ISRCTN ISRCTN10266960
DOI https://doi.org/10.1186/ISRCTN10266960
Secondary identifying numbers GR2-EVAL-112204
Submission date
15/03/2023
Registration date
20/03/2023
Last edited
28/08/2024
Recruitment status
No longer recruiting
Overall study status
Completed
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
MBT-PP is an intervention for reducing inter-parental conflict. A feasibility study has suggested that MBT-PP shows promise. The current trial aims to establish whether MBT-PP works better at helping parents to reduce their conflict than TAU delivered by local authority staff, and, crucially, whether child outcomes improve as a result of reducing the conflict. The trial also aims to establish the mechanisms by which any positive effects on child outcomes occur.

Who can participate?
Parents of children aged 8-14 years, with have high levels of inter-parental conflict, can be referred to the study by local authority staff in the three participating areas: Bristol, Dorset, and Bournemouth, Christchurch & Poole (BCP).

What does the study involve?
Consenting families will be asked to complete questionnaires prior to being randomly allocated to receive either MBT-PP or TAU. After 16 weeks, during which time, parents will receive their allocated intervention, parents and children will be asked to complete these questionnaires again. After a further 3 months, parents and children will be asked to complete the questionnaires a final time.

What are the possible benefits and risks of participating?
The benefits of participating in this study are that families will receive support for their inter-parental conflict. Although this trial is designed to evaluate MBT-PP, we also expect families to find TAU helpful.
A further benefit is that for every questionnaire completed, the person completing it will receive a voucher to the value of £10, with an additional voucher of the same value at the end of the study (to the value of £40 in total), if they complete all 3 questionnaires.

Possible risks: Completing the outcome measures could raise participants' awareness of any pre-existing distress relating to inter-parental conflict or wellbeing problems. This may cause some temporary distress. Participants will be made aware that they have the right to withdraw from the research and that they do not have to a particular question if they do not want to. Participants will be given signposting information in the participant information sheets for both parents and children in case they feel that they need further help with their mental health or wellbeing at any point.

Families randomised to TAU may be disappointed at not having the opportunity to have MBT-PP. Participants will be made aware of this possibility in the information sheets.

Parents randomised to MBT-PP may experience some distress during the course of therapy, as this is likely to involve addressing distressing issues (conflict with one's co-parent). However, it is expected that MBT-PP will ultimately be beneficial for parents (and children, although they are not directly involved in the therapy) and reduce distress in the long-term. To ensure the best experience for MBT-PP clients, MBT-PP is delivered by MBT-PP practitioners, all of whom are qualified therapists, counsellors, family therapists, or child and adult psychotherapists, accredited and registered with their relevant professional bodies (BACP, UKCP, AFT etc.) and compliant with the requirements of these professional bodies, including ethical standards and professional supervision. Treatment fidelity is supported through fortnightly group supervision, offered by MBT-PP Supervisors who have received additional training. Supervisors attempt to ensure adherence to, and prevent departure from the manualised intervention. This allows Tavistock Relationships to maintain fidelity, clinical oversight, manage risk and develop practitioners' skills further. Supervisors' work, in turn, is overseen by monthly supervision of supervisors, delivered by the most experienced MBT-PP leaders.

Where is the study run from?
Sheffield Hallam University (UK)

When is the study starting and how long is it expected to run for?
June 2022 to March 2025

Who is funding the study?
Youth Endowment Fund (UK)

Who is the main contact?
Dr Abigail Millings, a.millings@shu.ac.uk

Contact information

Dr Abigail Millings
Principal Investigator

Centre for Behavioural Science and Applied Psychology
Sheffield Hallam University
Sheffield
S10 2BQ
United Kingdom

ORCiD logoORCID ID 0000-0002-7849-6048
Phone +44 114 225 2612
Email a.millings@shu.ac.uk

