NCT07470333

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
510

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
Last Updated

March 13, 2026

Status Verified

February 1, 2026

Enrollment Period

9 months

First QC Date

February 19, 2026

Last Update Submit

March 9, 2026

Conditions

Violence Against ChildrenParental Mental HealthParenting Practices

Outcome Measures

Primary Outcomes (4)

  • Mental Health

    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)

    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

    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

    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 Outcomes (2)

  • Overall Caregiver Health

    Baseline and 7-weeks post-baseline

  • Overall Child Health

    Baseline and 7-weeks post-baseline

Study Arms (2)

Intervention Arm

EXPERIMENTAL

The intervention arm participates in a 12-session psychosocial, mental health, and parenting support group programme called "Hope Groups".

Behavioral: Hope Groups

Control Arm

PLACEBO COMPARATOR

The control arm is a wait-list control group, who will receive the intervention after the trial concludes.

Other: Wait-list control arm

Interventions

Hope GroupsBEHAVIORAL

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

Intervention Arm
Wait-list control armOTHER

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

Control Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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'.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ukraine Without Orphans

Kyiv, Ukraine

Location

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Analysts will be blinded during randomisation and analysis.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2026

First Posted

March 13, 2026

Study Start

November 11, 2023

Primary Completion

July 30, 2024

Study Completion

February 28, 2025

Last Updated

March 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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).

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
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.
Access Criteria
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.
More information

Locations

UA(1)