Dataset Information

Enhancing maternal and infant wellbeing: study protocol for a feasibility trial of the Baby Triple P Positive Parenting programme for mothers with severe mental health difficulties (the IMAGINE study).

ABSTRACT:

Background

There is a strong evidence base for the benefits of parenting interventions for parents without severe mental illness (SMI). As the impact of maternal SMI can be significant on child development, mothers need support to maximise outcomes for themselves and their children. Some mothers with SMI require admission jointly with their baby to a Mother and Baby Unit (MBU), a psychiatric inpatient ward, for assessment and treatment. However, MBUs do not yet offer formally evaluated, evidence-based parenting interventions as a matter of routine. This paper describes a study to investigate the feasibility and acceptability of conducting a randomised controlled trial (RCT) to evaluate a parenting and psychological intervention targeting the mother's and infant's wellbeing for mothers admitted to a MBU.

Methods/design

This study is a multisite, single-blind feasibility trial with half the participants randomised to the Baby Triple P Positive Parenting Programme plus treatment as usual (TAU) and the other half randomised to TAU alone. Self-report and observer-rated assessments are collected at baseline, 10 weeks post-baseline and 6 months post-baseline. Participants are mothers admitted to a MBU in the Northwest of England or the Midlands. Participants are included if they are fluent in English to provide informed, written consent. Our objective is to determine whether we can recruit 66 women, randomise 60, and retain them in the intervention and study, and whether the intervention and study procedures are acceptable. As part of a nested process evaluation, qualitative interview data from trial participants and MBU staff will inform feasibility and acceptability. The feasibility of collecting data required to conduct an economic evaluation of the intervention will also be explored.

Discussion

Although research has been conducted in relation to mothers with severe mental illness and MBUs, to our knowledge, this is the first controlled trial to test the feasibility, acceptability, uptake and retention alongside the potential efficacy of a parenting intervention for this population. This study is essential to examine the contextual challenges involved in this setting with this population and to identify any refinements required.

Trial registration

ISRCTN12765736 . Date of first registration: 2 February 2017.

SUBMITTER: Wittkowski A

PROVIDER: S-EPMC6131761 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Enhancing maternal and infant wellbeing: study protocol for a feasibility trial of the Baby Triple P Positive Parenting programme for mothers with severe mental health difficulties (the IMAGINE study).

Wittkowski Anja A Cartwright Kim K Emsley Richard R Bee Penny P Calam Rachel R Cross Catherine C Abel Kathryn M KM Reid Holly H

Trials 20180910 1

<h4>Background</h4>There is a strong evidence base for the benefits of parenting interventions for parents without severe mental illness (SMI). As the impact of maternal SMI can be significant on child development, mothers need support to maximise outcomes for themselves and their children. Some mothers with SMI require admission jointly with their baby to a Mother and Baby Unit (MBU), a psychiatric inpatient ward, for assessment and treatment. However, MBUs do not yet offer formally evaluated, ...[more]

PMID: 30201040

Similar Datasets

Project description:BackgroundModels of infectious disease are increasingly utilising empirical contact data to quantify the number of potentially infectious contacts between age groups. While a growing body of data is being collected on contact patterns across many populations, less attention has been paid to the social contacts of young infants. We collected information on the social contacts of primary carers of young infants and investigated their potential for use as a proxy for contacts made by their infant.MethodsWe recruited primary carers of infants under one year of age residing in two geographically, demographically and socioeconomically distinct local government areas of Melbourne, Australia - Boroondara and Hume - including a sub-group of Turkish-speaking participants. Participants recorded their own contacts in a paper diary and noted whether their infant was present or absent. Information collected included times at an address; description of location; and details on people contacted at the location. Descriptive summary measures and distributions of contacts by location type, intensity, day of contact and by age are reported.ResultsOf the 226 participants recruited, 220 completed diaries were returned. Participant contact patterns were similar across all groups, with respect to the types of locations, intensity and day of contact, with some variation in the number of unique daily contacts. The infant was present at around 85% of locations at which the primary carer contacted other individuals. The majority of contacts occurring when the infant was present were in Own Home (32%), Retail and Hospitality (18%) and Transport (18%) settings. The mean daily number of unique contacts by infants was estimated as 9.1, 8.7 and 6.5 in Boroondara, Hume (English) and Hume (Turkish), respectively, with a similar age distribution across each of our surveyed groups.ConclusionsOur demonstration that contact patterns of mothers with infants are reasonably robust to socioeconomic and cultural differences is a step forward in modelling infectious disease transmission. With infants spending most of their time in the company of their mother, contact patterns of mothers are a useful proxy measure of infant contact patterns. The age distribution of contacts made by infants estimated in this study may be used to supplement population-wide contact information commonly used in infectious disease transmission models.

