Behavioral DisordersNCT05820269
Predictive Factors for the Outcome of Young Children Emotional and/or Behavioral Disorders After Psychotherapeutic Intervention
An observational study of Behavioral Disorders and Emotional Disorder of Childhood, run by University Hospital, Montpellier at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 48 months
- Conditions the study is for
- Behavioral Disorders, Emotional Disorder of Childhood
- What is being tested?
- parents-child psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 272 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jan 2009to 31 Dec 2013
- Phase
- Observational
- 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 18 to 48 months
- All sexes
- No healthy volunteers
- Child
Study population: child with behavioral problems or emotional disorders consulting in a psychological care service
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: InterventionPredictive Factors for the Outcome of Emotional and/or Behavioural Disorders in 18- to 48 Month-old Children After Psychotherapeutic Intervention
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.
Read more
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.
Read the detailed 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.
- Being tested
- parents-child psychotherapy
- Keywords
- childhood, Behavioral Disorders, Emotional Disorder of Childhood
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parents-child psychotherapyBehavioural
filling out questionnaires during psychotherapy consultations
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: between inclusion and 18 months
Secondary outcomes (1)
predictive factors of the outcome in parents (anxiety/depression symptoms) and parent-child relationship
validate the IT-WAI-S (Infant-Toddler Working Alliance Inventory short version, a therapeutic alliance assessment tool, translated in French from the Working alliance Inventory and adapted to early consultations
Measured: at 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start5 Jan 2009
- Primary completion31 Dec 2013
- Study completion31 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavioral DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Joëlle Hervé, PHD, Principal investigator, UH of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820269
- Sponsor's protocol ID
- 8301
- Status last verified
- Apr 2023
- First submitted
- 22 Mar 2023
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- InterventionPredictive Factors for the Outcome of Emotional and/or Behavioural Disorders in 18- to 48 Month-old Children After Psychotherapeutic Intervention
- ClinicalTrials.gov ID
- NCT05820269
- Acronym / sponsor ID
- 8301
- Keywords
- childhood, Behavioral Disorders, Emotional Disorder of Childhood
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 5 Jan 2009 (actual)
- Primary completion
- 31 Dec 2013 (actual)
- Study completion
- 31 Dec 2013 (actual)
- First posted
- 19 Apr 2023 (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.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 48 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- child with behavioral problems or emotional disorders consulting in a psychological care service
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| parents-child psychotherapyfilling out questionnaires during psychotherapy consultations | Behavioural | – |
Primary outcome
predictive factors of behavioural disorder outcome
Time frame: between inclusion and 18 months
The evolution of the child will be the total score of the CBCL (a z-score < 1 will be considered as a favorable evolution).
predictive factors of emotional disorder outcome
Time frame: between inclusion and 18 months
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.
1 secondary outcome
predictive factors of the outcome in parents (anxiety/depression symptoms) and parent-child relationship
Time frame: at 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
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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.
Marie-Joëlle Hervé, PHD principal investigator
UH of Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Behavioral Disorders and Emotional Disorder of Childhood, run by University Hospital, Montpellier at 1 site 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
predictive factors of behavioural disorder outcome (time frame: between inclusion and 18 months). The study lists 2 primary outcomes in all. 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 Apr 2023.