Evaluation of the Teaching Recovery Techniques plus Parenting, a Cluster Randomised Controlled Trial in Ukrainian Schools in Ternopil (TRUST)
| ISRCTN | ISRCTN15476405 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15476405 |
- Submission date
- 13/03/2023
- Registration date
- 28/04/2023
- Last edited
- 26/03/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Children exposed to war-related trauma are at significant risk of developing mental health problems, such as symptoms of post-traumatic stress disorder (PTSD). The aim of this study is to evaluate a community-based intervention called ‘Teaching Recovery Techniques Plus Parenting’ (TRT+P) for Ukrainian children experiencing PTSD symptoms.
Who can participate?
All schools in Ternopil will be invited to take part in the study. All parents will receive information about the study with an opt-out consent option prior to the screening with CRIES-8. Children are eligible to participate if all of the following criteria are satisfied at the time of randomisation:
1. The child is aged 8 to 13 years old
2. The child screens positive on the Children’s Revised Impact of Event Scale (CRIES-8) PTSD screening tool (≥17 points)
3. The child is interested in participating in a group intervention
4. The legal guardian does not object to participation and a parent or other primary caregiver wishes to participate
5. The participating caregiver has not taken part in another parenting programme in the past 12 months
6. Children have not taken part in a trauma recovery intervention in the last 12 months
All children that meet this criteria will be included, except children with high risk to self or others, as judged by school psychologists.
What does the study involve?
Schools will be randomly allocated to one of the two possible groups: the intervention group will be offered the TRT+P programme and the waitlist-control group will receive services as usual, followed by the TRT+P programme around 20 weeks later. Outcome data will be collected at three points: pre-intervention (T1), post-intervention (T2; about 8 weeks after randomisation) and follow-up (T3; about 20 weeks after randomisation). The objective is to evaluate whether the TRT+P programme influences child mental health, specifically symptoms of post-traumatic stress, in comparison to similar children who only receive services as usual. TRT+P -trained ‘group leaders’ (school psychologists) will deliver the intervention; two group leaders deliver each group. The study will primarily measure changes in self-reported child mental health, specifically symptoms of PTSD. Parenting and carers' symptoms of PTSD will also be measured. Outcome data will be collected using a secure online platform (Google Forms). It is estimated the CRIES-8 and demographic questionnaire will take around 10 minutes.
What are the possible benefits and risks of participating?
Young people and parents/carers will help researchers better understand the effectiveness of the intervention for young people experiencing PTSD symptoms and could help TRT+P be rolled out to other young people impacted by the recent war. The participants may become distressed during the intervention and/or completing outcome measures. Participants will be signposted to appropriate support by trained clinicians and research team members.
Where is the study running from?
The host institution is Queen Mary, University of London (UK). The study will be based in Ternopil (Ukraine).
When is the study starting and how long is it expected to run for?
December 2022 to December 2025
Who is funding the study?
Queen Mary, University of London (UK)
Other funding options are currently being considered.
Who is the main contact:
Dennis Ougrin, d.ougrin@qmul.ac.uk
Contact information
Principal Investigator
Newham Centre for Mental Health
London
E13 8SP
United Kingdom
| Phone | +44 (0)2075404210 |
|---|---|
| d.ougrin@qmul.ac.uk |
Scientific
Newham Centre for Mental Health
London
E13 8SP
United Kingdom
| Phone | +44 (0)7462528705 |
|---|---|
| wpw090@qmul.ac.uk |
Study information
| Study design | Cluster randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | School |
| Study type | Treatment |
| Participant information sheet | 43352 Ukrainian PIS_.pdf |
| Scientific title | Evaluation of the Teaching Recovery Techniques plus Parenting, a Cluster Randomised Controlled Trial in Ukrainian Schools in Ternopil (TRUST) |
| Study acronym | TRUST |
| Study hypothesis | Current study hypothesis as of 23/11/2023: The objective of the trial is to evaluate whether the Teaching Recovery Techniques Plus Parenting (TRT+P) programme influences child mental health, specifically symptoms of post-traumatic stress, in comparison to similar children who only receive services as usual. Previous study hypothesis: The objective of the trial is to evaluate whether the Teaching Recovery Techniques Plus Parenting (TRT+P) programme influences child mental health, specifically symptoms of post-traumatic stress, anxiety and depression, in comparison to similar children who only receive services as usual. |
| Ethics approval(s) |
Approved 21/11/2024, Ethics committee of Volodymyr Ternopil National Pedagogical University (2, Maksyma Kryvonosa St, Ternopil, 46000, Ukraine; +38(0352)43-58-80; pk@tnpu.edu.ua), ref: None provided |
