
April 2023 |
| Source |
University Hospital, Montpellier |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
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.
Most studies have shown a significant association between these early childhood disorders and
a parent-child relationship disorder, as well as the presence of depressive symptoms in the
mother.
Other risk factors include environmental, child and parenting factors.
Several types of therapeutic intervention have been developed in recent decades to treat the
difficulties of young children, their common point being to work jointly with the child and
the parents and to focus on the parent-child relationship.
From the many studies carried out, we can retain the greatest difficulty in treating
behavioral disorders, compared to emotional disorders or functional disorders.
Even if the therapies have shown their effectiveness, a certain number of children continue
to present difficulties after the treatment.
The factors most often found associated with poorer progress are the intensity of the child's
disorders, the child's advanced age, the presence of parental psychopathology and negative
life events.
In young children, other studies are needed to better understand the factors involved in the
failure or success of therapy and in particular to determine whether these are the same
factors as in older children.
Several early childhood clinicians have insisted on the need for an alliance so that
therapeutic work can take place. In particular, they underlined the importance of developing
empathy and a positive affective bond between the therapist and the parents. Despite its
recognized clinical interest, the therapeutic alliance (or working alliance) has been the
subject of little research in populations of young children.
The "Working Alliance Inventory" is a scale measuring the therapeutic alliance differentiates
three components: the bond, the tasks and the objectives
In a previous study, three independent factors appeared predictive of the unfavorable future
of the child: 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 main
outcome is the Child Beavior Check list (CBCL) total score change.
The secondary objectives are to study predictive factors of the outcome in parents
(anxiety/depression symptoms) and parent-child relationship.
Outcomes will be assessed by comparing the pre- and post-therapy scores of a battery of
questionnaires that assess the child's symptoms, the parents' anxiety/depression, and the
parent-child relationship. Multivariate linear regression analysis will be used to identify,
among the studied variables (child age and sex, socio-economic status, life events, disorder
type, intensity and duration, social support, parents' psychopathology, parents' attachment,
parent-child relationships, therapy length and frequency, father's involvement in the
therapy, and therapeutic alliance), predictive factors of the outcomes.
