Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT05770427
Status:
WITHDRAWN
Last Update Posted:
2023-05-12
First Post:
2023-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating an Online Parenting Intervention in a Community-Based Sample of Parents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Change in study design (see NCT05770414 for current and active trial).', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-10', 'studyFirstSubmitDate': '2023-02-21', 'studyFirstSubmitQcDate': '2023-03-03', 'lastUpdatePostDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Parent-child bond will be measured using the Maternal Postnatal Attachment Scale (MPAS)', 'timeFrame': 'Change from pre-intervention scores at baseline and post-intervention scores at week 8', 'description': "The MPAS is a 19-item questionnaire that assesses parents' relational attitudes towards their infant. There are three main subscales derived from the measure: Quality of Attachment, Pleasure in Interaction, and Absence of Hostility. The MPAS has shown strong psychometric properties for use in community samples and can be used with mothers and fathers."}], 'secondaryOutcomes': [{'measure': 'Parent self-efficacy will be measured using the Parent Sense of Competence Questionnaire (PSOC)', 'timeFrame': 'Change from pre-intervention scores at baseline and post-intervention scores at week 8', 'description': "The PSOC has 14-items and measures a parent's experiences in their role as a parent. There are three substances including Interest, Efficacy, and Satisfaction. The questionnaire has been widely used to assess parenting attitudes and has adequate psychometric properties."}, {'measure': 'Parental stress will be measured using the Parenting Stress Scale (PSS)', 'timeFrame': 'Change from pre-intervention scores at baseline and post-intervention scores at week 8'}, {'measure': 'Parental depression will be measured using the Centre for Epidemiological Studies Depression Scale (CES-D)', 'timeFrame': 'Change from pre-intervention scores at baseline and post-intervention scores at week 8'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parent-Child Relations']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the effectiveness of the online modality of the Make the Connection (MTC) program in a community-based sample of parents not at-risk for parenting difficulties. The main questions it aims to answer are:\n\n* Does the MTC online program result in improvements in parent-child bond, parent self-efficacy, parental stress, and parental depression among parents who are not at-risk for parent-child relationship difficulties?\n* What are some of the barriers, facilitators, perceived benefits and risks to participating in the MTC online program from the perspective of parents?\n\nParticipants will be asked to complete a pre-intervention questionnaire, will be invited to complete the 8-week MTC online program consisting of a weekly 15-minute module, and will lastly be asked to complete a post-intervention questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* parents with children between the ages of 0-3 years old\n* parents are primarily responsible for the children\n\nExclusion Criteria:\n\n* parents are at-risk for parent-child relationship difficulties (i.e., endorse two of the following criteria: being a first-time caregiver, socially isolated, low education, caregiving alone, lack of confidence or self-efficacy, at risk for poor infant sensitivity, or at-risk for depression)'}, 'identificationModule': {'nctId': 'NCT05770427', 'briefTitle': 'Evaluating an Online Parenting Intervention in a Community-Based Sample of Parents', 'organization': {'class': 'OTHER', 'fullName': 'University of Ottawa'}, 'officialTitle': 'Can We Still Make the Connection? Evaluating an Online Parenting Intervention in a Community-Based Sample of Parents of Infants and Young Children', 'orgStudyIdInfo': {'id': 'H-02-23-8888-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'interventionNames': ['Behavioral: Make the Connection® Online Program']}], 'interventions': [{'name': 'Make the Connection® Online Program', 'type': 'BEHAVIORAL', 'description': "Make the Connection® (MTC) is an evidence-based parenting program offered by Strong Minds Strong Kids, Psychology Canada. Recently, the MTC program has been adapted to an online platform to help increase scalability and accessibility across Canada. The online modality is self-administered by parents and consist of 8 weekly, 15-minute modules.\n\nMTC is an attachment-focused, evidence-informed, parent training program that is designed to support the development of positive parent-child relationships by teaching parents to understand their infant's cues. The overarching goal of the program is to enhance parental attitudes and cognitions towards their infants, which have been shown to be associated with sensitive parenting behaviour, and in turn, secure child attachment. Ultimately, by improving parenting skills and attitudes, the program seeks to support secure infant attachment.", 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1N 6N5', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Ottawa', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ottawa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}