A Feasibility Randomized Controlled Trial of a Parenting Intervention Offered to Women With Severe Mental Health Problems and Delivered in a Mother and Baby Unit Setting: The IMAgINE Study Outcomes

TY - JOUR

T1 - A Feasibility Randomized Controlled Trial of a Parenting Intervention Offered to Women With Severe Mental Health Problems and Delivered in a Mother and Baby Unit Setting

T2 - The IMAgINE Study Outcomes

AU - Wittkowski, Anja

AU - Emsley, Richard

AU - Bee, Penny E.

AU - Camacho, Elizabeth

AU - Calam, Rachel

AU - Abel, Kathryn M.

AU - Duxbury, Paula

AU - Gomez, Paula

AU - Cartwright, Kim

AU - Reid, Holly E.

N1 - Funding Information: This trial was supported by the NIHR Research for Patient Benefit Programme (NIHR RfPB, grant number PB-PG-1014-3505) and sponsored by The University of Manchester. Study approvals were granted by the NHS National Research Ethics Service (NRES) via the Northwest–Greater Manchester South Research Ethics Committee (REC) (16/NW/0510), the Health Research Authority (HRA) (IRAS project number 188486, protocol number 16233) and the Research and Innovation departments of both NHS trusts overseeing the two participating MBUs (Greater Manchester Mental Health NHS Foundation Trust and Birmingham and Solihull Mental Health NHS Foundation Trust). Furthermore, an independent Trial Steering and Data Monitoring Committee and a Patient and Public Involvement (PPI) group supported this study through regular meetings throughout the feasibility trial's duration. Funding Information: This trial was supported by the NIHR Research for Patient Benefit Programme (NIHR RfPB, grant number PB-PG-1014-3505) and sponsored by the University of Manchester. Study approvals were granted by the NHS National Research Ethics Service (NRES) via the Northwest–Greater Manchester South Research Ethics Committee (REC) (16/NW/0510), the Health Research Authority (HRA) (IRAS project number 188486, protocol number 16233) and the Research and Innovation departments of both NHS trusts overseeing the two participating MBUs (e.g., Greater Manchester Mental Health NHS Foundation Trust and Birmingham and Solihull Mental Health NHS Foundation Trust). The patients/participants provided their written informed consent to participate in this study. Funding Information: We would like to express our sincere gratitude and thanks to the women who took part in this study and our service user reference group whose ideas and suggestions we valued highly and who offered us their ongoing support and advice throughout the study. We are also grateful for the support offered by Brigid Corrigan and Catherine Cross from GMMH and to collaborators at BSMH, namely Claire Hooper, Mary McGuinness, Giles Berrisford and Linda Everard. Thank you also to Rangeni Zinyama, Nadia Starkova and Blair Davis from BSMH and to Grace Bamber from GMMH for supporting the data collection. Finally, we greatly appreciated the support from the Manchester CTU and in particular Tracey Rose as well as various members of our Trial Steering Committee, chaired by Andrew Gumley, as well as the assistance offered by Gokce Cokamay Yilmaz and Zoyah Sheikh from GMMH's Perinatal Mental Health and Parenting (PRIME) Research Unit in finalizing this manuscript. Funding Information: This feasibility trial represents independent research, which was funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (PB-PG-1014-35059). The work was also supported by the Greater Manchester Mental Health NHS Foundation Trust (GMMH) and the Birmingham and Solihull Mental Health NHS Foundation Trust (BSMH). The Open Access publication was made possible by the support of the University of Manchester. RE is supported by the NIHR Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King's College London and an NIHR Research Professorship (NIHR300051). Publisher Copyright: Copyright © 2022 Wittkowski, Emsley, Bee, Camacho, Calam, Abel, Duxbury, Gomez, Cartwright and Reid.

