Feasibility study of an integrated parenting intervention
| ISRCTN | ISRCTN71853873 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71853873 |
| Secondary identifying numbers | LTP+1 |
- Submission date
- 04/02/2021
- Registration date
- 11/03/2021
- Last edited
- 22/04/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
A recent report of the United Nations Human Rights Council (2019) estimates that there are currently 70.8 million forcibly displaced people worldwide. As documented by several studies, this group is at great risk of having mental health difficulties. The mental health difficulties of parents not only influence themselves but also children’s mental health. The transition of mental health difficulties through harsh parenting highlights the importance of family-level interventions rather than individual-level interventions. Targeting parenting skills might reduce the impact of the displacement on the mental health of children. This study will offer an online group parenting intervention to parent refugees and asylum seekers to improve their parenting satisfaction by addressing mental health difficulties
Who can participate?
Parent refugees and asylum seekers aged over 18 with young children (aged under 3)
What does the study involve?
Participants will attend eight weekly online group parenting intervention and complete several scales to test the feasibility of the intervention. The intervention Learning Through Play (LTP) will be delivered to parent refugees in conjunction with EMDR Group Treatment Protocol (EMDR-GTEP). LTP aims to enable parents to improve their child’s psychosocial development by increasing awareness about child development and the importance of play activities.
What are the possible benefits and risks of participating?
Potential benefits to research participants will be improving parenting skills and mental well-being. In addition to that, participants may experience some positive benefits from knowing that they are contributing to the development of new therapies for their communities. Previous research has also shown that taking part in mental health research can have positive effects for participants, including positive feelings of catharsis and being able to help others. Participants will also be reimbursed for their time.
Where is the study run from?
University of Manchester (UK)
When is the study starting and how long is it expected to run for?
February 2021 to March 2022
Who is funding the study?
Turkish Embassy Education Counsellor's Office (UK)
Who is the main contact?
Safa Kemal Kaptan
Safa.kaptan@manchester.ac.uk
Contact information
Scientific
Global Mental Health and Cultural Psychiatry Research Group
Complex Trauma and Resilience Research Unit
Division of Psychology and Mental Health
University of Manchester
Jean Macfarlane Building, 3.306
Manchester
M13 9PY
United Kingdom
 ORCID ID |
0000-0002-4709-6543 |
|---|---|
| Phone | +44 (0)7404791100 |
| safa.kaptan@manchester.ac.uk |
Study information
| Study design | Online feasibility trial with pre- and post-intervention assessment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Feasibility trial of learning through play parenting intervention integrated with eye movement desensitization and reprocessing group traumatic episode protocol (LTP + EMDR G-TEP) |
| Study acronym | LTP + EMDR G-TEP |
| Study objectives | To assess the feasibility and acceptability of the group parenting intervention. |
| Ethics approval(s) | Approved 04/02/2021, The University of Manchester Research Ethics Committee 1 (Research Governance, Ethics and Integrity, 2nd Floor Christie Building, The University of Manchester, Oxford Road, Manchester, M13 9PL, UK; +44 (0)161 275 2206/2674; research.ethics@manchester.ac.uk), ref: 2021-10701-17718 |
| Health condition(s) or problem(s) studied | Parenting sense of competence, depression, anxiety, stress |
| Intervention | LTP+ EMDR G-TEP is a manual assisted integrated parenting psychological intervention. LTP is based on the principles of attachment theory which is integrated with EMDR. The intervention will be delivered in eight sessions over 3 months. The first four sessions are offered weekly and further sessions fortnightly and each session lasting about 60 minutes. LTP+ EMDR G-TEP has two components: Component 1 is Learning Through Play (LTP) aims to promote healthy child development by improving parents’ mental health and strengthening attachment between parents and their children. The LTP manual covers the physical and psychological development of children and the importance of parent-child play. The key feature of LTP is the pictorial calendar. The calendar contains illustrations of play activities, enables parents to understand how attachment works. LTP is a low-cost intervention since homemade toys and materials are used to keep costs down to the minimum. The program can be easily delivered to disadvantaged groups as it does not require participants to possess formal education. Component 2 is Eye Movement Desensitization and Reprocessing Group Traumatic Episode Protocol (EMDR G-TEP). EMDR G-TEP is a group psychotherapy intervention. It is aimed at adolescents and adults. The group protocol covers the core principles of standard individual EMDR therapy with special attention to stabilization and positive future resources. |
| Intervention type | Behavioural |
| Primary outcome measure | Measured at baseline (pre-trial) and post-trial: 1. PTSD assessed using the International Trauma Questionnaire 2. Anxiety assessed using the Generalized Anxiety Disorder 7-item (GAD-7) Scale 3. Depression assessed using the Patient Health Questionnaire-9 (PHQ-9) 4. Parenting skills assessed using the Parenting Sense of Competence Scale |
| Secondary outcome measures | 1. Dissociative experiences measured using Dissociative Experiences Scale - II at baseline 2. Participants’ satisfaction with the intervention measured using Client Satisfaction Questionnaire (CSQ-8) at post-intervention |
| Overall study start date | 04/02/2021 |
| Completion date | 01/03/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 8-10 |
| Key inclusion criteria | 1. Over 18 years old 2. Able to provide informed written consent and to speak English 3. No restriction related to ethnicity, medical conditions will be applied 4. Being a refugee or asylum seeker 5. Being a parent 6. Registered with GP |
| Key exclusion criteria | 1. Age below 18 years old 2. Not able to provide informed written consent and to speak, read, and understand English 3. Refugees or asylum seekers who are not parents |
| Date of first enrolment | 22/05/2021 |
| Date of final enrolment | 01/11/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Manchester
M13 9PL
United Kingdom
Sponsor information
Government
First Floor
5-15 Cromer St
London
WC1H 8LS
United Kingdom
| Phone | +44 (0)20 3875 9551 |
|---|---|
| burslu_londra@meb.gov.tr | |
| Website | http://londra.meb.gov.tr/ |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/01/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Once the study receives ethical approval the protocol will be published in a peer-review journal. Findings will also be submitted to a peer-review journal and relevant conferences. Finally, the study will form a chapter in the PhD thesis. |
| IPD sharing plan | The datasets will be available from the corresponding author on reasonable request immediately after publication from Safa Kemal Kaptan (safa.kaptan@manchester.ac.uk). Type of data: repeated measures data Data will become available: indefinitely Data will be shared with researchers for example for meta-analysis purposes or verifying the conducted analyses Access criteria: upon request Participants will give informed consent to use the anonymized data for research purposes |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 23/12/2021 | 22/04/2022 | Yes | No |
Editorial Notes
22/04/2022: Publication reference added.
18/10/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/09/2021 to 01/11/2021.
2. The overall end date was changed from 01/12/2021 to 01/03/2022.
3. The plain English summary was updated to reflect these changes.
27/07/2021: The following changes were made to the trial record:
1. The recruitment start date was changed from 05/02/2021 to 22/05/2021.
2. The recruitment end date was changed from 01/04/2021 to 01/09/2021.
3. The overall trial end date was changed from 01/10/2021 to 01/12/2021.
10/03/2021: Trial's existence confirmed by The University of Manchester Research Ethics Committee 1.