Study information

Study designMulti-centre pragmatic interventional randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Built environment/local authority, Internet/virtual, Other therapist office, School, Other
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet.
Scientific titleEvaluation of Tavistock Relationships MBT-PP to improve child outcomes by reducing inter-parental conflict: a pragmatic efficacy randomised controlled trial with internal pilot
Study acronymSIPCo
Study objectivesCompared to Treatment As Usual (TAU), Mentalising-Based-Therapy for Parents under Pressure (MBT-PP) delivered to parents experiencing high levels of interparental conflict will lead to lower externalising and internalising behaviours in children and young people aged 8-14 at post-intervention.
Ethics approval(s)Approved 10/02/2023, Sheffield Hallam University Research Ethics Committee (Sheffield Hallam University, Howard Street, Sheffield, S1 1WB, UK; +44 (0)114 225 5555; ethicssupport@shu.ac.uk), ref: ER50582599
Health condition(s) or problem(s) studiedChildren's internalising (emotional symptoms and peer problems) and externalising (conduct problems and hyperactivity/inattention) behaviours.
InterventionThe intervention of interest in this trial is Mentalising-Based Therapy for Parents under Pressure (MBT-PP). MBT-PP is a 10-session psychotherapeutic intervention for parents with a high level of inter-parental conflict. MBT-PP is suitable for separated parents or intact couples. The 10 sessions are delivered across 16 weeks and include 2 assessment sessions. The other 8 sessions begin by introducing the skills and behaviours necessary for mentalizing: the capacity to hold others in mind when emotionally aroused and to avoid a swift eruption of conflict. The subsequent sessions build on this ability to think about parents’ own feelings and beliefs, those of their partner, and the needs of their children, ending with a focus on how to maintain the achievements made. MBT-PP is delivered by therapists employed and trained by Tavistock Relationships.

In this trial, MBT-PP will be compared against Treatment As Usual (TAU). TAU comprises support provided by Local Authority staff, using digital resources developed by OnePlusOne, in a guided self-help capacity. That is, local authority staff will provide participants with access to the materials, and support in how to use them, and regular ‘check-ins’. Because both separated and intact couples will be recruited to this trial, two sets of digital resources will be used: Argue Better (AB), which is targeted at couples experiencing conflict, and Getting It Right for Children (GIRFC), which is targeted at separating/separated parents experiencing conflict. Allocation will be commence within each site using an online random number generator, after which, the minimisation program already described will be used.

While it is likely that TAU will also involve other interventions as appropriate (for example a family needing housing advice will receive housing advice), the use of the OPO digital resources in TAU ought to minimise the variation of LA staff practice as it relates to IPC specifically. Training will be provided to attempt to standardise the use and delivery of TAU, but it is noted that this trial is pragmatic in nature, and hence a degree of variation in TAU is anticipated. LA staff will not be asked to withhold any specific forms of support from those allocated to the TAU arm of the trial.
Eligible families will be randomised to receive either MBT-PP or TAU. Because recruitment will be rolling, a minimisation protocol will be implemented within each recruitment site, to ensure balance on the following characteristics: parental relationship status (separated, intact); parent ethnicity (one or both parents of ethnic minority, no parents of ethnic minority); child age group(s) (child[ren] aged 8-11, child[ren] aged 12-14, child[ren] aged both 8-11 & 12-14). Minimisation will be implemented using the MinimPy program.

Parents and children will complete baseline questionnaires before randomisation, at post-intervention, and at follow-up 3 months later.
Intervention typeBehavioural
Primary outcome measureChildren’s internalising and externalising behaviours, measured using the Strengths and Difficulties Questionnaire (Goodman, 1997) ‘total difficulties’ sub-scale, at post-intervention.
Secondary outcome measures1. Children’s internalising and externalising behaviours, measured using the Strengths and Difficulties Questionnaire (Goodman, 1997) ‘total difficulties’ sub-scale, at follow-up.
2. Children’s psychological well-being, measured using the Stirling Children’s Well-being Scale (Liddle & Carter, 2015) at post-intervention and follow up.
3. Parent reports of conflict, measured using an adapted version of the O’Leary-Porter Scale (Porter & O’Leary, 1980), at post-intervention and follow up.
4. Child perception of inter-parental conflict, measured using the Perceptions of Interparental Conflict-Intensity/Frequency Scale (PIC-I/F) (Kline, Wood & Moore, 2003), at post-intervention and follow up.
5. Parent anger, measured using the Dimensions of Anger Reactions- Revised (DAR-R; (Nederlof, Hovens, Muris & Novaco, 2009), at post-intervention and follow up.
6. Parent mentalising capacity, measured using the Parental Reflective Function Questionnaire (Luyten et al., 2009), at post-intervention and follow up.
7. Parenting style, measured using the Parenting Scale Short Form (PS-8) (Kliem et al., 2019), a short form of the Parenting Scale (Arnold et al., 1993,) at post-intervention and follow up.
8. For separated parents only, emotional adaptation to the separation, measured using the Emotional Adaptation to Relationship Dissolution Assessment (Millings et al., 2020), at post-intervention and follow up.
Overall study start date22/06/2022
Completion date31/03/2025