| Condition | Young children screening positive for PTSD. |
| Intervention | A cluster randomized controlled trial will be conducted in which schools will be randomly allocated using an open-source randomization platform to one of the two possible arms: the intervention arm (generating n = 113 children) will be offered the TRT+P programme and the waitlist-control arm (n = 113) will receive services as usual, followed by the TRT+P programme around 20 weeks later. The intervention is 5 weeks long. Outcome data will be collected at three points: pre-intervention (T1), post-intervention (T2; about 8 weeks after randomisation) and follow-up (T3; about 20 weeks after randomisation). |
| Intervention type | Behavioural |
| Primary outcome measure | Parent-reported or self-reported child mental health, specifically symptoms of PTSD measured using the Children’s Revised Impact of Event Scale (CRIES-8) at three points: pre-intervention (T1; baseline), post-intervention (T2; c. 8 weeks after randomisation) and follow-up (T3; c. 20 weeks after randomisation) |
| Secondary outcome measures | Current secondary outcome measures as of 23/11/2023: There are no secondary outcome measures _____ Previous secondary outcome measures: All outcome data will be collected at three points: pre-intervention (T1; baseline), post-intervention (T2; c. 8 weeks after randomisation) and follow-up (T3; c. 20 weeks after randomisation): 1. Symptoms of anxiety measured using the Screen for Childhood Anxiety-Related Disorders (SCARED) five-item version 2. Depression measured using the Depression Self-Rating Scale for Children (DSRS) 3. Parenting measured using the Parenting and Family Adjustment Scale (PAFAS) 4. Carers' symptoms of PTSD measured using the Impact of Events Scale Revised (IES-R) 5. Depression, anxiety and stress among caters measured using the Depression Anxiety and Stress Scale (DASS 21) |
| Overall study start date | 01/12/2022 |
| Overall study end date | 30/12/2025 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Upper age limit | 13 Years |
| Sex | Both |
| Target number of participants | 226 |
| Participant inclusion criteria | 1. The child is aged 8 to 13 years old 2. The child screens positive on the Children’s Revised Impact of Event Scale (CRIES-8) PTSD screening tool (≥17 points) 3. The child is interested to participate in a group intervention 4. The legal guardian does not object to participation and a parent or other primary caregiver wishes to participate 5. The participating caregiver has not taken part in another parenting programme in the past 12 months 6. Children have not taken part in a trauma recovery intervention in the last 12 months |
| Participant exclusion criteria | Severe mental health disorders requiring specialist treatment |
| Recruitment start date | 01/02/2024 |
| Recruitment end date | 01/09/2025 |
Locations
Countries of recruitment
- Ukraine
Study participating centre
Ternopil
46000
Ukraine
Sponsor information
University/education
Mile End Rd
Bethnal Green
London
E1 4NS
England
United Kingdom
| Phone | +44 (0)20 7882 5555 |
|---|---|
| jrmo@qmul.ac.uk | |
| Website | https://www.qmul.ac.uk |
"ROR" |
https://ror.org/026zzn846 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- Queen Mary Uni of London, Queen Mary, Queen Mary and Westfield College, QMUL, QM
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/07/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generation during and/or analysed during the current study are not expected to be made available due to confidentiality issues. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 22/03/2023 | No | No | ||
| Participant information sheet | in Ukrainian | 23/11/2023 | No | Yes | |
| Protocol file | version 1.2 | 23/11/2023 | No | No |
Additional files
Editorial Notes
26/03/2024: Ethics approval was added.
01/12/2023: The plain English summary was updated to reflect the changes made on 23/11/2023.
23/11/2023: The following changes were made to the trial record:
1. Uploaded protocol v1.2 (not peer-reviewed) as an additional file.
2. The participant information sheet was uploaded as an additional file.
3. The scientific title was changed from "Evaluation of the Teaching Recovery Techniques Plus Parenting skills-focused intervention for Ukrainian children experiencing post-traumatic stress symptoms: a cluster randomized controlled trial" to "Evaluation of the Teaching Recovery Techniques plus Parenting, a Cluster Randomised Controlled Trial in Ukrainian Schools in Ternopil (TRUST)".
4. The public title was changed from "The effectiveness of Teaching Recovery Techniques Plus Parenting for Ukrainian children experiencing post-traumatic stress symptoms" to "Evaluation of the Teaching Recovery Techniques plus Parenting, a Cluster Randomised Controlled Trial in Ukrainian Schools in Ternopil (TRUST)".
5. The acronym was changed from ETU to TRUST.
6. The study hypothesis was changed.
7. The overall end date was changed from 30/11/2025 to 30/12/2025.
8. The secondary outcome measures were changed.
9. The recruitment end date was changed from 01/07/2025 to 01/09/2025.
25/04/2023: Trial's existence confirmed by Queen Mary University of London.
