Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:31 PM
Study NCT ID:
NCT07470333
Status:
COMPLETED
Last Update Posted:
2026-03-13
First Post:
2026-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hope Groups: Parenting and Mental Health Support for Ukrainian Caregivers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Analysts will be blinded during randomisation and analysis.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 510}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-09', 'studyFirstSubmitDate': '2026-02-19', 'studyFirstSubmitQcDate': '2026-03-09', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mental Health', 'timeFrame': 'Baseline and 7-weeks post-baseline', 'description': 'Measured using PHQ-4 (the Four-Item Patient Health Questionnaire for Anxiety and Depression)'}, {'measure': 'Child Abuse (both Physical Abuse and Verbal/Emotional Abuse)', 'timeFrame': 'Baseline and 7-weeks post-baseline', 'description': 'Measured using adapted questions from ICAST-Trial (International Society for the Prevention of Child Abuse and Neglect Screening Tool for)'}, {'measure': 'Parenting Practices', 'timeFrame': 'Baseline and 7-weeks post-baseline', 'description': 'Supervision and Safety - 1.1 Measured using adapted questions from PPPS (Parent Protective Practices Scale);\n\nPositive Parenting -- 1.1. Playing with child - measured using an adapted question from APQ 1.2. Supporting child learning - measured using an adapted question from PSSS 1.3. Praising/Complimenting child -- measured using an adapted question from APQ 1.4. Calm Communication -- measured using an adapted question from PARYC'}, {'measure': 'Prevention of Violence against Women', 'timeFrame': 'Baseline and 7-weeks post-baseline', 'description': 'Measured using adapted questions from "No Means No Worldwide", in order to make questions relevant to the Ukrainian context and our specific intervention'}], 'secondaryOutcomes': [{'measure': 'Overall Caregiver Health', 'timeFrame': 'Baseline and 7-weeks post-baseline', 'description': 'Including:\n\n1. Healthy Grieving -- measured using a question created by Ukrainian mental health professionals for Ukrainian war context;\n2. Hopefulness -- measured using a question created for Ukrainian context amidst war;\n3. Self Care -- measured using a question created for Ukrainian context amidst war'}, {'measure': 'Overall Child Health', 'timeFrame': 'Baseline and 7-weeks post-baseline', 'description': "Measured via:\n\nInternalizing Behavior -- measured using an adapted question from CABI (Child and Adolescent Behavior Inventory); Externalizing Behavior -- measured using an adapted question from CABI (Child and Adolescent Behavior Inventory); Child Mood (unhappy, downhearted, tearful); Child/Parent Communication about child's problems/struggles;"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Violence Against Children', 'Parental Mental Health', 'Parenting Practices']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://osf.io/uvj67/overview', 'label': 'Open Science Framework Preregistration'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/39020408/', 'label': 'Protocol'}]}, 'descriptionModule': {'briefSummary': "Today, over 2 billion people are affected by conflict or violence, and caregivers affected by war are particularly at-risk for poor mental health and violence against children. This will be among the first RCTs evaluating a psychosocial, parenting intervention amidst a war crisis. This research is testing if 'Hope Groups' work to help families in war. Hope Groups are peer-led psychosocial and parenting support groups of 4-7 participants for Ukrainian caregivers affected by war, compared to a wait-list control group.", 'detailedDescription': "This is a carbon-copy of a preregistration published to Open Science Framework on November 9, 2023: https://osf.io/uvj67/overview.\n\nThis study is a two-armed pragmatic cluster randomized controlled trial (CRCT) to test whether 'Hope Groups' (a peer-led psychosocial and parenting support group consisting of 12 sessions) improve caregiver mental health, positive parenting, and prevention of violence against women among the intervention group post-intervention, compared to a wait-list control group. Randomization will be performed at the cluster level (the clustered unit of randomization is each Hope Group consisting of 4-7 individuals) with a 1:1 allocation ratio and pair-matched on the hope group's facilitator. All facilitators recruit 2 or 4 groups, which enables pair-matching on facilitator to account for any strong, unmeasurable confounders within a facilitator's network (see more details in 'recruitment' section). Clusters will be randomized to either receive the Hope Group program now ('intervention group') or be placed on a waitlist to receive the Hope Group after trial endline ('control group').