Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-30 @ 12:22 AM
Study NCT ID:
NCT07418320
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-18
First Post:
2026-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Grow Together, Thrive Together: A Feasibility Study of a Brief Relationship Intervention for Emerging Adults and Their Caregivers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-10', 'studyFirstSubmitDate': '2026-02-10', 'studyFirstSubmitQcDate': '2026-02-10', 'lastUpdatePostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment Feasibility', 'timeFrame': 'Week 0-58', 'description': 'Recruitment feasibility will be assessed by the proportion of the target sample of emerging adult-caregiver dyads successfully recruited during the planned recruitment period (58 weeks from March 20 2026 to May 1 2027). Feasibility will be evaluated against a predefined success criterion of recruiting at least 70% of the target sample.'}, {'measure': 'Caregiver Socioeconomic Status (Income and Education)', 'timeFrame': 'Week 0', 'description': 'Percentage of caregivers meeting socioeconomic criteria, defined as having a household income below the Toronto median and/or a high school education or less. Feasibility will be evaluated against a predefined benchmark of ≥30% of caregivers meeting these criteria.'}, {'measure': 'Participant Retention', 'timeFrame': 'Week 0-10', 'description': 'Participant retention will be assessed as the proportion of enrolled emerging adult-caregiver dyads who complete the post-intervention assessment one week after the final writing session. Feasibility will be evaluated against a predefined success criterion of at least 75% dyad retention.'}, {'measure': 'Intervention Adherence', 'timeFrame': 'Week 1-9', 'description': 'Intervention adherence will be assessed as the proportion of emerging adult-caregiver dyads who complete at least two of the three online writing sessions. Feasibility will be evaluated against a predefined success criterion of at least 75% adherence.'}, {'measure': 'Intervention Uptake', 'timeFrame': 'Week 5-10', 'description': 'Intervention uptake will be assessed as the proportion of emerging adult-caregiver dyads reporting use of the conflict reappraisal strategy since their previous intervention session. Feasibility will be evaluated against a predefined success criterion of at least 80% uptake.'}, {'measure': 'Intervention Acceptability', 'timeFrame': 'Week 10', 'description': 'Intervention acceptability will be assessed using participant responses to a validated acceptability questionnaire based on the Theoretical Framework of Acceptability. Acceptability will be evaluated as the proportion of participants endorsing at least "agree" on 80% or more of questionnaire items, with a predefined success criterion of at least 80%.'}, {'measure': 'Digital Usability', 'timeFrame': 'Week 10', 'description': 'Digital usability will be assessed using participant ratings on the Ease of Use and Comprehension subscales of the Website Evaluation Questionnaire. Usability will be evaluated as the proportion of participants endorsing at least "agree" on 80% or more of items, with a predefined success criterion of at least 80%.'}, {'measure': 'Racial Diversity', 'timeFrame': 'Week 0', 'description': 'Percentage of participants identifying as racialized. Feasibility will be evaluated against a predefined benchmark of ≥55.7% racialized participants.'}, {'measure': 'Sexual and Gender Diversity', 'timeFrame': 'Week 0', 'description': 'Percentage of emerging adult participants identifying as Two-Spirit, lesbian, gay, bisexual, transgender, queer, or other sexual and/or gender minority identities (2SLGBTQ+). Feasibility will be evaluated against a predefined benchmark of ≥10.5% 2SLGBTQ+ emerging adults.'}, {'measure': 'Immigrant Status', 'timeFrame': 'Week 0', 'description': 'Percentage of participants who are foreign-born. Feasibility will be evaluated against a predefined benchmark of ≥46.6% foreign-born participants.'}], 'secondaryOutcomes': [{'measure': 'Change in Emerging Adult-Caregiver Relationship Quality', 'timeFrame': 'Pre-post change from Week 0 to Week 10', 'description': 'Relationship quality will be assessed using the Parental Environment Questionnaire (PEQ; caregiver and emerging adult versions), which includes five subscales: conflict, involvement, regard for parent, regard for child, and structure. Exploratory analyses will examine mean change from baseline to one week post-intervention.'