Project description:BACKGROUND:Specialist parenting intervention could improve coexistent parenting and child mental health difficulties of parents affected by severe personality difficulties. OBJECTIVE:Conduct a feasibility trial of Helping Families Programme-Modified (HFP-M), a specialist parenting intervention. DESIGN:Pragmatic, mixed-methods trial, 1:1 random allocation, assessing feasibility, intervention acceptability and outcome estimates. SETTINGS:Two National Health Service health trusts and local authority children's social care. PARTICIPANTS:Parents: (i) primary caregiver, (ii) 18 to 65 years, (iii) severe personality difficulties, (iv) proficient English and (v) capacity for consent. Child: (i) 3 to 11 years, (ii) living with index parent and (iii) significant emotional/behavioural difficulties. INTERVENTION:HFP-M: 16-session home-based intervention using parenting and therapeutic engagement strategies. Usual care: standard care augmented by single psychoeducational parenting session. OUTCOMES:Primary feasibility outcome: participant retention rate. SECONDARY OUTCOMES:(i) rates of recruitment, eligibility and data completion, and (ii) rates of intervention acceptance, completion and alliance (Working Alliance Inventory-Short Revised). Primary clinical outcome: child behaviour (Eyberg Child Behaviour Inventory). SECONDARY OUTCOMES:child mental health (Concerns About My Child, Child Behaviour Checklist-Internalising Scale), parenting (Arnold-O'Leary Parenting Scale, Kansas Parental Satisfaction Scale) and parent mental health (Symptom-Checklist-27). Quantitative data were collected blind to allocation. RESULTS:Findings broadly supported non-diagnostic selection criterion. Of 48 participants recruited, 32 completed post-intervention measures at mean 42 weeks later. Participant retention exceeded a priori rate (HFP-M=18; Usual care=14; 66.7%, 95%?CI 51.6% to 79.6%). HFP-M was acceptable, with delivery longer than planned. Usual care had lower alliance rating. Child and parenting outcome effects detected across trial arms with potential HFP-M advantage (effect size range: 0.0 to 1.3). CONCLUSION:HFP-M is an acceptable and potentially effective specialist parenting intervention. A definitive trial is feasible, subject to consideration of recruitment and retention methods, intervention efficiency and comparator condition. Caution is required in interpretation of results due to reduced sample size. No serious adverse events reported. TRIAL REGISTRATION NUMBER:ISRCTN14573230.

Project description:Problems in infant mental health such as the ability to experience, regulate, and express emotional states is expressed in behavioral problems like excessive crying, feeding, and sleeping problems. Parenting programs are popular but their effectiveness on infant mental health remains uncertain. Possibly, because recent studies have focused only on parental and parent-child measures while they miss to assess infant behavioral measures. The goal of this pilot study is to fill in this gap by assessing infantile behavioral measures. We investigated the acceptance and first indicators of efficacy of the universal group parenting training Baby Triple P (BTP) compared to a care as usual (CAU) control condition focusing on early behavioral problems. In all, 49 couples were randomly allocated to receive either eight BTP sessions before birth and per telephone after birth or to take part in CAU. Infant behavior was assessed with a diary and a structured diagnostic interview. Parental self-report measures of partnership quality and parental competence were assessed before birth, 10 weeks after birth and at 6-month follow-up. Since the parent training was conducted before the birth of the child, the child's mental health could not be assessed before the parent training. Thus, for this variable no within measurement (pre-post) could be carried out and intention-to-treat analysis was not possible. However, a between group analysis comparing BTP against CAU took place to assess effectiveness of BTP on children's mental health. Mothers and fathers rated the program as feasible and relevant. Results indicate significant group differences in crying behavior 6 months after birth to the benefit of the intervention group. No beneficial outcomes were found for feeding and sleeping problems in infants or partnership quality, parental sense of competence in parents. Due to an unrepresentative high level of education of the participating parents and the small sample size, these findings can be considered preliminary. Nevertheless, these results allow to further investigate the effectivity of BTP in large-scale clinical trials. Behavioral diaries or diagnostic interviews for early mental health problems should be routinely implemented in randomized controlled trials (RCTs) in order not to miss possible behavioral changes in infants. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT02313493.

Dataset Information

Enhancing maternal and infant wellbeing: study protocol for a feasibility trial of the Baby Triple P Positive Parenting programme for mothers with severe mental health difficulties (the IMAGINE study).

Background

Methods/design

Discussion

Trial registration

Publications

Enhancing maternal and infant wellbeing: study protocol for a feasibility trial of the Baby Triple P Positive Parenting programme for mothers with severe mental health difficulties (the IMAGINE study).

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets