Ignite Creation Date:
2025-12-24 @ 11:11 PM
Ignite Modification Date:
2025-12-25 @ 8:44 PM
Study NCT ID:
NCT05820269
Status:
COMPLETED
Last Update Posted:
2023-04-19
First Post:
2023-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Predictive Factors for the Outcome of Young Children Emotional and/or Behavioral Disorders After Psychotherapeutic Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 272}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2013-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-06', 'studyFirstSubmitDate': '2023-03-22', 'studyFirstSubmitQcDate': '2023-04-06', 'lastUpdatePostDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'predictive factors of behavioural disorder outcome', 'timeFrame': 'between inclusion and 18 months', 'description': 'The evolution of the child will be the total score of the CBCL (a z-score \\< 1 will be considered as a favorable evolution).'}, {'measure': 'predictive factors of emotional disorder outcome', 'timeFrame': 'between inclusion and 18 months', 'description': 'Parent-child relationships will be calculated by the PIR-GAS score.\n\nRelationship difficulties are assessed based on the intensity, frequency and duration of maladaptive interactions and a score below 40 indicates a disordered relationship.'}], 'secondaryOutcomes': [{'measure': 'predictive factors of the outcome in parents (anxiety/depression symptoms) and parent-child relationship', 'timeFrame': 'at 18 months', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['childhood', 'Behavioral Disorders', 'Emotional Disorder of Childhood'], 'conditions': ['Behavioral Disorders', 'Emotional Disorder of Childhood']}, 'descriptionModule': {'briefSummary': "Behavioral disorders and emotional disorders represent frequent reasons for consultation in young children.\n\nTheir 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.\n\nThere 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.\n\nIn 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.\n\nThe study presented here will take these elements into account and will include an assessment of both parents.\n\nThe 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.\n\nThe 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.", 'detailedDescription': 'Behavioral disorders and emotional disorders represent frequent reasons for consultation in young children.\n\nTheir 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.\n\nThere 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.\n\nMost 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.\n\nOther risk factors include environmental, child and parenting factors.\n\nSeveral 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.\n\nFrom the many studies carried out, we can retain the greatest difficulty in treating behavioral disorders, compared to emotional disorders or functional disorders.\n\nEven if the therapies have shown their effectiveness, a certain number of children continue to present difficulties after the treatment.\n\nThe 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.\n\nIn 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.\n\nSeveral 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.\n\nThe "Working Alliance Inventory" is a scale measuring the therapeutic alliance differentiates three components: the bond, the tasks and the objectives\n\nIn 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.\n\nThe study presented here will take these elements into account and will include an assessment of both parents.\n\nThe 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.\n\nThe secondary objectives are to study predictive factors of the outcome in parents (anxiety/depression symptoms) and parent-child relationship.\n\nOutcomes 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '48 Months', 'minimumAge': '18 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'child with behavioral problems or emotional disorders consulting in a psychological care service', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* first medico-psychological consultation with a young child and one or both parents\n* child aged 18 to 48 months at the time of making the appointment for the first consultation\n* parents who can speak French\n* 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)\n* parents who signed the written consent\n* affiliation to a social security scheme\n\nExclusion Criteria:\n\n* child referred on therapeutic injunction by the judicial services\n* child seen only for a diagnostic opinion, with redirection to another service or private for pick-up if needed\n* presence of an adult other than the father or mother at the first consultation (apart from a mother-in-law or father-in-law)\n* child with a suspected or diagnosed pervasive developmental disorder (according to ICD10, F84 criteria),\n* suspicion or diagnosis of physical abuse\n* child with a sensory disability or mental retardation already diagnosed\n* child referred by a SESSAD, a CAMSP or an assessment center for pervasive disorders of the development'}, 'identificationModule': {'nctId': 'NCT05820269', 'briefTitle': 'Predictive Factors for the Outcome of Young Children Emotional and/or Behavioral Disorders After Psychotherapeutic Intervention', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'InterventionPredictive Factors for the Outcome of Emotional and/or Behavioural Disorders in 18- to 48 Month-old Children After Psychotherapeutic Intervention', 'orgStudyIdInfo': {'id': '8301'}}, 'armsInterventionsModule': {'interventions': [{'name': 'parents-child psychotherapy', 'type': 'BEHAVIORAL', 'description': 'filling out questionnaires during psychotherapy consultations'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'UH of Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Marie-Joëlle Hervé, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UH of Montpellier'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}