}, {'measure': 'Change in Conflict Behavior', 'timeFrame': 'Pre-post change from Week 0 to Week 10', 'description': 'Conflict behavior will be assessed using the 20-item Conflict Behavior Questionnaire (CBQ-20; caregiver and emerging adult versions). Exploratory analyses will examine pre-post changes in reported conflict behaviors from baseline to one week post-intervention.'}, {'measure': 'Change in Emerging Adult Support-Seeking and Perceived Support', 'timeFrame': 'Pre-post change from Week 0 to Week 10', 'description': 'Emerging adult support-seeking behaviors and perceptions of support received from caregivers will be assessed using two five-item self-report scales completed by emerging adults. The scales assess the frequency and perceived quality of support-seeking behaviors and caregiver support responses. Exploratory analyses will examine pre-post change from baseline to one week post-intervention.'}, {'measure': 'Change in Conflict-Related Distress', 'timeFrame': 'Pre-post change from Week 0 to Week 10', 'description': 'Conflict-related distress will be assessed using two self-report items following each fact-based conflict summary assessing distress related to caregiver or emerging adult behavior during conflicts. Exploratory analyses will examine change from baseline to one week post-intervention.'}, {'measure': 'Change in Parental Autonomy Support', 'timeFrame': 'Pre-post change from Week 0 to Week 10', 'description': 'Parental autonomy-support will be assessed using caregiver- and emerging adult-report measures assessing autonomy-supportive parenting behaviors. Exploratory analyses will examine pre-post change in parental autonomy-support from baseline to one week post-intervention.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Parent-Child Relations', 'Interpersonal Relations', 'Family Relations', 'Primary Prevention', 'Health Promotion', 'Emerging Adulthood'], 'conditions': ['Parent Child Relationship', 'Interpersonal Relations', 'Young Adults']}, 'descriptionModule': {'briefSummary': "Background. Emerging adulthood is a period of major change in young people's lives, including increased independence, new responsibilities, and shifting relationships with parents or caregivers. During this time, disagreements between emerging adults and caregivers are common and may become more frequent or emotionally intense. How families manage these disagreements may affect relationship quality and emotional well-being for both emerging adults and caregivers. However, there are few brief, accessible programs designed to support emerging adults and caregivers together during this transition.\n\nGrow Together, Thrive Together (G2T2) is a brief, online, writing-based relationship program designed for emerging adults and their caregivers. The program encourages participants to reflect on disagreements using a neutral, outside-observer perspective, with the goal of helping families approach conflict in healthier ways. G2T2 is designed to be low-intensity, self-directed, and accessible, and can be completed remotely using secure online platforms.\n\nThe purpose of this study is to evaluate the feasibility and acceptability of the G2T2 program and study procedures, rather than to test effectiveness. This feasibility clinical trial will examine whether emerging adult-caregiver dyads can be successfully recruited and retained, whether participants complete the writing sessions as planned, and whether participants find the program acceptable, easy to use, and understandable. The study will also explore whether participants report using the conflict reappraisal strategy outside of the writing sessions and examine changes in relationship and conflict-related outcomes before and after the program to inform future research.\n\nParticipants will take part as emerging adult-caregiver pairs. Each participant will complete an online baseline survey, three brief online writing sessions completed over approximately nine weeks, and a follow-up survey one week after the final session. Each writing session includes brief questions about recent disagreements, a short instructional video, brief questions to check understanding of the strategy, and guided writing exercises focused on reflecting on disagreements and planning how to use the strategy in future interactions. All activities are completed independently and online. Findings from this study will be used to refine the G2T2 program and study procedures and to inform the design of a future, larger randomized controlled trial."