Condition category
Mental and Behavioural Disorders
Date applied
08/07/2013
Date assigned
12/08/2013
Last edited
12/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The study aims to determine whether it would be useful to adapt an existing parenting programme called Triple P Online to include specific information and ideas for parents with a mental disorder called 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.

Who can participate?
People with a diagnosis of bipolar disorder who are 18 years or over with at least one child aged between 3 and 10 years old and have internet access can participate in this study.

What does the study involve?
A member of our research team will arrange a time for an interview which will take place over the phone. Initially, we will ask some questions to confirm eligibility for the study. The study requires that a bipolar disorder diagnosis is verified using an interview. This will be conducted with all participants, unless this assessment has occurred during a previous study by the Spectrum Centre for Mental Health Research within the last 6 months. The interview takes about 1 hour and 15 minutes to complete over the telephone. Participants will be randomly 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 care offered to the first group. All participants in the second group will be given access to the site following the conclusion of the study if it is found to be helpful or cause no harm. IBPI consists of 16 modules. It is designed so that one module is completed each week over a period of 4 months. Each module may take an hour to complete online and then involve planning activities during the subsequent week. If participants have more than one child they are required to pick one to focus on during completion of the programme. All participants will be asked to complete three telephone interviews during the 12 months of their study participation (upon joining, and then after 6 and 12 months). These telephone interviews will take about 45 minutes to complete. Participants will also be asked to complete a number of questionnaires on five separate occasions (upon joining, and then after 4, 6, 9 and 12 months). The majority of these will be completed online, but one will be via telephone. The online questionnaires will take about an hour to fill in and the questionnaire completed over the phone will take about 5 minutes. Up to 10 parents can participate in an interview following the programme to express their views on IBPI, including elements that they found helpful as well as any challenges to using the web programme. Fifteen children of the parents involved in the study can take part in two interviews, once before and once after their parents' completion of the programme to find out about the children's emotions and their experience of family life. The interviews for parents will last about an hour and the interviews for the children will last about 45 minutes. The children's interviews will involve using a programme 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.

What are the possible benefits and risks of participating?
By participating in the study there is an opportunity to get support 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 programme, 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 and thereby have a direct influence on the development of the programme. This study 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 of concerns, the research team can be contacted directly and a list of support organisations will be supplied to all participants.

Where is the study run from?
This study is run from The Spectrum Centre for Mental Health Research at Lancaster University, UK.

When is the study starting and how long is it expected to run for?
Participants will be recruited up until January 2014.

Who is funding the study?
This study is funded by the Medical Research Council, UK.

Who is the main contact?
Professor Steven Jones
Telephone: 01524 593756
Email: s.jones7@lancaster.ac.uk

Trial website

http://www.ibpi.co.uk

Contact information

Type

Scientific

Primary contact

Prof Steven Jones

ORCID ID

Contact details

The Spectrum Centre for Mental Health Research
Lancaster University
Lancaster
LA1 4YW
United Kingdom
-
s.jones7@lancaster.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MR/J011886/1

Study information

Scientific title

An exploratory randomised controlled trial of a web-based Integrated Bipolar Parenting Intervention (IBPI) for bipolar parents of young children (aged 3-10)

Acronym

IBPI

Study hypothesis

To develop an Integrated Bipolar Parenting Intervention by combining informative material about Bipolar Disorder with an existing parenting intervention, Triple P Online, in consultation with a Service User Research Group consisting of individuals including parents with Bipolar Disorder and carers of people with Bipolar Disorder.

Ethics approval

NRES Committee North West - Greater Manchester East, 27/11/2012, REC ref: 12/NW/0749

Study design

Randomised Intervention; Design type: Web-based Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Participant information can be found at http://www.ibpi.co.uk/participant_information

Condition

Bipolar Disorder

Intervention

1. Intervention arm: Web-based integrated bipolar parenting intervention comprising the online Triple P parenting intervention alone. The intervention has been developed through collaboration between a multidisciplinary group of mental health professionals and service users with experience of bipolar disorder

Focus groups have taken place with individuals who took part in the first phase of the project (the qualitative analysis of recovery themes) to ensure that the intervention is appropriate and acceptable to individuals early in the course of bipolar disorder. Furthermore, a service user consultation group have also been provided.

