Trial of healthy relationship initiatives for the very early years (THRIVE), evaluating Enhanced Triple P for Baby and Mellow Bumps for those with additional social and care needs during pregnancy and their infants who are at higher risk of maltreatment: Study protocol for a randomised controlled trial

Marion Henderson; Anja Wittkowski; Emma McIntosh; Alex McConnachie; Katie Buston; Philip Wilson; Rachel Calam; Helen Minnis; Lucy Thompson; John O'Dowd; James Law; Elizabeth McGee; Daniel Wight

doi:10.1186/s13063-019-3674-z

Trial of healthy relationship initiatives for the very early years (THRIVE), evaluating Enhanced Triple P for Baby and Mellow Bumps for those with additional social and care needs during pregnancy and their infants who are at higher risk of maltreatment: Study protocol for a randomised controlled trial

Marion Henderson^*, Anja Wittkowski, Emma McIntosh, Alex McConnachie, Katie Buston, Philip Wilson, Rachel Calam, Helen Minnis, Lucy Thompson, John O'Dowd, James Law, Elizabeth McGee, Daniel Wight

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

1 Citation (Scopus)

Abstract

Background: Growing evidence suggests that experiences in the early years play a major role in children’s development in terms of health, wellbeing and educational attainment. The Trial of healthy relationship initiatives for the very
early years (THRIVE) aims to evaluate two antenatal group interventions,
Enhanced Triple P for Baby and Mellow Bumps, designed for those with additional health or social care needs in pregnancy. As both interventions aim to improve maternal mental health and parenting skills, we hypothesise that in the longer term, participation may lead to an improvement in children’s life trajectories.

Methods: THRIVE is a three-arm, longitudinal, randomised controlled trial aiming to recruit 500 pregnant women with additional health or social care needs.
Participants will be referred by health and social care professionals,
predominately midwives. Consenting participants will be block randomised
to one of the three arms: Enhanced Triple P for Baby plus care as usual, Mellow Bumps plus care as usual or care as usual. Groups will commence when participants are between 20 and 34 weeks pregnant.

Discussion: The population we aim to recruit are traditionally referred to as “hard to reach”, therefore we will monitor referrals received from maternity and
social care pathways and will be open to innovation to boost referral
rates. We will set geographically acceptable group locations for
participants, to limit challenges we foresee for group participation and
retention. We anticipate the results of the trial will help inform
policy and practice in supporting women with additional health and
social care needs during antenatal and early postnatal periods. This is
currently a high priority for the Scottish and UK Governments.

Trial registration: International Standard Randomised Controlled Trials Number (ISRCTN) Registry, ISRCTN:21656568. Registered on 28 February 2014 (registered retrospectively (by 3 months)).

Original language	English
Article number	557
Journal	Trials
Volume	20
Issue number	1
DOIs	https://doi.org/10.1186/s13063-019-3674-z
Publication status	Published - 14 Aug 2019

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Henderson, M., Wittkowski, A., McIntosh, E., McConnachie, A., Buston, K., Wilson, P., Calam, R., Minnis, H., Thompson, L., O'Dowd, J., Law, J., McGee, E., & Wight, D. (2019). Trial of healthy relationship initiatives for the very early years (THRIVE), evaluating Enhanced Triple P for Baby and Mellow Bumps for those with additional social and care needs during pregnancy and their infants who are at higher risk of maltreatment: Study protocol for a randomised controlled trial. Trials, 20(1), [557]. https://doi.org/10.1186/s13063-019-3674-z

Trial of healthy relationship initiatives for the very early years (THRIVE), evaluating Enhanced Triple P for Baby and Mellow Bumps for those with additional social and care needs during pregnancy and their infants who are at higher risk of maltreatment : Study protocol for a randomised controlled trial. / Henderson, Marion; Wittkowski, Anja; McIntosh, Emma et al.

In: Trials, Vol. 20, No. 1, 557, 14.08.2019.

Research output: Contribution to journal › Article › peer-review

Henderson, M, Wittkowski, A, McIntosh, E, McConnachie, A, Buston, K, Wilson, P, Calam, R, Minnis, H, Thompson, L, O'Dowd, J, Law, J, McGee, E & Wight, D 2019, 'Trial of healthy relationship initiatives for the very early years (THRIVE), evaluating Enhanced Triple P for Baby and Mellow Bumps for those with additional social and care needs during pregnancy and their infants who are at higher risk of maltreatment: Study protocol for a randomised controlled trial', Trials, vol. 20, no. 1, 557. https://doi.org/10.1186/s13063-019-3674-z

Henderson M, Wittkowski A, McIntosh E, McConnachie A, Buston K, Wilson P et al. Trial of healthy relationship initiatives for the very early years (THRIVE), evaluating Enhanced Triple P for Baby and Mellow Bumps for those with additional social and care needs during pregnancy and their infants who are at higher risk of maltreatment: Study protocol for a randomised controlled trial. Trials. 2019 Aug 14;20(1). 557. https://doi.org/10.1186/s13063-019-3674-z

Henderson, Marion ; Wittkowski, Anja ; McIntosh, Emma et al. / Trial of healthy relationship initiatives for the very early years (THRIVE), evaluating Enhanced Triple P for Baby and Mellow Bumps for those with additional social and care needs during pregnancy and their infants who are at higher risk of maltreatment : Study protocol for a randomised controlled trial. In: Trials. 2019 ; Vol. 20, No. 1.

