Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-02-22 @ 2:47 PM
Study NCT ID:
NCT04346069
Status:
UNKNOWN
Last Update Posted:
2020-04-15
First Post:
2020-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role Of Parent-Child Interaction Therapy Towards Management Of Language And Behavioral Problems Among Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-14', 'studyFirstSubmitDate': '2020-03-14', 'studyFirstSubmitQcDate': '2020-04-14', 'lastUpdatePostDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'efficacy of parent chlid interaction therapy (PCIT)', 'timeFrame': '6 months', 'description': "parent child interaction therapy (PCIT)) is one of those interventions which can address these vulnerabilities by improving parent to child relation and interaction, primarily improving parenting skills and helping parents cope with their parenting stress and child's behavioral problems. efficacy will be assessed by the Parenting Stress Index - Short Form"}, {'measure': 'efficacy of parent chlid interaction therapy (PCIT) will be assessed by the Marital Status Inventory', 'timeFrame': '6 months'}, {'measure': 'efficacy of parent chlid interaction therapy (PCIT) will be assessed by the Child-Parent Relationship Scale .', 'timeFrame': '6 months'}, {'measure': 'efficacy of parent chlid interaction therapy (PCIT) will be assessed by the Eyeburg inventory.', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Disorder of Speech and Language Development']}, 'descriptionModule': {'briefSummary': "maltreatment are particularly vulnerable towards child abuse and developing mental and physical health issues.\n\nparent child interaction therapy (PCIT)) is one of those interventions which can address these vulnerabilities by improving parent to child relation and interaction, primarily improving parenting skills and helping parents cope with their parenting stress and child's behavioral problems.\n\nPCIT is empirically validated to decrease parenting stress, couple conflict and enhance parent child interaction, resulting in better coping skills while parenting for a child with disability.\n\nThis research is very vital as it measures the efficacy of parent child interaction.\n\nIn Pakistan mostly parents are bringing their children to clinic without any support from government therefore it is not possible for everyone to get daily based therapeutic intervention.\n\nThe area of Parent-child Interaction Therapy and the acceptance of these treatments are new and emerging in Pakistani Health Care, apart from above; this research will also assist in identifying further areas of research.", 'detailedDescription': 'The objective of this study is to determine the efficacy of parent-based intervention in Pakistan.\n\nParent-Child Interaction Therapy PCIT in treating the behavior problem and language problem due to behavioral disturbances in young children more than usual treatments.\n\n1. To assess efficacy of PCIT intervention program.\n2. To translate the Eyeberg Child Behavior Inventory (ECBI), Child-Parent Relationship Scale, Child Behavior Checklist (CBCL) , Test of Early Language-3rd edition (TELD-3) and applications in Urdu language.\n3. To translate Child-Parent Relationship Scale and applications in Urdu language.\n4. To translate Child Behavior Checklist (CBCL) and applications in Urdu language.\n5. To translate Test of Early Language-3rd edition (TELD-3) and applications in Urdu language.\n6. To translate parenting relation questionnaire (PQR) in Urdu language.\n7. To translate parent stress index (PSI) in Urdu.\n8. To determine the reliability and validity of the Urdu translated interventional and assessment tools.\n9. To determine prior to and at the conclusion of the intervention performance on measures of parenting relation, parenting tress, children compliance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion Criteria for children:\n\n* Participants of the study age between 2to 7years however both the genders are included\n* Referred cases for language delay, behavioral or attention/hyperactive problems\n* ECBI score of greater than 120\n* Parental consent to the study\n\nInclusion Criteria for Parents:\n\n* Biological Parents\n* Minimum education: high school\n* Willing to participate\n\nExclusion Criteria:\n\nExclusion Criteria for children:\n\n* Mental retardation or pervasive developmental disorder in the child.\n* Should not be under any other kind of the therapeutical intervention .\n\nExclusion Criteria for Parents:\n\n* Psychosis or serious drug abuse in parents\n* Lack of sufficient proficiency in parents to fill in the questionnaires'}, 'identificationModule': {'nctId': 'NCT04346069', 'briefTitle': 'Role Of Parent-Child Interaction Therapy Towards Management Of Language And Behavioral Problems Among Children', 'organization': {'class': 'OTHER', 'fullName': 'Isra University'}, 'officialTitle': 'Role Of Parent-Child Interaction Therapy Towards Management Of Language And Behavioral Problems Among Children', 'orgStudyIdInfo': {'id': 'IsraUP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Regular speech therapy', 'description': 'Regular speech therapy will be provided to the controlled group', 'interventionNames': ['Other: PCIT (parent child interaction therapy)']}, {'type': 'OTHER', 'label': 'Parent-child interaction therapy', 'description': 'Parent child interaction therapy will be provided to the experimental group', 'interventionNames': ['Other: PCIT (parent child interaction therapy)']}], 'interventions': [{'name': 'PCIT (parent child interaction therapy)', 'type': 'OTHER', 'otherNames': ['Regular speech therapy'], 'description': 'Parent child interaction therapy is a treatment strategy that nurture parent child relationship and teach effective parenting strategies to decrease child non compliance behavior (BodifordMcNeil; Hembree-Kigin, 2010).Parent-Child Interaction Therapy (PCIT; Eyberg; Robinson, 1982 ; Zisser; Eyberg, 2008 ) is a manualized parent training intervention that has received substantial empirical support in the treatment of disruptive behavior across multiple reviews (e.g., Brestan; Eyberg, 1998 ; Gallagher, 2003 ; Thomas \\& Zimmer-Gembeck, 2007 ). PCIT established strong relation among parenting, social learning, and attachment theories and proceeds.', 'armGroupLabels': ['Parent-child interaction therapy', 'Regular speech therapy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'SHAHNAZ YOUSUF, PHD', 'role': 'CONTACT', 'email': 'shahnazyousaf@gmail.com', 'phone': '03335245530'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isra University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Shahnaz', 'investigatorAffiliation': 'Isra University'}}}}