Online integrated bipolar parenting intervention study

ISRCTN	ISRCTN15962574
DOI	https://doi.org/10.1186/ISRCTN15962574
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	309190
Protocol serial number	IRAS 309190, NIHR131483, CPMS 53926
Sponsor	Lancaster University
Funder	National Institute for Health and Care Research

Submission date: 31/03/2023
Registration date: 03/05/2023
Last edited: 27/08/2025

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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 the 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 4-11 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 January 2027

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

Prof Steven Jones
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
Email	s.jones7@lancaster.ac.uk

Study information

Primary study design	Interventional
Study design	Online randomized effectiveness and cost-effectiveness trial
Secondary study design	Randomised controlled trial
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 objectives	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
Health condition(s) or problem(s) studied	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 offered either 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 the 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 as “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. Updated 17/06/2025: The sample for the feedback interviews has reduced from n = 30 to up to n = 20 participants. A feedback survey has been added to the intervention arm (IBPI + treatment as usual) to supplement the reduction in the number of feedback interviews in the qualitative aspect of the trial.
Intervention type	Behavioural
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/01/2027

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	4 Years
Upper age limit	11 Years
Sex	All
Target sample size at registration	284
Key inclusion criteria	Current inclusion criteria as of 17/06/2025: 1. Bipolar diagnosis of parent confirmed by structured clinical interview 2. Have a child aged 4-11 years with ≥10 hours of face-to-face contact weekly 3. Internet access 4. Ability to provide informed consent 5. Resident in the UK Previous 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
Key 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
Date of first enrolment	07/03/2023
Date of final enrolment	30/11/2025

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Lancaster

University House
Lancaster
LA1 4YW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
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?
Protocol article		26/08/2025	27/08/2025	Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	version 9.1	12/01/2023	24/04/2023	No	Yes
Participant information sheet	version 10.0	27/03/2025	17/06/2025	No	Yes
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Additional files

43420_PIS_V9.1_12Jan23.pdf: Participant information sheet
ISRCTN15962574_PIS_V10.0_27Mar25.pdf: Participant information sheet

Editorial Notes

27/08/2025: Publication reference added.
17/06/2025: The following changes were made to the study record:
1. Protocol uploaded.
2. The upper age limit has increased to 11 years (inclusion criteria updated).
3. The target number of participants has been reduced from 342 to 284.
4. The overall study end date has been extended from 31/03/2026 to 31/01/2027.
5. The interventions were updated.
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.