AzTrials
AzTrials

Violence Against ChildrenNCT07470333

Hope Groups: Parenting and Mental Health Support for Ukrainian Caregivers

A study testing Hope Groups in people with Violence Against Children and Parental Mental Health, run by University of Oxford at 1 site in Ukraine.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Hope Groups
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
510 participants
Where
1 siteUkraine
Study dates
11 Nov 2023to 28 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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'.

Who cannot join

  • NA

Trial locations and contacts

1 site in 1 country.

Ukraine1 site

  • Ukraine Without Orphans

    Kyiv

Other trials in Ukraine

About this study

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

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.

Read the 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.

Being tested
Hope Groups, Wait-list control arm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hope GroupsBehavioural

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

  • Wait-list control armOther

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

Study groups in NCT07470333
Study groupRoleWhat they receive
Intervention ArmExperimentalThe intervention arm participates in a 12-session psychosocial, mental health, and parenting support group programme called "Hope Groups".
Receives: Behavioral: Hope Groups
Control ArmPlacebo comparatorThe control arm is a wait-list control group, who will receive the intervention after the trial concludes.
Receives: Other: Wait-list control arm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mental Health

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

    Measured: Baseline and 7-weeks post-baseline

  2. 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)

    Measured: Baseline and 7-weeks post-baseline

  3. 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

    Measured: Baseline and 7-weeks post-baseline

  4. 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

    Measured: Baseline and 7-weeks post-baseline

Secondary outcomes (2)

  1. 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

    Measured: Baseline and 7-weeks post-baseline

  2. 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;

    Measured: Baseline and 7-weeks post-baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2026
  2. Study start11 Nov 2023
  3. Primary completion30 Jul 2024
  4. Study completion28 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
510 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07470333
Sponsor's protocol ID
R90037/RE001
Other IDs
https://osf.io/uvj67/overview
Status last verified
Feb 2026
First submitted
19 Feb 2026
Last updated
13 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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).

Publications

  • Tucker S, Baldonado N, Ruina OH, Melendez-Torres GJ, Flaxman S, Bryn L, Rawlings L, Goldman P, Louchnikov K, Baldonado J, Machabeli T; Hope Groups Implementation Team; Vallance I, Kharchenko S, Sherr L, Ratmann O, Lachman J, Cluver L, Hillis S. Effectiveness of the hope groups intervention on mental health, parenting practices, and violence against children among Ukrainian parents and caregivers affected by war and displacement: a cluster randomised controlled trial. Lancet Reg Health Eur. 2026 Aug 25;68:101783. doi: 10.1016/j.lanepe.2026.101783. eCollection 2026 Sep.

    PubMed 42724570

Questions about this trial

What is this clinical trial studying?

A study testing Hope Groups in people with Violence Against Children and Parental Mental Health, run by University of Oxford at 1 site in Ukraine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mental Health (time frame: Baseline and 7-weeks post-baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07470333, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in