Online integrated bipolar parenting intervention study
| ISRCTN | ISRCTN15962574 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15962574 |
| IRAS number | 309190 |
| Secondary identifying numbers | IRAS 309190, NIHR131483, CPMS 53926 |
- Submission date
- 31/03/2023
- Registration date
- 03/05/2023
- Last edited
- 19/02/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Parents with bipolar disorder (BD) find that the ups and downs of mood that they experience make parenting very challenging, particularly in providing the consistent support and guidance children need. Parents with BD want parenting support but worry they might lose access to their children if they disclose this to their clinicians. Accessible, flexible, and confidential online parenting support is a way to provide this without adding to worries parents already have. Children of parents with BD often have emotional and behavioural problems, which can lead to severe mental health problems, including BD, as they grow up. Parents need support to help their children flourish, which may help parents themselves feel better as well, with wider benefits for society. Researchers have built an online intervention to support parents with BD which was acceptable to parents and helped with child emotional and behavioral problems and with parenting. They now need to fully assess whether an updated version of this intervention is effective and represents value for money.
The aim of this study is to assess whether providing parents with bipolar disorder (BD) with online parenting support leads to their children having fewer behaviour problems. The researchers also want to know whether this helps parents feel less stressed and more confident about their parenting. They will also explore whether the intervention leads to parents having fewer mood or anxiety problems.
Who can participate?
Parents who experience bipolar disorder and have at least one child between the ages of 4-10 years old. Participants must be UK residents and will need access to an internet-enabled computer, tablet, or mobile phone.
What does the study involve?
The screening process involves taking part in a 15-minute initial call and then an eligibility check which will last around 2 hours. Once confirmed as eligible, participants will be involved in the study for 48 weeks. They will be asked to fill in measures when they join the study, again after 24 weeks, and then again at the end of their involvement after 48 weeks. Participants will be randomly allocated to either receive access to IBPI and continue their treatment as usual, or to the control group where they will have access to a web page providing information on sources of support for bipolar and parenting but no additional material beyond their treatment as usual. The surveys sent to both study groups are the same.
What are the possible benefits and risks of participating?
There may be potential benefits from using IBPI for children's emotional and behavioural problems, as well as for parenting outcomes. There is a chance participants will find no direct benefit to themselves, but it is hoped that participants will find the information in the study helpful is interesting to engage with. It is also hoped that they feel like they’ve made an important contribution to research aimed at improving support for parents with bipolar disorder and their families. There are no direct risks anticipated with participating in this study.
Where is the study run from?
The core trial team are based at Lancaster University (UK). This is a remote digital trial so participants will not need to travel anywhere to take part.
When is the study starting and how long is it expected to run for?
April 2022 to March 2026
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)
Who is the main contact?
Lucy Cryle (Trial Manager) and Stephanie Fortier (Research Assistant), ibpi@lancaster.ac.uk
Contact information
Principal Investigator
The Spectrum Centre
Division of Health Research
Sir John Fisher Drive
Lancaster
LA1 4AT
United Kingdom
 ORCID ID |
0000-0002-8801-5113 |
|---|---|
| Phone | +44 (0)7872464198 |
| s.jones7@lancaster.ac.uk |
Study information
| Study design | Online randomized effectiveness and cost-effectiveness trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Treatment |
| Participant information sheet | 43420_PIS_V9.1_12Jan23.pdf |
| Scientific title | Clinical and cost-effectiveness of an online integrated bipolar parenting intervention: a randomized controlled trial |
| Study acronym | IBPI |
| Study hypothesis | It is hypothesised that an integrated bipolar parenting intervention (IBPI) plus treatment as usual will improve child emotional and behavioural difficulties compared to treatment as usual. |