\n\nAfter a facilitator has recruited all participants, and their participants have completed informed consent and baseline surveys, the trial data analyst will use a randomization package in RStudio to conduct the cluster pair-matched randomization (e.g., if a facilitator recruited 2 clusters, 1 group is randomized to intervention and 1 to control; if a facilitator recruited 4 groups, 2 groups are randomized to intervention and 2 to control). The trial analyst will set the seed to ensure randomization results are reproducible. The trial analyst will be blinded to the identifies of all participants within all clusters at the time of randomization. For each facilitator, their clusters will be randomized at the same time (using a randomization package in RStudio), in order to conceal allocation. After randomization is completed, the trial analyst will share the allocation of clusters with the study coordinator. The study coordinator will inform the facilitator, who will inform the intervention group(s) they will start the Hope Group intervention, and inform the control group(s) they are on a wait-list to start the Hope Group intervention after trial endline.\n\nEndline surveys will be conducted for all clusters 1-week after Hope Group completion."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant is Ukrainian (or speaks Ukrainian and has been affected by the war in Ukraine);\n* Participant is aged 18 or older\n* Participant is a parent or caregiver who spends at least 15 hours per week with at least one child\n* Participant has not already participated in a 'Hope Group'.\n\nExclusion Criteria:\n\n* NA"}, 'identificationModule': {'nctId': 'NCT07470333', 'briefTitle': 'Hope Groups: Parenting and Mental Health Support for Ukrainian Caregivers', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'Hope Groups: Psychosocial and Parenting Support Groups for Ukrainian Caregivers Affected by War', 'orgStudyIdInfo': {'id': 'R90037/RE001'}, 'secondaryIdInfos': [{'id': 'https://osf.io/uvj67/overview', 'type': 'REGISTRY', 'domain': 'Open Science Framework. This registration is a carbon copy of a preregistration submitted to OSF on November 9, 2023.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Arm', 'description': 'The intervention arm participates in a 12-session psychosocial, mental health, and parenting support group programme called "Hope Groups".', 'interventionNames': ['Behavioral: Hope Groups']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Arm', 'description': 'The control arm is a wait-list control group, who will receive the intervention after the trial concludes.', 'interventionNames': ['Other: Wait-list control arm']}], 'interventions': [{'name': 'Hope Groups', 'type': 'BEHAVIORAL', 'description': 'Hope Groups are a 12-session psychosocial, mental health, and parenting support group.', 'armGroupLabels': ['Intervention Arm']}, {'name': 'Wait-list control arm', 'type': 'OTHER', 'description': 'Wait-list control arm, with no treatment given during the RCT period.', 'armGroupLabels': ['Control Arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Ukraine Without Orphans', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}]}, 'ipdSharingStatementModule': {'url': 'https://osf.io/2tb3g/overview', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'De-identified data will be made available to researchers upon reasonable request, subject to appropriate data-use conditions. This is available beginning March 1, 2026. Fully available anonymous data will be posted on Open Science Framework after the main results and moderator results are published, likely in 2027.', 'ipdSharing': 'YES', 'description': 'IPD will be made available, including all primary and secondary outcomes and basic covariates (eg, sex, age, displacement status), but with identifiable information excluded (eg, initials, DOB, geographic location).', 'accessCriteria': 'De-identified data will be made available to researchers upon reasonable request to Sydney Tucker (sydney.tucker@spi.ox.ac.uk), subject to appropriate data-use conditions. Fully available anonymous data will be posted on Open Science Framework after the main results and moderator results are published (likely 2027), and can be directly accessed on Open Science Framework.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'collaborators': [{'name': 'World Without Orphans', 'class': 'UNKNOWN'}, {'name': 'Ukraine Without Orphans', 'class': 'UNKNOWN'}, {'name': 'Nehemiah Team Ukraine', 'class': 'UNKNOWN'}, {'name': 'There is Hope, Krakow', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}