PY - 2022/5/16

Y1 - 2022/5/16

N2 - Background: Approximately 1–2% of mothers may experience severe mental illness (SMI) requiring admission to an inpatient Mother and Baby Unit (MBU). MBUs aim to provide mental health assessment and treatment and strengthen the mother-infant relationship, essential for infant development. Whilst MBUs offer various interventions, they do not routinely offer structured parenting interventions. The Baby Triple P Positive Parenting Program (BTP) was developed to enhance parenting competence, psychological coping and the quality of partner and other social support. Guided by lived experience consultation, we aimed to determine the feasibility and acceptability of delivering BTP plus Treatment as Usual (TAU) in this setting. Method: A multi-site, parallel-group, single-blind pilot randomized controlled trial (registration: ISRCTN12765736) comparing BTP+TAU to TAU in participants, recruited from two MBUs in England. The Baby Triple P intervention consisted of eight parenting sessions, with the final four being delivered over the telephone following MBU discharge. Feasibility outcomes were participant intervention engagement and study retention. Clinical outcomes including maternal parenting competence, bonding and mental health outcomes were assessed at baseline, post-baseline/intervention (10 weeks) and six-month follow-up. Data were analyzed using descriptive statistics and linear regression models. An economic feasibility analysis was also conducted. Results: Thirty-seven of the 67 eligible participants consented; 34 were randomized (16 to BTP+TAU and 18 to TAU), of whom 20 were retained at post-intervention data collection and 21 at six-month follow-up. Twelve participants (75%) completed the intervention, which was rated as highly acceptable. Clinical outcomes signaled potential improvements in maternal parenting competence, bonding, mood and mental health symptomatology in participants who received the intervention. Healthcare resource use and EQ-5D-5L questionnaires were well-completed by participants. Delivering BTP in this setting is estimated to cost £443-822 per participant. Conclusions: This is the first trial of a parenting intervention in a MBU setting. BTP is feasible and acceptable to mothers with SMI, with a promising signal for treatment efficacy. Although minor modifications may be required for the collection of observer-rated measures post-MBU discharge, the findings indicate that a larger, definitive trial could be conducted, especially if the setting is extended to include perinatal mental health community settings.

AB - Background: Approximately 1–2% of mothers may experience severe mental illness (SMI) requiring admission to an inpatient Mother and Baby Unit (MBU). MBUs aim to provide mental health assessment and treatment and strengthen the mother-infant relationship, essential for infant development. Whilst MBUs offer various interventions, they do not routinely offer structured parenting interventions. The Baby Triple P Positive Parenting Program (BTP) was developed to enhance parenting competence, psychological coping and the quality of partner and other social support. Guided by lived experience consultation, we aimed to determine the feasibility and acceptability of delivering BTP plus Treatment as Usual (TAU) in this setting. Method: A multi-site, parallel-group, single-blind pilot randomized controlled trial (registration: ISRCTN12765736) comparing BTP+TAU to TAU in participants, recruited from two MBUs in England. The Baby Triple P intervention consisted of eight parenting sessions, with the final four being delivered over the telephone following MBU discharge. Feasibility outcomes were participant intervention engagement and study retention. Clinical outcomes including maternal parenting competence, bonding and mental health outcomes were assessed at baseline, post-baseline/intervention (10 weeks) and six-month follow-up. Data were analyzed using descriptive statistics and linear regression models. An economic feasibility analysis was also conducted. Results: Thirty-seven of the 67 eligible participants consented; 34 were randomized (16 to BTP+TAU and 18 to TAU), of whom 20 were retained at post-intervention data collection and 21 at six-month follow-up. Twelve participants (75%) completed the intervention, which was rated as highly acceptable. Clinical outcomes signaled potential improvements in maternal parenting competence, bonding, mood and mental health symptomatology in participants who received the intervention. Healthcare resource use and EQ-5D-5L questionnaires were well-completed by participants. Delivering BTP in this setting is estimated to cost £443-822 per participant. Conclusions: This is the first trial of a parenting intervention in a MBU setting. BTP is feasible and acceptable to mothers with SMI, with a promising signal for treatment efficacy. Although minor modifications may be required for the collection of observer-rated measures post-MBU discharge, the findings indicate that a larger, definitive trial could be conducted, especially if the setting is extended to include perinatal mental health community settings.

KW - feasibility and acceptability

KW - inpatient admission

KW - intervention

KW - mothers

KW - parenting

KW - perinatal

KW - severe mental illness (SMI)

UR - http://www.scopus.com/inward/record.url?scp=85131428132&partnerID=8YFLogxK

U2 - 10.3389/fpsyt.2022.815018

DO - 10.3389/fpsyt.2022.815018

M3 - Article

AN - SCOPUS:85131428132

SN - 1664-0640

VL - 13

JO - Frontiers in Psychiatry

JF - Frontiers in Psychiatry

M1 - 815018

ER -