2. Treatment as Usual Arm (TAU)

Follow Up Length: 12 months

The Intervention arm will receive the IPBI intervention for 4 months and then get follow-up at 4, 6, 9 and 12 months. The other arm of the trial is the Treatment as Usual Arm (TAU) they will be followed up at the same time points.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Feasibility (Recruitment figures) measured at Baseline
2. Feasibility (Retention figures) measured at 12-months post randomization
3. Acceptability (website usage data) measured during intervention
4. Acceptability (qualitative interviews) measured 4-months post randomization

Secondary outcome measures

1. Strengths and Difficulties Questionnaire (SDQ)- Child Behaviour, measured at Baseline, End of intervention (4 months), and 6-, 9-, and 12-months post randomization.
2. Eyberg Child Behavior Inventory (ECBI) - Child Behaviour, measured at Baseline, End of intervention (4 months), and 6-, 9-, and 12-months post randomization.
3. Parenting Scale (PS3) - Parenting, measured at Baseline, End of intervention (4 months), and 6-, 9-, and 12-months post randomization.
4. Parenting Sense of Competancy Scale PSOC) – Parenting, measured at Baseline, End of intervention (4 months), and 6-, 9-, and 12-months post randomization.
5. Parenting Stress Index (PSI) – Parenting, measured at Baseline, End of intervention (4 months), and 6-, 9-, and 12-months post randomization.

Tertiary outcome measures
1. Internal States Scale (ISS) - Parent symptoms, measured at Baseline, End of intervention (4 months), and 6-, 9-, and 12-months post randomization.
2. Centre for Epidemiologic Studies Depression Scale (CES-D)- Parent symptoms, measured at Baseline, End of intervention (4 months), and 6-, 9-, and 12-months post randomization.
3. Altman Mania Rating Scale (AMRS) - Parent symptoms, measured at Baseline, End of intervention (4 months), and 6-, 9-, and 12-months post randomization.
4. Confusion, Hubbub and Order Scale (CHAOS) - Parent symptoms, measured at Baseline, End of intervention (4 months), and 6-, 9-, and 12-months post randomization.
7. Structured Clinical Interview for DSM-IV-TR AXIS 1 DISORDERS - LIFE (SCID-LIFE)- Parent Symptoms, measured at Baseline, 6- and 12- moths post-randomisation.
8. In My Shoes Computer Assisted Interview for Children - Child perspectives on family functioning, measured at Baseline and 4 months post randomization.

Overall trial start date

27/11/2012

Overall trial end date

03/03/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Individuals who have received a research-confirmed clinical diagnosis of bipolar disorder
2. Individuals who are parents of at least one child aged between 3 and 10
3. Individuals must have at least 10 hours of weekly contact with their child
4. Can provide written informed consent
5. Can communicate in English
6. Have access to the internet and a telephone

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Individuals who are currently experiencing or have experienced within the last month, an acute episode of major depression or mania
2. Individuals referred into the study during an acute episode will wait until they have been out of episode for one month before entering the study. Nevertheless, it is expected that most participants will have subsyndromal mood symptoms.

Recruitment start date

27/11/2012

Recruitment end date

01/01/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Spectrum Centre for Mental Health Research
Lancaster
LA1 4YW
United Kingdom

Sponsor information

Organisation

Lancaster University (UK)

Sponsor details

c/o Professor Trevor McMillan
Bailrigg
Lancaster
LA1 4YT
United Kingdom
+44 (0)1524 592054
t.mcmillan@lancaster.ac.uk

Sponsor type

University/education

Website

http://www.lancaster.ac.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK) Grant Code: MR/J011886/1

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26047808

Publication citations

Additional files

Editorial Notes