Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT01085305
Status:
COMPLETED
Last Update Posted:
2016-09-15
First Post:
2010-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effectiveness of Parent-Child Interaction Therapy (PCIT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000096865', 'term': 'Oppositional Defiant Disorder'}, {'id': 'D019955', 'term': 'Conduct Disorder'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-14', 'studyFirstSubmitDate': '2010-03-10', 'studyFirstSubmitQcDate': '2010-03-10', 'lastUpdatePostDateStruct': {'date': '2016-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eyberg Child Behavior Inventory (ECBI)', 'timeFrame': 'Pre intervention, 6 months, 18 months', 'description': 'ECBI is taken at study entry, after 6 months and after 18 months'}], 'secondaryOutcomes': [{'measure': 'Dyadic Parent-Child Interaction Coding System (DPICS)', 'timeFrame': 'Pre intervention, 6 months, 18 months', 'description': 'Parent-child interaction coded from standardized situations'}, {'measure': 'Parenting Stress Index', 'timeFrame': 'Pre intervention, 6 months, 18 months', 'description': 'Number and degree of perceived stresses by parents'}, {'measure': 'Working Model of the Child Interview (WMCI)', 'timeFrame': 'Pre intervention, 6 months, 18 months', 'description': "Parents' attachment to the child"}, {'measure': 'Child Behavior Check List (CBCL)/Teacher Report Form (TRF)', 'timeFrame': 'Pre intervention, 6 months, 18 months', 'description': 'Psychiatric symptoms as rated by parents and teachers, respectively'}, {'measure': 'Beck Depression Inventory (BDI)', 'timeFrame': 'Pre intervention, 6 months, 18 months', 'description': 'Depressive symptoms in parents'}, {'measure': 'Parental Locus of Control - Short Form (PLOC-SF)', 'timeFrame': 'Pre intervention, 6 months, 18 months', 'description': "Parents' perceptions of internal versus external locus of control"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Behavior problems', 'Parent-Child Interaction', 'Locus of control', 'Psychiatric symptoms', 'Depressive symptoms', 'Attachment'], 'conditions': ['Behavior Problems', 'Oppositional Defiant Disorder', 'Conduct Disorder']}, 'referencesModule': {'references': [{'pmid': '27622458', 'type': 'RESULT', 'citation': "Bjorseth A, Wichstrom L. Effectiveness of Parent-Child Interaction Therapy (PCIT) in the Treatment of Young Children's Behavior Problems. A Randomized Controlled Study. PLoS One. 2016 Sep 13;11(9):e0159845. doi: 10.1371/journal.pone.0159845. eCollection 2016."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to investigate whether a type of parent-based intervention, Parent-Child Interaction Therapy will lower symptoms of behavior problems in young children more than treatment as usual.', 'detailedDescription': 'Behaviour problems, i.e. symptoms of oppositional defiant disorder (ODD) and conduct disorder (CD) are among the prevalent psychiatric disorders in children and one of the leading causes of help-seeking for mental health problems in children. There are several efficacious treatments for such problems in young children. However, most of these require that parents meet in groups. This is not always feasible. It is therefore a need to develop treatments that can deal with parents and families individually. Parent-Child Interaction Therapy (PCIT) is such an individually based treatment. Efficacy studies indicate symptom reduction greater that in treatment as usual (TAU). However, there is a need to study its effectiveness in ordinary clinical practise. This trial will study its effect in ordinary psychiatric clinics in the middle of Norway and compare it to the regular treatment (TAU) provided to young children with behavior problems in these clinics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Referred to Child mental health specialty clinic for behavioral or attentional/hyperactive problems\n* ECBI score of \\> 120\n* 2 to 7 years of age\n* Parental consent to the study\n\nExclusion Criteria:\n\n* Psychosis or serious drug abuse in parents\n* Lack of sufficient proficiency in Norwegian to fill in the questionnaires\n* Mental retardation or pervasive developmental disorder in the child\n* Suspicion of parental neglect or abuse of the child warranting a report to the child protection services'}, 'identificationModule': {'nctId': 'NCT01085305', 'briefTitle': 'The Effectiveness of Parent-Child Interaction Therapy (PCIT)', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'The Effectiveness of Parent-Child Interaction Therapy (PCIT) in Treating Behavior Problems in Young Children', 'orgStudyIdInfo': {'id': '4.2006.789'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PCIT', 'description': 'Provision of Parent-Child Interaction Therapy', 'interventionNames': ['Behavioral: Parent-Child Interaction Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TAU', 'description': 'Treatment as usual from other therapists in the same clinics', 'interventionNames': ['Behavioral: TAU']}], 'interventions': [{'name': 'Parent-Child Interaction Therapy', 'type': 'BEHAVIORAL', 'description': 'Parents will be trained in interaction with their children in ways which foster non-hostility and cooperation in their children. By means of an ear-plug they will receive instruction on how to play and set limits for their child from their therapist who watches the interaction through a one-way mirror. Treatment is given until the parent masters these skill, which commonly takes 15-20 session of 1 hour.', 'armGroupLabels': ['PCIT']}, {'name': 'TAU', 'type': 'BEHAVIORAL', 'description': 'Usual treatment for behavioral disorders', 'armGroupLabels': ['TAU']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Trondheim', 'state': 'Sør-trøndelag', 'country': 'Norway', 'facility': 'barne- og ungdomspsykiatrisk klinikk, Helse Midt-Norge', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}, {'zip': '7057', 'city': 'Trondheim', 'state': 'Trondheim', 'country': 'Norway', 'facility': 'Barne- og ungdomspsykiatrisk klinikk, Sør-Trøndelag', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Lars Wichstrøm, prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Norwegian University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'St. Olavs Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}