Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT06828302
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-08
First Post:
2025-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Internet-delivered Parent-Child Interaction for Parents of Children 2-7 Years With Disruptive Behaviors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000066553', 'term': 'Problem Behavior'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D002652', 'term': 'Child Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Self-reported outcomes assessed online without any influence from study staff.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Uncontrolled feasibility study using pretest-posttest design with 2 mo FU as primary endpoint.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2025-02-10', 'studyFirstSubmitQcDate': '2025-02-10', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Working Alliance Inventory', 'timeFrame': 'Treatment week 3', 'description': 'Questionnaire measuring alliance with therapist. 6 items scored on a scale from 1 (never) to 7 (always). Minimum value: 6. Maximum value: 42. A higher score means better outcome.'}, {'measure': 'Credibility Rating Scale', 'timeFrame': 'Treatment week 3', 'description': 'Questionnaire measuring treatment credibility. 5 items scored on a scale from 0 (not at all) to 10 (very). Minimum value: 0. Maximum value: 50. A higher score means better outcome.'}, {'measure': 'The Client Satisfaction Questionnaire', 'timeFrame': 'Posstreatment (treatment week 10)', 'description': 'Questionnaire measuring satisfaction with treatment. 8 items with answers ranging from 1 (bad) to 4 (very good). Minimum value: 8. Maximum value: 32. A higher score means better outcome.'}, {'measure': 'Subjective Adequate Relief Questionnaire', 'timeFrame': 'Posstreatment (treatment week 10)', 'description': 'Questionnaire that measures self-perceived change in symptoms as a result of the treatment. The scale consists of 1 item rated from 0 (much worse) to 6 (much better).'}, {'measure': 'Adverse events questionnaire', 'timeFrame': 'Posstreatment (treatment week 10)', 'description': 'Short 6-item questionnaire to identify if any adverse events have occurred due to treatment'}], 'primaryOutcomes': [{'measure': 'Eyberg Child Behavior Inventory', 'timeFrame': 'From pretreatment to 18 weeks', 'description': 'Caregiver report form measuring disruptive behaviors in children. 36 items with answers ranging from 1 (never) to 7 (always). Minimum value: 36. Maximum value: 252. A higher score means worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Weekly assessment of Child Behavior Forms', 'timeFrame': 'From pretreatment to 18 weeks', 'description': 'Short caregiver report form measuring disruptive behaviors in children. Two scales with 9 items each with answers ranging from 1 (never) to 7 (always). Minimum value: 9. Maximum value: 63. A higher score means worse outcome.'}, {'measure': 'Child Behavior Checklist', 'timeFrame': 'From pretreatment to 10 weeks', 'description': 'Caregiver report form identifying problem behavior in children. 99 items with answers ranging from 0 (do not agree) to 2 (strongly agree). Minimum value: 0. Maximum value: 198. A higher score means worse outcome.'}, {'measure': 'Dyadic Parent-Child Interaction Coding System', 'timeFrame': 'From pretreatment to 10 weeks', 'description': 'Observation System measuring parental behavior and child behavior. The frequency of specified behaviors are measured during a five minute long standardized play situation.'}, {'measure': 'Brunnsviken Brief Quality of Life Scale', 'timeFrame': 'From pretreatment to 18 weeks', 'description': 'Questionnaire about quality of life. 12 items with answers ranging from 1 (strongly disagree) to 4 (strongly agree). Minimum value: 0. Maximum value: 96. A higher score means better outcome.'}, {'measure': 'Perceived Stress Scale', 'timeFrame': 'From pretreatment to 18 weeks', 'description': 'Questionnaire measuring overall stress. A 7-item version of the scale will be used with answers ranging from 0 (never) to 4 (very often). Minimum value: 0. Maximum value: 28. A higher score means worse outcome.'}, {'measure': 'Parental Stress Scale', 'timeFrame': 'From pretreatment to 18 weeks', 'description': 'Questionnaire measuring stress induced by parenthood. 18 items with answers from 1 ("strongly disagree") to 5 ("strongly agree"). Minimum value: 18. Maximum value: 90. A higher score means worse outcome.'}, {'measure': 'Difficulties in Emotion Regulation Scale', 'timeFrame': 'From pretreatment to 18 weeks', 'description': 'Questionnaire measuring emotion regulation ability. 16 items with answers ranging from 1 (almost never) to 5 (almost always). Minimum value: 16. Maximum value: 80. A higher score means worse outcome.'}, {'measure': 'Parenting Young Children Scale', 'timeFrame': 'From pretreatment to 18 weeks', 'description': 'Questionnaire measuring parental strategies. 