If you are interested in the study, before you decide whether you would like to take part, it is important that you understand why this research is being carried out and what it will involve. Please take the time to read the following information carefully and discuss this with others if you wish. Please ask us if there is anything that is unclear or that you would like more information about. Take time to decide whether or not you wish to take part.
- Who can take part in the study?
- What is this study aiming to do?
- Who is organising the research?
- Who will be taking part?
- What are the advantages and disadvantages of taking part?
- Do I have to take part and what if I change my mind?
- What does participating in the study involve?
- Will my data be confidential?
- What will happen to the results of the research?
- Where can I obtain further information about the study if I need it?
- How do I make a complaint?
In order to take part you must meet all of the following requirements: -
- Have a diagnosis of bipolar disorder
- Be 18 years old or over
- Have at least one child aged between 3 and 10 years old
- Have an average of over 10 hours face to face contact with your child each week
- Have access to the Internet
Unfortunately, parents who are currently receiving a parenting intervention, intensive psychotherapy or have a primary diagnosis of alcohol or other substance misuse are not eligible to take part. The child you wish to focus on during the study (if you have more than one child) cannot be in current receipt of any intensive structured psychological therapy and/or currently be the subject of child protection proceedings; they also cannot have a significant learning disability or major physical illness.
The study aims to determine whether it would be useful to adapt an existing parenting intervention called Triple P Online, to include specific information and ideas for parents with bipolar disorder. This has the potential to improve the parenting experience for both parents and children and reduce the possibility of future problems for children of bipolar parents.
This project is being organised by a team of researchers, service users, relatives and academics from The Spectrum Centre for Mental Health Research at Lancaster University.
Up to 100 parents with bipolar disorder from within the UK will take part in the study.
By participating in the study you have the opportunity to access support (an internationally recognised evidence based parenting intervention) that has been shown to be effective in previous studies combined with a package of support materials for bipolar disorder drawing on our expertise of developing and evaluating interventions. All participants will be given the access to the intervention although for some participants, this will be at the end of the study rather than at the beginning. Some participants will also have the opportunity to participate in interviews to give feedback on their experiences of using the intervention and thereby have a direct influence on the development of the intervention.
The bipolar disorder intervention encourages participants to think about their past experiences and it is possible that thinking about these may result in some distress. The research team are sensitive to this and an online parent support group (peer support forum) is available to support discussion of this. In the event that you have concerns, the research team can be contacted directly and a list of support organisations is supplied to all participants.
It is completely up to you to decide whether or not you would like to take part. If you do decide to take part you will be given a copy of this information sheet and asked to sign a consent form. If you do decide to take part but change your mind later, you are free to withdraw at any time and do not need to give us a reason. If you decide to withdraw from the qualitative interview part of the study, you may do so up to two weeks after taking part as it will not be practical to remove your data after this point. If you decide not to take part, or to withdraw during the study, this will not affect the standard of care you receive or your ability to take part in future research with the Spectrum Centre.
If you do decide to take part in the study, a member of our research team will arrange a time to come and meet you, either at home or at another place where you feel comfortable or if you prefer the interview can take place over the phone. Initially, we will ask you some questions about you to confirm that you meet the inclusion criteria for the study.
The study requires that your bipolar disorder diagnosis is verified using an interview. This is referred to as a structured diagnostic interview and is called the SCID DSM-IV. This will be conducted with all participants, unless you have already had this assessment during a previous study by the Spectrum Centre for Mental Health Research within the last 6 months. In that case, you have the option to sign an additional consent form providing the research team with your existing SCID record held at the Spectrum Centre for Mental Health Research. Alternatively, you can choose to have the SCID interview performed again. The SCID interview will take approximately 1 hour and 15 minutes to complete.
If you are under the care of a mental health NHS trust, a copy of your consent form will be copied into your usual medical notes and this copy may be reviewed by the Trust Clinical Audit Department to confirm that you have given written consent to take part. We will also ask for your permission to contact your Care Coordinator/GP to ask them some questions about your diagnosis and inform them that you are taking part in this project.
Participants will be placed in one of two groups. One group will be provided with access to the Integrated Bipolar Parenting Intervention (IBPI) and should continue with any other treatments or care plans in place. The second group will not have access to the site during the period of the study. This group is vital to the success of the study as it will allow us to assess the effectiveness of the interventions offered to the first group. All participants in the second group will be given access to the intervention following the conclusion of the study if the intervention is found to be helpful or cause no harm.
