Hope Groups: Psychosocial and Parenting Support Groups for Ukrainian Caregivers Affected by War
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 510
- 试验地点
- 1
- 主要终点
- Mental Health
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Analysts will be blinded during randomisation and analysis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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'.
排除标准
- 未提供
研究组 & 干预措施
Intervention Arm
The intervention arm participates in a 12-session psychosocial, mental health, and parenting support group programme called "Hope Groups".
干预措施: Hope Groups (Behavioral)
Control Arm
The control arm is a wait-list control group, who will receive the intervention after the trial concludes.
干预措施: Wait-list control arm (Other)
结局指标
主要结局
Mental Health
时间窗: Baseline and 7-weeks post-baseline
Measured using PHQ-4 (the Four-Item Patient Health Questionnaire for Anxiety and Depression)
Child Abuse (both Physical Abuse and Verbal/Emotional Abuse)
时间窗: 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)
Parenting Practices
时间窗: 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
Prevention of Violence against Women
时间窗: 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
次要结局
- Overall Caregiver Health(Baseline and 7-weeks post-baseline)
- Overall Child Health(Baseline and 7-weeks post-baseline)