| Ethics approval(s) | Approved 31/10/2022, West Midlands – Solihull Research Ethics Committee (Equinox House, City Link, Nottingham, NG2 4LA, UK; +44 (0)2071048269; solihull.rec@hra.nhs.uk), ref: 22/WM/0200 |
| Condition | Bipolar disorder |
| Intervention | Parents with BD with a child aged 4-10 years old in the UK will be invited to participate through UK NHS mental health trusts, mental health charities and social media. Parents who agree to take part will be either offered the online intervention or usual care. Whether the parent receives the intervention or not is decided by randomisation (like a coin toss). Randomisation will be conducted using an online system (within the REDCap Cloud electronic data capture system) set up by York Clinical Trials Unit. Participants will be allocated (1:1 ratio) to the two trial arms using stratified randomisation. Participants will be stratified based on the number of previous bipolar episodes (three levels; 1-7, 8-19, or >=20), and whether or not their partner is receiving mental health care (three levels; yes, no or n/a - no partner). The Integrated Bipolar Parenting Intervention (IBPI) is an online tool that combines parenting support with helpful strategies for managing bipolar. It has nine modules, including topics such “anxiety”, “sleep”, “perfectionism, impulsivity, and supporting your child to learn new skills”. Sections take around 30 minutes each to complete and parents are free to access them whenever they want. IBPI can be accessed 24/7 through computers, mobile phones or tablets connected to the internet. Parents will fill in questionnaires about their child, their parenting, their mood and anxiety when they start the study and at 24 and 48 weeks. Up to 30 parents will be interviewed after taking part in the intervention to learn their views. |
| Intervention type | Behavioural |
| Primary outcome measure | The child’s behavioural and emotional wellbeing is measured using the Strengths and Difficulties Questionnaire (SDQ) at 0, 24 and 48 weeks. The primary outcome is SDQ at 24 weeks. This will be completed by the parent about the index child. |
| Secondary outcome measures | 1. Clinical: Child behavioural and emotional problems at 48 weeks, Parenting stress, confidence, and competence 2. Parental Mood: Family Functioning 3. Health Cost: Measures of parent-reported child and parent quality of life and cost at 24 and 48 weeks 4. Qualitative: Participants’ views on the intervention 1. Behavioural and emotional wellbeing of non-index children (any other eligible children aged 4-10 who parents spend 10+ hours a week with) assessed using the SDQ at 0, 24 and 48 weeks 2. Parenting stress and competency measured using the Parenting Sense of Competence Scale (PSOC), Parenting Scale (PS) and Parenting Stress Index Short Form (PSI-4-SF) at 0, 24 and 48 weeks 3. Parental mood measured with the Internal States Scale (ISS), the Centre for Epidemiologic Studies Depression Scale (CES-D), the Altman Self Rating Mania Scale (ASRM), the Generalised Anxiety Disorder Scale (GAD-7), and the National Institute of Mental Health’s Self-Rated Retrospective Life Chart Method (LCM) at 0, 24 and 48 weeks 4. Family functioning measured with the Confusion, Hubbub and Order Scale (CHAOS-9) at 0, 24 and 48 weeks 5. Cost-effectiveness determined from a societal perspective using the Child and Adolescent Service Use Schedule (CA-SUS) and the CARER-SUS in which parents will report on both their child’s and their own use of health, social, and educational services, as well as time off work for parents in employment. These will be completed by parents at 0, 24 and 48 weeks. 6. Parent-reported child and parent quality of life (CHU-9D; EQ-5D-3L) and cost (CA-SUS; CARER-SUS). Using these measures, the researchers will determine quality-adjusted life years (QALYS) for parents (EURO-QOL Research Group, 2018) and children (Stevens, 2012). These will be completed by parents at 0, 24 and 48 weeks. 7. Demographic information about the parent and their index child collected via self-report questionnaires at 0 weeks only Feedback interviews Following the completion of the Internal Pilot, a subset of participants (n = 30) will be selected and invited to participate in a feedback interview. This will only apply to participants from the IBPI + TAU arm, not from the TAU arm. Participants will be selected with maximum variance sampling on stratification factors and levels of intervention use for feedback interviews. The topic guide for these interviews will include questions surrounding participants’ perceptions of what has changed following IBPI, the factors which influenced their level of engagement, and their recommendations for improvement. |
| Overall study start date | 01/04/2022 |
| Overall study end date | 31/03/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 4 Years |
