Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2026-03-13 @ 1:57 PM
Study NCT ID:
NCT04077112
Status:
COMPLETED
Last Update Posted:
2021-09-20
First Post:
2019-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Intensive Parent-Child Interaction Therapy"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-13', 'studyFirstSubmitDate': '2019-08-30', 'studyFirstSubmitQcDate': '2019-08-30', 'lastUpdatePostDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Externalizing Behavior Problems', 'timeFrame': 'The measure was collected prior to the start of treatment, immediately following treatment, as well as 6-9 months upon treatment completion', 'description': "Mothers completed the Eyberg Child Behavior Inventory (ECBI; Eyberg \\& Ross, 1978), a 36-item questionnaire that is designed to assess the presence of externalizing problems in children ages 2 through 16 years. The total intensity scale t-score was used in the current study as the main measure of EBP (α's .84-.93).\n\nThe total raw score ranged from 36 to 252. Higher scores indicate the presence of more externalizing behavior problems."}], 'secondaryOutcomes': [{'measure': 'Change in Parenting Skills', 'timeFrame': 'The measure was collected prior to the start of treatment, immediately following treatment, as well as 6-9 months upon treatment completion', 'description': "The Dyadic Parent-Child Interaction Coding System-4th Edition (DPICS-IV; Eyberg, Nelson, Ginn, Bhuiyan, \\& Boggs, 2013), an established behavioral coding system was used to measure the quality of parent-child interactions across all assessments. Consistent with prior PCIT research, we created a composite of do skills (behavior descriptions, reflections, praises) and don't skills (questions, commands, and negative talk) reflecting behaviors parents are taught during treatment to use and not use during a child-led play. Undergraduate student coders, who were masked to treatment status, were trained to 80% agreement with a criterion tape and coded 20% of the observations a second time to assess reliability. Reliability for the do (r's range from .87 to .94) and don't skills were excellent (r's .99)."}, {'measure': 'Change in Parenting stress', 'timeFrame': 'The measure was collected prior to the start of treatment, immediately following treatment, as well as 6-9 months upon treatment completion', 'description': "Mothers completed the Parenting Stress Index-Short Form (PSI-SF; Abidin, 1983). The PSI-SF is a widely used 36-item self-report instrument for parents of children ages 1 month to 12 years measuring parental stress (Abidin, 1983). The PSI-SF total raw score was used to measure overall parenting stress (α's .88-.94). Total score range from 36 to 180 with higher scores indicating greater levels of parenting stress."}, {'measure': 'Change in Discipline Practices', 'timeFrame': 'The measure was collected prior to the start of treatment, immediately following treatment, as well as 6-9 months upon treatment completion', 'description': "Mothers completed the Parenting Scale (PS; Arnold, O'Leary, Wolff, \\& Acker, 1993), a 30-item self-report measure that assesses parental discipline practices of children as young as 18 months. The effectiveness of discipline techniques is measured based on three factor scores (Laxness, Over-Reactivity, Verbosity). The Laxness (α's = .82-.88) and Over-Reactivity (α's = .67-.83) scales were used to assess parenting practices. Due to poor reliability of the Verbosity scale (.33-.70), this scale was removed from all analyses."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Behavior Problem', 'Parenting']}, 'descriptionModule': {'briefSummary': 'The purpose to the current study was to examine the comparative efficacy of a more condensed intensive version of Parent-Child Interaction Therapy (I-PCIT; 5 days/week over the course of 2 weeks) versus a more traditional weekly PCIT format (1 day/week over the course of 10 weeks) in treating early childhood externalizing behavior problems (EBP).', 'detailedDescription': 'The purpose to the current study was to examine the comparative efficacy of a more condensed intensive version of Parent-Child Interaction Therapy (I-PCIT; 5 days/week over the course of 2 weeks) versus a more traditional weekly PCIT format (1 day/week over the course of 10 weeks) in treating early childhood externalizing behavior problems (EBP). Using a randomized trial design, 60 young children (M child age = 4.33 years; range 2-6.92; 65% male; 85% Latinx) with elevated levels of EBP and their mothers were assigned to either I-PCIT (n = 30) or traditional PCIT (n = 30). Families completed pre-treatment and post-treatment assessments as well as a follow-up assessment 6-9 months following treatment completion. Across all assessments, mothers completed measures of child behavior, discipline practices, and parenting stress. Observational data on child behavior and parenting was also collected during three 5-minute standard situations that vary in the degree of parental control (child-led play, parent-led play, \\& clean-up).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children had to be between 2 and 7 years of age\n* mothers had to rate their children above the clinically significant range (T-score \\> 60) on a measure of child EBP (Eyberg Child Behavior Inventory; Eyberg \\& Pincus, 1999),\n* be willing to come to treatment every day (Monday - Friday) during a two-week period,\n* both mother and child had to be able to speak and understand English.\n\nExclusion Criteria:\n\n* An intellectual disability (full scale IQ \\< 70 based on the WPPSI-IV; Wechsler, 2012),\n* A previous Autism Spectrum Disorder diagnosis,\n* The inability of parents to attend sessions daily.'}, 'identificationModule': {'nctId': 'NCT04077112', 'acronym': 'IPCIT', 'briefTitle': 'Evaluation of Intensive Parent-Child Interaction Therapy"', 'organization': {'class': 'OTHER', 'fullName': 'Florida International University'}, 'officialTitle': 'Evaluation of Intensive Parent-Child Interaction Therapy"', 'orgStudyIdInfo': {'id': 'IRB-16-0323-CR03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'traditional PCIT', 'description': 'once a week parent training', 'interventionNames': ['Behavioral: Parent Child Interaction Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'intensive PCIT', 'description': 'every day for two weeks parent training', 'interventionNames': ['Behavioral: Parent Child Interaction Therapy']}], 'interventions': [{'name': 'Parent Child Interaction Therapy', 'type': 'BEHAVIORAL', 'description': 'Behavioral parent training program targeting parent-child relationship', 'armGroupLabels': ['intensive PCIT', 'traditional PCIT']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'final data set will be available upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Florida International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}