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Emerging adults aged 18-25 years and their primary caregiver or parent, enrolled as emerging adult-caregiver dyads\n* Both members of the dyad must independently provide informed consent prior to participation\n* Sufficient English literacy to complete online questionnaires in English\n* Reliable access to the internet via a computer or mobile device\n* Dyad members may live together or separately\n* Participants may continue usual or recommended mental health care (e.g., psychotherapy, pharmacotherapy) during the study\n\nExclusion Criteria:\n\n* Concurrent participation in a structured family-based intervention (e.g., manualized family therapy or family skills programs) during the study period'}, 'identificationModule': {'nctId': 'NCT07418320', 'acronym': 'G2T2', 'briefTitle': 'Grow Together, Thrive Together: A Feasibility Study of a Brief Relationship Intervention for Emerging Adults and Their Caregivers', 'organization': {'class': 'OTHER', 'fullName': 'York University'}, 'officialTitle': 'Grow Together, Thrive Together (G2T2): A Feasibility Study of a Brief Writing-Based Relationship Intervention for Emerging Adults and Their Caregivers', 'orgStudyIdInfo': {'id': '4466'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Grow Together, Thrive Together (G2T2) Intervention', 'description': 'The Grow Together, Thrive Together (G2T2) intervention is a brief, online, self-directed, writing-based relationship intervention for emerging adult-caregiver dyads. Each member of the dyad independently completes three guided writing sessions over approximately nine weeks. Sessions include brief questionnaires assessing recent conflict frequency and distress, a short instructional video introducing a neutral, third-party perspective on conflict, and a brief set of multiple-choice learning check questions to assess understanding of the conflict reappraisal strategy. Participants then complete structured writing prompts that encourage conflict reappraisal, reflection on barriers to strategy use, and planning for applying the strategy in future interactions. Participants also receive brief email or SMS reminders between sessions to encourage practice of the strategy. All study procedures are delivered remotely via secure online platforms.', 'interventionNames': ['Behavioral: Grow Together Thrive Together (G2T2)']}], 'interventions': [{'name': 'Grow Together Thrive Together (G2T2)', 'type': 'BEHAVIORAL', 'description': 'Grow Together, Thrive Together (G2T2) is a brief, online, writing-based relationship intervention designed for emerging adult-caregiver dyads. The intervention is grounded in conflict reappraisal and third-party perspective-taking and aims to reduce negative reciprocity during disagreements by helping participants reinterpret conflicts from a neutral, outside-observer perspective. Across sessions, participants are guided through structured writing exercises that focus on describing recent disagreements factually, considering alternative interpretations of the conflict, identifying barriers to applying the strategy, and planning how to use the reappraisal approach in future interactions. Instructional video content and brief learning check questions support understanding of the core strategy. The intervention is designed to be low-intensity, scalable, and culturally responsive, and is adapted from an evidence-informed writing intervention previously tested in other relational contexts.', 'armGroupLabels': ['Grow Together, Thrive Together (G2T2) Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M3J 1P3', 'city': 'North York', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Heather Prime, PhD', 'role': 'CONTACT', 'email': 'hprime@yorku.ca', 'phone': '416-736-5117'}, {'name': 'Parker Grant, HBSc', 'role': 'CONTACT', 'email': 'parkerg@yorku.ca', 'phone': '780-983-9996'}, {'name': 'Heather Prime, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'York University'}], 'centralContacts': [{'name': 'Heather Prime, PhD', 'role': 'CONTACT', 'email': 'hprime@yorku.ca', 'phone': '416-736-5117'}, {'name': 'Parker Grant, HBSc', 'role': 'CONTACT', 'email': 'parkerg@yorku.ca', 'phone': '780-983-9996'}], 'overallOfficials': [{'name': 'Heather Prime, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'York University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'York University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Toronto', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor in the Department of Psychology, York University', 'investigatorFullName': 'Heather Prime', 'investigatorAffiliation': 'York University'}}}}