6 items with answers ranging from 1 (never) to 7 (many times a day). Minimum value: 6. Maximum value: 42. A higher score means better outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Internet-CBT', 'Parent', 'Children', 'Parent-Child Interaction Therapy'], 'conditions': ['Disruptive Behavior']}, 'descriptionModule': {'briefSummary': 'The goal of this feasibility study is to evaluate feasibility of Internet-delivered Parent-Child Interaction Therapy for parents of children 2-7 years with disruptive behaviors. The main questions it aims to answer are:\n\n1. Could a brief online version of PCIT (iPCIT) be feasible for reducing disruptive behaviors and internalizing problems in young children, and for improving the quality of parent-child interaction?\n2. How is iPCIT experienced by participating parents?\n\nParticipants will receive a 10-week online intervention of Parent-Child Interaction Therapy and answer questionnaires online weekly.', 'detailedDescription': 'Severe early behavioral problems increase the risk of impaired functioning in childhood and later life. Parent-Child Interaction Therapy (PCIT) is particularly effective for young children (age 2-7) with disruptive behaviors but is unimplemented in Sweden. Barriers to PCIT implementation include time constraints for parents and therapist challenges. An abbreviated internet-delivered version, iPCIT, may address these barriers. The objective of the study is to evaluate feasibility and acceptability of iPCIT.\n\nResearch questions\n\nThis study will use an uncontrolled pretest-posttest design, all participants will receive the intervention. The intervention consists of 10 weekly modules delivered over the Internet with guided support from an experienced CBT-trained psychologist and 5 biweekly videosessions where parents practice parental skills in a play situation with their child while receiving feedback and support from their therapist.\n\nAssessments will be made pretreatment, weekly during treatment for the primary outcome and potential mediators, posttreatment, at the primary endpoint 2 months after treatment completion and at follow up 6 months after treatment completion. Twenty participants (parents of children aged 2-7 years) will be included. All outcome data will be collected digitally and include for feasibility: treatment credibility, working alliance, compliance with the treatment (number of modules completed), any adverse events, subjective overall relief and satisfaction with treatment. For potential efficacy, the clinical effect in the group will be analyzed on pre- to post-measurements, including weekly measurements and 2 months follow up after treatment termination (primary endpoint). The participants will be followed 6 months after treatment completion to analyze long term clinical effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 2-7 years\n* Disruptive behaviors as assessed with Eyberg Child Behavior Inventory (ECBI) ≥126 for boys and ≥121 for girls (which corresponds to the 90th percentile according to Swedish norms)\n* Language ability equivalent to at least an average 2-year-old, defined as a vocabulary of ≥ 25 word and ability to understand simple instructions, assessed with a language screening form\n\nExclusion Criteria:\n\n* Severe autism spectrum condition (autism level 2 or 3 or equivalent functioning)\n* parents who are not proficient enough in the Swedish language to complete questionnaries and receive therapy without an interpreter\n* Presence of severe parental psychiatric disorders such as psychosis or suicidal ideations\n* Ongoing severe psychosocial distress such as custody dispute.'}, 'identificationModule': {'nctId': 'NCT06828302', 'acronym': 'iPCIT pilot', 'briefTitle': 'Internet-delivered Parent-Child Interaction for Parents of Children 2-7 Years With Disruptive Behaviors', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Internet-delivered Parent-Child Interaction for Parents of Children 2-7 Years With Disruptive Behaviors', 'orgStudyIdInfo': {'id': 'EPM Dnr: 2024-06544-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'iPCIT', 'description': 'Online parent management training (PMT) to teach parental skills (10 weekly online modules) combined with videosession for coaching of parental skills (5 biweekly sessions)', 'interventionNames': ['Behavioral: Internet-delivered Parent-Child Interaction Therapy']}], 'interventions': [{'name': 'Internet-delivered Parent-Child Interaction Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['Internet-CBT', 'Internet-delivered cognitive behavior therapy'], 'description': 'Parent management training delivered online where Internet-modules are combined with video sessions for live coaching.', 'armGroupLabels': ['iPCIT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Centre for Psychiatry Research, Karolinska Institutet', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Marianne Bonnert, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Psychiatry Research, Karolinska Institutet & Stockholm Health Care Stockholm Sweden'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, lic psych, principal investigator', 'investigatorFullName': 'Marianne Bonnert', 'investigatorAffiliation': 'Karolinska Institutet'}}}}