Eligibility

Participant type(s)Mixed
Age groupMixed
Lower age limit8 Years
Upper age limit14 Years
SexBoth
Target number of participants350 families (comprising 700 parents and approximately 700 children) recruited from 3 sites.
Key inclusion criteria1. Parent of child(ren) aged 8-14 years
2. High level of conflict with child(ren)’s other parent
3. Both parents willing to try a supportive intervention to reduce the conflict.
4. One or both parents must score <13 on the DAS-4
5. Referred by local authority staff in one of the 3 participating local authorities (Bristol, Dorset, and Bournemouth, Christchurch & Poole (BCP)).
Key exclusion criteria1. Current issues with substance or alcohol misuse in either parent.
2. Significant mental health diagnosis which is not currently well-managed.
3. Current domestic abuse or violence.
4. Current engagement in care proceedings or private family law proceedings.
Date of first enrolment20/03/2023
Date of final enrolment31/03/2025

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

Bristol City Council
City Hall
College Green
Bristol
BS1 5TR
United Kingdom
Dorset Council
County Hall
Colliton Park
Dorchester
DT1 1XJ
United Kingdom
Bcp Council
Town Hall
Bourne Avenue
Bournemouth
BH2 6DY
United Kingdom

Sponsor information

Sheffield Hallam University
University/education

Centre for Behavioural Science and Applied Psychology
Sheffield
S10 2BQ
England
United Kingdom

Phone +44 114 225 5555
Email ethicssupport@shu.ac.uk
Website http://www.shu.ac.uk/
ROR logo "ROR" https://ror.org/019wt1929

Funders

Funder type

Charity

Youth Endowment Fund

No information available

Results and Publications

Intention to publish date30/06/2026
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryStored in non-publicly available repository
Publication and dissemination planFindings from this trial will be published by the Youth Endowment Fund in the first instance, and in scientific peer-reviewed journals after this.
IPD sharing planThe datasets generated during and/or analysed during the current study will be stored in a non-publicly available repository: the Youth Endowment Fund Archive.

After the end of the study, information about the children of people who have taken part in the study will be shared with the Department for Education (DfE). These data include demographic information (e.g., sex, ethnicity) and Strengths and Difficulties Questionnaire scores. The DfE will replace all identifying information about these children (their name, date of birth, home address) with the children’s unique Pupil Matching Reference number in the DfE’s National Pupil Database. Once this has been done, it is no longer possible to identify any individual child from the study data. This process is called pseudonymisation.

The DfE will transfer the pseudonymised information to the YEF archive, which is stored in the Office for National Statistics’ Secure Research Service. Information in the YEF archive can only be used by approved researchers. Using the unique Pupil Matching Reference numbers added to the data by the Department for Education, it will be possible to link the records held in the YEF archive to other public datasets such as education and criminal justice datasets.

The YEF archive is protected by the Office for National Statistics’ ‘Five Safes’ framework. The information can only be accessed by approved researchers in secure settings and there are strict restrictions about how the information can be used. Data may be used for analyses to explore whether MBT-PP had an impact over a longer period of time for example, whether being part of a project reduces a child’s likelihood of being excluded from school or becoming involved in criminal activity. Data will be kept in the YEF archive indefinitely, with a review occurring every five years to ascertain whether there is continued value in storing the data. Further information about the YEF archive and the Five Safes is available on the YEF’s website: https://youthendowmentfund.org.uk/wp-content/uploads/2021/07/YEF-Data-Guidance-Participants.pdf.

Information on data archiving as described above will be provided to participants via the Participant Information Sheet, and participants will provide consent to participate in the trial on the basis of this understanding.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol file version 3.1 16/05/2024 24/05/2024 No No

Additional files

ISRCTN10266960_Protocol_V3.1_16May2024.pdf

Editorial Notes

28/08/2024: The recruitment end date was changed from 31/08/2024 to 31/03/2025.
24/05/2024: Protocol (not peer reviewed) uploaded.
20/03/2023: Trial's existence confirmed by Sheffield Hallam University Research Ethics Committee