- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07470333
Hope Groups: Parenting and Mental Health Support for Ukrainian Caregivers
Hope Groups: Psychosocial and Parenting Support Groups for Ukrainian Caregivers Affected by War
Study Overview
Status
Intervention / Treatment
Detailed Description
This is a carbon-copy of a preregistration published to Open Science Framework on November 9, 2023: https://osf.io/uvj67/overview.
This 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').
After 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.
Endline surveys will be conducted for all clusters 1-week after Hope Group completion.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kyiv, Ukraine
- Ukraine Without Orphans
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participant is Ukrainian (or speaks Ukrainian and has been affected by the war in Ukraine);
- Participant is aged 18 or older
- Participant is a parent or caregiver who spends at least 15 hours per week with at least one child
- Participant has not already participated in a 'Hope Group'.
Exclusion Criteria:
- NA
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Arm
The intervention arm participates in a 12-session psychosocial, mental health, and parenting support group programme called "Hope Groups".
|
Hope Groups are a 12-session psychosocial, mental health, and parenting support group.
|
|
Placebo Comparator: Control Arm
The control arm is a wait-list control group, who will receive the intervention after the trial concludes.
|
Wait-list control arm, with no treatment given during the RCT period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mental Health
Time Frame: Baseline and 7-weeks post-baseline
|
Measured using PHQ-4 (the Four-Item Patient Health Questionnaire for Anxiety and Depression)
|
Baseline and 7-weeks post-baseline
|
|
Child Abuse (both Physical Abuse and Verbal/Emotional Abuse)
Time Frame: Baseline and 7-weeks post-baseline
|
Measured using adapted questions from ICAST-Trial (International Society for the Prevention of Child Abuse and Neglect Screening Tool for)
|
Baseline and 7-weeks post-baseline
|
|
Parenting Practices
Time Frame: Baseline and 7-weeks post-baseline
|
Supervision and Safety - 1.1 Measured using adapted questions from PPPS (Parent Protective Practices Scale); Positive 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 |
Baseline and 7-weeks post-baseline
|
|
Prevention of Violence against Women
Time Frame: Baseline and 7-weeks post-baseline
|
Measured using adapted questions from "No Means No Worldwide", in order to make questions relevant to the Ukrainian context and our specific intervention
|
Baseline and 7-weeks post-baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Caregiver Health
Time Frame: Baseline and 7-weeks post-baseline
|
Including:
|
Baseline and 7-weeks post-baseline
|
|
Overall Child Health
Time Frame: Baseline and 7-weeks post-baseline
|
Measured via: Internalizing 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; |
Baseline and 7-weeks post-baseline
|
Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R90037/RE001
- https://osf.io/uvj67/overview (Registry Identifier: Open Science Framework. This registration is a carbon copy of a preregistration submitted to OSF on November 9, 2023.)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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