Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT04784858
Status:
UNKNOWN
Last Update Posted:
2021-09-16
First Post:
2021-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Integrating a Parenting Intervention Into Substance Use Treatment: A Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-13', 'studyFirstSubmitDate': '2021-03-02', 'studyFirstSubmitQcDate': '2021-03-04', 'lastUpdatePostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maternal Sensitivity', 'timeFrame': '9 minutes play session', 'description': 'Coded from observed parent-child interactions'}], 'secondaryOutcomes': [{'measure': 'Reflective Functioning', 'timeFrame': '5 minutes', 'description': 'Reflective Function (RF) 18-item questionnaire'}, {'measure': 'Parental Reflective Functioning', 'timeFrame': '5 minutes', 'description': 'Reflective Function Questionnaire (PRF-Q) 8-item questionnaire'}, {'measure': 'Depression, Anxiety, and Stress', 'timeFrame': '8 minutes', 'description': 'Depression, Anxiety and Stress Scale (DASS21) - 21 item questionnaire'}, {'measure': 'Parenting Stress', 'timeFrame': '10 minutes', 'description': 'Parental Stress Index (PSI) - Short Form, 36 item questionnaire'}, {'measure': 'Perceived Social Support', 'timeFrame': '5 minutes', 'description': 'Multidimensional Scale of Perceived Social Support (MSPS), 12 item questionnaire'}, {'measure': 'Difficulties in Emotion Regulation', 'timeFrame': '5 minutes', 'description': 'Difficulties in Emotion Regulation Scale-SF (DERS-SF), 18-item questionnaire'}, {'measure': 'Substance use screener', 'timeFrame': '2 minutes', 'description': 'Global Appraisal of Individual Needs (Substance Use) (GAIN), 5-item questionnaire'}, {'measure': 'Interpersonal Emotion Regulation', 'timeFrame': '8 minutes', 'description': 'Interpersonal Emotion Regulation Questionnaire (IERQ), 20-item'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parenting']}, 'descriptionModule': {'briefSummary': 'While motherhood is central to the design of maternal integrated substance use treatment programs, "evidence-based" parenting interventions tailored to the needs of the population are rare. Stakeholder engagement has revealed that the evidence-base is not reflective of the needs of client population. With 34 ECD programs in Ontario, ECD programs are unique position to pilot Attachment and Biobehavioral Catch Up (ABC) and see if it is a good fit for their clients and if it is effective and feasible. ABC is 10-week evidence-based parenting intervention for parents who live in the context of complex risk, including mental health, addictions, child welfare involvement, and poverty. Investigators of this project will complete a open label mixed method feasibility pilot study involving active implementation of ABC that will involve: 1. exploration facilitators and barriers of the year-long implementation and training process and 2. exploration of changes in maternal mental health, substance use and parenting outcomes from beginning to end of treatment. Results of this mixed method pilot study will inform a larger trial with a control group and support a funding application to support its completion.', 'detailedDescription': 'While motherhood is central to the design of maternal integrated substance use treatment programs, there are few "evidence-based" parenting interventions tailored to the needs of the population. This study will address this limitation in current parenting intervention research by exploring if Attachment and Biobehavioral Catch Up (ABC) is well suited and feasible to implement within integrated maternal substance use outpatient treatment. ABC is 10-week evidence-based parenting intervention for parents who live in the context of complex risk, including mental health, addictions, child welfare involvement, and poverty. Investigators of this project will complete a open label mixed method feasibility pilot study involving active implementation of ABC that will involve: 1. exploration facilitators and barriers of the year-long implementation and training process and 2. exploration of changes in maternal mental health, substance use and parenting outcomes from beginning to end of treatment. Results of this mixed method pilot study will inform a larger trial with a control group and support a funding application to support its completion.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Mothers who experience vulnerability and are challenged by substance use disorder trauma, and/or poverty.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women pregnant/parenting children ages 6-24 months\n* Women that are clients of participating ECD agencies\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04784858', 'briefTitle': 'Integrating a Parenting Intervention Into Substance Use Treatment: A Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'Toronto Metropolitan University'}, 'officialTitle': 'Integrating a Parenting Intervention Into Substance Use Treatment: A Feasibility Study', 'orgStudyIdInfo': {'id': 'ABCforECD'}}, 'contactsLocationsModule': {'locations': [{'zip': 'M5B2K3', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Erica Rodrigues', 'role': 'CONTACT', 'email': 'mothers@ryerson.ca', 'phone': '4169795000', 'phoneExt': '553325'}, {'name': 'Laura Herman', 'role': 'CONTACT', 'email': 'cfwise@ryerson.ca', 'phone': '4167951255', 'phoneExt': '553325'}], 'facility': 'Ryerson University', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Karen Milligan, PhD', 'role': 'CONTACT', 'email': 'cfwise@ryerson.ca', 'phone': '4169795000', 'phoneExt': '557054'}, {'name': 'Erica Rodrigues', 'role': 'CONTACT', 'email': 'mothers@ryerson.ca', 'phone': '4169795000', 'phoneExt': '553235'}], 'overallOfficials': [{'name': 'Karen Milligan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Toronto Metropolitan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Toronto Metropolitan University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Niagara Health System', 'class': 'OTHER'}, {'name': 'house of sophrosyne', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Karen Milligan', 'investigatorAffiliation': 'Toronto Metropolitan University'}}}}