Those participants in the first group will be given access to IBPI which consists of 16 modules. It is designed so that one module is completed each week over the 4 months of the intervention. Each module may take an hour to complete online and then involve planning activities or reflection during the subsequent week. If participants have more than one child they are required to pick one to focus on during completion of the program.
All participants will be asked to complete 3 telephone interviews during the 12 months of their study participation (upon joining, and then after 6 and 12 months). They will also be asked to complete a number of online questionnaires on 5 separate occasions (upon joining, and then after 4, 6, 9 and 12 months). The telephone interviews will take approximately 45 minutes to complete and the online questionnaires will take approximately 1 hour to fill in.
Up to 10 parents are able to participate in a qualitative interview following the intervention to ascertain impressions of the IBPI, including elements that they found helpful as well as any challenges to using the web-program. 15 children of the parents involved in the study are also able take part in 2 qualitative interviews, once before and once after their parents completion of the program to generate data about children’s emotions and their experience of family life. Both parents and children will be invited to participate in these qualitative interviews based on the research team’s assessment of their potential contribution to the development of the intervention. Thus not everyone who wishes to take part of these interviews will be able to do so, this is due to the fact a range of perspectives is being sought. The qualitative interviews for parents will last approximately 1 hour and the qualitative interviews for the children will last approximately 45 minutes. The children’s interviews will involve using a program called ‘In My Shoes’ (IMS), which is a computer assisted interview for communicating with children. All interviews will take place in participant’s homes and will be recorded as long as specific consent has been obtained.
Participants will receive a payment of £10 for each SCID telephone interview they complete during the study. Anyone who takes part in the qualitative interview will receive an extra payment of £10. All children who take part in their 2 qualitative interviews will receive a £10 voucher on each occasion in order to thank them for their help.
All information collected for the project will be stored in a password protected database accessible only by key research personnel on the study. Paper forms will be stored in a locked filing cabinet at Lancaster University accessible only to these key research personnel. Your rights concerning this information are protected under the 1998 Data Protection Act. Lancaster University may access copies of the consent forms for research governance audits. This study will provide a unique set of data and as such anonymised data will be kept for a period of 20 years after completion to allow opportunities for revisiting and reappraising the data.
All the information that you give will be strictly confidential. This information will be disclosed only with your permission or except as required by law. For example, if you share information that leads a member of our staff to be concerned about your (or another person’s) safety/ wellbeing/ involvement in criminal activity, then we may have a legal obligation to disclose this information (e.g. to a health/ social care provider; family member; emergency services). If there is a need to disclose risk related information, where possible, our staff will let you know what information needs to be shared, and with whom. We would also be under an obligation to follow child protection procedures if serious concerns about a child came to light.
If you participate in the study you will be informed of the results. The findings will be submitted for publication in high impact academic journals, for presentation at conferences, and via NHS trusts with the aim of reaching a range of mental health professionals, relatives and service users. The findings will also be submitted to voluntary organisations and service user groups in order to inform their membership.
If results are positive, further funding will be sought for a large Randomised Controlled Trial. This will formally assess effectiveness and cost-effectiveness, and further investigate how to improve the intervention. The aim is to deliver an intervention which has been shown to be effective and can be of substantial benefit to parents with bipolar disorder.
If you have any questions or comments regarding this study, please contact: -
Jelena Jovanoska, Research Associate
The Spectrum Centre, Lancaster University, Bailrigg, Lancaster, United Kingdom, LA1 4YW
Telephone: 01524 594935
If you are harmed by taking part in the research project, there are no special compensation arrangements. If you are harmed due to someone’s negligence then you may have grounds for legal action but you may have to pay for it. Regardless of this, if you wish to complain or have any concerns about any aspect of the way you have been approached or treated during the course of this study, then in the first instance please contact: -
Professor Steven Jones, Principal Investigator
Spectrum Centre for Mental Health Research, Lancaster University, Lancaster, LA1 4WY
Telephone: 01524 593756
If you would prefer to contact someone independent of the research with any concerns, please contact:
Professor Sue Cartwright, Head of Division
The Spectrum Centre, Lancaster University, Bailrigg, Lancaster, United Kingdom, LA1 4YW
Telephone: 01524 592430