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Completed

NCT Number: NCT07470333

Hope Groups: Parenting and Mental Health Support for Ukrainian Caregivers

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.

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Key information

Conditions

Violence Against Children Parental Mental Health Parenting Practices

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ukraine Without Orphans

Kyiv, Ukraine

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hope Groups

Behavioral

Hope Groups are a 12-session psychosocial, mental health, and parenting support group.

Wait-list control arm

Other

Wait-list control arm, with no treatment given during the RCT period.

Primary outcomes

  1. Mental Health

    Time frame: Baseline and 7-weeks post-baseline

    Measured using PHQ-4 (the Four-Item Patient Health Questionnaire for Anxiety and Depression)

  2. 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)

  3. 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

  4. 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

Secondary outcomes

  1. Overall Caregiver Health

    Time frame: Baseline and 7-weeks post-baseline

    Including:

    • Healthy Grieving -- measured using a question created by Ukrainian mental health professionals for Ukrainian war context;
    • Hopefulness -- measured using a question created for Ukrainian context amidst war;
    • Self Care -- measured using a question created for Ukrainian context amidst war

  2. 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;

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • Nehemiah Team Ukraine
  • There is Hope, Krakow
  • Ukraine Without Orphans
  • World Without Orphans

Registry information

Official study title

Hope Groups: Psychosocial and Parenting Support Groups for Ukrainian Caregivers Affected by War

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Mar 13, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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