| Upper age limit | 10 Years |
| Sex | Both |
| Target number of participants | 342 |
| Participant inclusion criteria | 1. Bipolar diagnosis of parent confirmed by structured clinical interview 2. Have a child aged 4-10 years with ≥10 hours of face-to-face contact weekly 3. Internet access 4. Ability to provide informed consent 5. Resident in the UK |
| Participant exclusion criteria | 1. Primary parent diagnosis of alcohol/other substance misuse 2. Parents already receiving a parenting intervention and/or intensive psychotherapy 3. Index child in receipt of current psychological therapy 4. Child subject to child protection proceedings |
| Recruitment start date | 07/03/2023 |
| Recruitment end date | 30/11/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Lancaster
LA1 4YW
United Kingdom
Sponsor information
University/education
University House
Bailrigg
Lancaster
LA1 4YT
England
United Kingdom
| sponsorship@lancaster.ac.uk | |
| Website | https://www.lancaster.ac.uk/ |
"ROR" |
https://ror.org/04f2nsd36 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/03/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The researchers will disseminate findings to academic audiences, service user/carer organisations, NHS Trusts, and policy-makers particularly the Department of Health and Social Care and NHS England as follows: 1. A definitively-tested and implementation-ready online psychoeducation and parenting intervention for parents with bipolar (IBPI) 2. Papers on the clinical and cost-effectiveness of IBPI published in high-impact academic peer-reviewed journals (e.g., Lancet Psychiatry) 3. Lay articles published through websites, magazines, conferences and other publications produced by service user groups such as Bipolar UK, Mind, Depression Alliance, Young Minds, NSUN, and ReThink 4. National and international conference presentations for academics, service users, and carers. Outcomes will be disseminated to influential stakeholder groups including annual conferences of the medical and psychological colleges and associations. The researchers will disseminate through service user and relatives’ organisations including Bipolar UK, MIND and Rethink and the Recovery Colleges covering two-thirds of NHS Trusts in England and AHSNs. 5. A project-specific website and Twitter feed will be updated throughout the programme, including links to lay and expert summaries of findings when published. 6. A full report for the NIHR HTA journal. 7. Summary of research findings for participants including an accessible animation of the purpose and outcomes of the research will be made freely available through the project website and shared directly with participants by email with links. The impact of the study will, in the first instance, be on the 342 participants and their children in the study. The feasibility study indicated some potential benefits in both arms for participants. However, the clearest benefits were for those in the IBPI arm suggesting the potential for a significant impact on child and parenting outcomes in the 168 participants and their families from that arm. The researchers will work with all relevant stakeholders (clinical, academic, voluntary sector, service users and their relatives/friends) throughout the project to ensure IBPI is implementation ready on completion. A problem with many online interventions is that they are often not successfully implemented. To address this, the researchers have partnered with LSCFT (NHS global digital exemplar) to host, promote and maintain the site post-study with the support of Bipolar UK. LSCFT will be supported by other partners in Healthier Lancashire and South Cumbria Integrated Care System through their ‘Our digital future’ programme. Working with NHSX from the outset will also ensure IBPI’s success in national dissemination and that it meets the criteria for the NHSX app library. This will ensure a rapid national rollout of this intervention at the completion of the study to benefit the many high-risk children and their parents in the UK. The researchers have extensive links with NHS England and Health Education England including with programmes to increase access to psychological support for people with bipolar. This intervention will be an important tool that clinicians can refer to as the sole tailored intervention to support parents with bipolar disorder and their children. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 9.1 | 12/01/2023 | 24/04/2023 | No | Yes |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
19/02/2025: The recruitment end date was changed from 31/01/2025 to 30/11/2025.
12/06/2024: The recruitment start date was changed from 01/02/2023 to 07/03/2023.
24/04/2023: Trial's existence confirmed by the NIHR.
