A feasibility study of Baby Triple P Positive Parenting Programme for mothers with mental health difficulties

• Register: ISRCTN
• Last refreshed on: 20 June 2022
• Main ID: ISRCTN12765736
• Date of registration: 02/02/2017
• Prospective Registration: No
• Primary sponsor: University of Manchester
• Public title: A feasibility study of Baby Triple P Positive Parenting Programme for mothers with mental health difficulties
• Scientific title: Enhancing maternal and infant wellbeing: A feasibility study of the Baby Triple P Positive Parenting Programme for mothers with severe mental health difficulties
• Date of first enrolment: 28/11/2016
• Target sample size: 75
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN12765736
• Study type: Interventional
• Study design: Randomised; Both; Design type: Treatment, Prevention, Psychological & Behavioural, Complex Intervention, Qualitative (Treatment)
• Phase: Not Applicable

Countries of recruitment

England, United Kingdom

Contacts

• Name: Kim Cartwright

Key inclusion & exclusion criteria

Inclusion criteria:
Patient participants:
1. Aged 18 years or more
2. Have at least one infant aged birth to 12 months who they care for or are going to care for
3. Are in the third trimester of pregnancy and are expected to reside on the MBU following delivery
4. Are able to comprehend and understand English to provide consent to the study
5. Are able to provide written informed consent. Note: MBU staff routinely assesses their capacity

Staff participants:
1. Permanent full-time or part-time members of the Mother and Baby Unit (MBU) staff team
2. Have worked on the MBU for at least six months
3. Proficient in English to understand the study, provide written, informed consent and can take part in interviews

Exclusion criteria:
Patient participants:
1. Participants who do not have a sufficiently good working knowledge of English to provide written informed consent and understand and complete questionnaires. Use of interpreters is beyond the scope of this feasibility study, but could be built into a definitive trial. Note: If interpreters are involved in the routine care of a participant, then their inclusion can be considered.
2. Participants whose current symptoms seriously compromise their ability to concentrate on the assessments or intervention sessions. Examples include participants who experience persistent and loud auditory hallucinations that they clearly react to. Eligibility can be reassessed once a participant’s acute symptoms subside.
3. Participants who show severe personality disorder traits including significant current self-harming behaviours (such as attempting suicide). Note: MBU staff assess these behaviours as part of routine practice alongside risk issues.
4. Participants whose infant will be removed from their care on a non-temporary basis
5. Participants whose discharge has been scheduled within 7 days from date of recruitment

Staff participants:
1. Nursing students or bank staff who work on the MBU on a temporary basis only.
2. Have less than six months experience of working on the MBU.


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Specialty: Mental Health, Primary sub-specialty: Psychosis; UKCRC code/ Disease: Mental Health/ Schizophrenia, schizotypal and delusional disorders
Mental and Behavioural Disorders
Maternal mental health difficulties

Intervention(s)

Participants are randomised via a clinical trials unit telephone service using an allocation ratio of 1:1 and permuted blocks of size 4 and 6 to one of two groups.

Intervention group: Participants receive the Baby Triple P Positive Parenting Programme (Baby Triple P) plus treatment as usual (TAU). Baby Triple P consists of eight sessions (estimated to be delivered over 8-10 weeks) of which the first four sessions are delivered face-to-face on an individual basis. These sessions are designed to enhance the knowledge, skills and confidence of parents. Sessions cover advice on parenting, bonding and mother-baby-interaction and relationship, partner and family support and brief psychological coping strategies. The subsequent four sessions are designed to be delivered over the telephone, which is suitable for an inpatient setting when the women may be discharged or on home leave from the unit in preparation for discharge. The telephone sessions allow the participant to review progress and practice skills, thereby enhancing her parenting confidence/competence and overall wellbeing. The intervention has a flexible delivery format, which is suitable for mothers with severe mental health difficulties who care for babies.

Control group: Participants receive treatment as usual (TAU) only.

TAU, in line with all standard and individually prescribed clinical interventions as directed by the MBU clinical teams, will apply for both the intervention and control group. This will include case management using a care programme approach (CPA) from their allocated Mother and Baby Unit (MBU) psychiatric nurse, pharmacological interventions from psychiatry (where indicated) and non-parenting, brief psychological interventions

Primary Outcome(s)

Maternal confidence and competence is measured using the Maternal Efficacy Questionnaire at baseline and 8-10 weeks and 6 months post-baseline.

Secondary Outcome(s)

Self-Report Outcomes (completed by participants):
1. Maternal mood is measured using the Brief Depression Anxiety and Stress Scale at baseline and 8-10 weeks and 6 months
2. Mother-infant relationship is measured using the Postpartum Bonding Questionnaire at baseline and 8-10 weeks and 6 months
3. Quality of life is measured using the EQ-5D-5L at baseline and 8-10 weeks and 6 months
4. Mental illness symptom severity and distress is measured using the Brief Symptom Scale at baseline and 8-10 weeks and 6 months

Observer-Rated Outcomes (completed by MBU staff):
1. Mental illness symptoms are measured using the Brief Psychiatric Rating Scale at baseline and 8-10 weeks and 6 months
2. Mental illness symptom improvement from admission (to the MBU) to discharge is measured using the Clinical Global Impression Scales at baseline and 8-10 weeks and 6 months
4. Infant wellbeing is measured using the Louis Mother and Child Risk Observation (Louis MACRO) at baseline and 8-10 weeks and 6 months
5. Health outcomes are measured using Health of the Nation Outcome Scales (HoNOs) at baseline and 8-10 weeks and 6 months

Feasibility and Acceptability Outcomes:
1. Feasibility of recruitment will be measured through recording how participants found out about the study, recruitment rates, number of potential participants found eligible, initially approached by Mother and Baby Unit (MBU) staff, consented to be approached by the research team, and approached about the study by the research team, reasons for declining to be approached or take take part in the study if known and percentage of eligible participants consented and their characteristics
2. Feasibility of randomisation will be assessed by recording number of refusals to be randomised
3. Engagement/retention in the study and to study procedures will be measured by recording the number of participants who withdraw and the time point at which they withdraw from the study. Reasons for leaving the study early will be recorded if known. The number of participants who complete outcome measures at each of the time points and the completeness of their data will be recorded.
4. Engagement/retention in the interventino will be measured by recording the percentage of intervention sessions delivered, duration and maternal self-reports of time spent between sessions on Baby Triple P as well as maternal use of the workbooks. Reasons for leaving the intervention early will be recorded if known.
5. Acceptability of the intervention and study design and procedures will be assessed post-intervention via a questionnaire (for acceptability of the intervention only) and semi-structured interviews with participants allocated to receive Baby Triple P plus Treatment as Usual (n > 15) and Mother and Baby Unit staff (n = 15).

Secondary ID(s)

31813

Source(s) of Monetary Support

National Institute for Health Research

Ethics review

Status:
Approval date:
Contact:

North West - Greater Manchester South Research Ethics Committee, 26/09/2016, ref: 16/NW/0510

Results

• Results available: Yes
• Date Completed: 16/04/2019