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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
510
Hope Groups are a 12-session psychosocial, mental health, and parenting support group.
Wait-list control arm, with no treatment given during the RCT period.
Ukraine Without Orphans
Kyiv, Ukraine
Mental Health
Measured using PHQ-4 (the Four-Item Patient Health Questionnaire for Anxiety and Depression)
Time frame: Baseline and 7-weeks post-baseline
Child Abuse (both Physical Abuse and Verbal/Emotional Abuse)
Measured using adapted questions from ICAST-Trial (International Society for the Prevention of Child Abuse and Neglect Screening Tool for)
Time frame: Baseline and 7-weeks post-baseline
Parenting Practices
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
Time frame: Baseline and 7-weeks post-baseline
Prevention of Violence against Women
Measured using adapted questions from "No Means No Worldwide", in order to make questions relevant to the Ukrainian context and our specific intervention
Time frame: Baseline and 7-weeks post-baseline
Overall Caregiver Health
Including: 1. Healthy Grieving -- measured using a question created by Ukrainian mental health professionals for Ukrainian war context; 2. Hopefulness -- measured using a question created for Ukrainian context amidst war; 3. Self Care -- measured using a question created for Ukrainian context amidst war
Time frame: Baseline and 7-weeks post-baseline
Overall Child Health
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;
Time frame: Baseline and 7-weeks post-baseline
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