@article{64d5b297bd6a4a9fac27584f25632f27,

title = "Trial of healthy relationship initiatives for the very early years (THRIVE), evaluating Enhanced Triple P for Baby and Mellow Bumps for those with additional social and care needs during pregnancy and their infants who are at higher risk of maltreatment: Study protocol for a randomised controlled trial",

abstract = "Background: Growing evidence suggests that experiences in the early years play a major role in children{\textquoteright}s development in terms of health, wellbeing and educational attainment. The Trial of healthy relationship initiatives for the very early years (THRIVE) aims to evaluate two antenatal group interventions, Enhanced Triple P for Baby and Mellow Bumps, designed for those with additional health or social care needs in pregnancy. As both interventions aim to improve maternal mental health and parenting skills, we hypothesise that in the longer term, participation may lead to an improvement in children{\textquoteright}s life trajectories. Methods: THRIVE is a three-arm, longitudinal, randomised controlled trial aiming to recruit 500 pregnant women with additional health or social care needs. Participants will be referred by health and social care professionals, predominately midwives. Consenting participants will be block randomised to one of the three arms: Enhanced Triple P for Baby plus care as usual, Mellow Bumps plus care as usual or care as usual. Groups will commence when participants are between 20 and 34 weeks pregnant.Discussion: The population we aim to recruit are traditionally referred to as “hard to reach”, therefore we will monitor referrals received from maternity and social care pathways and will be open to innovation to boost referral rates. We will set geographically acceptable group locations for participants, to limit challenges we foresee for group participation and retention. We anticipate the results of the trial will help inform policy and practice in supporting women with additional health and social care needs during antenatal and early postnatal periods. This is currently a high priority for the Scottish and UK Governments.Trial registration: International Standard Randomised Controlled Trials Number (ISRCTN) Registry, ISRCTN:21656568. Registered on 28 February 2014 (registered retrospectively (by 3 months)).",

author = "Marion Henderson and Anja Wittkowski and Emma McIntosh and Alex McConnachie and Katie Buston and Philip Wilson and Rachel Calam and Helen Minnis and Lucy Thompson and John O'Dowd and James Law and Elizabeth McGee and Daniel Wight",

note = "Funding: THRIVE was funded by the National Institute for Health Research Public Health Research Programme (PHR Project: 11/3002/01). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. Intervention Subvention Funding was provided by the CSO and Scottish Government (GN12KH589 THRIVE). Neither the trial funders nor Sponsor (NHS Greater Glasgow & Clyde Health Board (Reference GN12KH589)) will have any involvement in the implementation of the study design or the analysis of the data. The Sponsor will, however, play an active role in the delivery of the interventions, through employing and managing group facilitators. The Sponsor will also be the grant holder of the subvention funding, granted by the CSO and the Scottish Government to deliver the groups. Approval for all documentation to be used with the trial must be granted by the Sponsor as it will be delivered to NHS patients. Likewise, permission must be sought from the trial funders prior to any public engagement regarding the trial including conference presentations or academic articles. Publisher Copyright: {\textcopyright} 2019 The Author(s). Correction to: Trial of healthy relationship initiatives for the very early years (THRIVE), evaluating Enhanced Triple P for Baby and Mellow Bumps for those with additional social and care needs during pregnancy and their infants who are at higher risk of maltreatment: study protocol for a randomised controlled trial. Marion Henderson, Anja Wittkowski, Emma McIntosh, Alex McConnachie, Katie Buston, Philip Wilson, Rachel Calam, Helen Minnis, Lucy Thompson, John O{\textquoteright}Dowd, James Law, Elizabeth McGee, Daniel Wight & THRIVE Trial Research Team. Trials volume 20, Article number: 557 (2019) Following publication of the original article [1], it has been brought to our attention that an error was slipped into the article's title. Initially published title: Trial of healthy relationship initiatives for the very early years (THRIVE), evaluating Enhanced Triple P for Baby and Mellow Bumps additional social and care needs during pregnancy and their infants who are at higher risk of maltreatment: study protocol for a randomised controlled trial. Corrected title: Trial of healthy relationship initiatives for the very early years (THRIVE), evaluating Enhanced Triple P for Baby and Mellow Bumps for those with additional social and care needs during pregnancy and their infants who are at higher risk of maltreatment: study protocol for a randomised controlled trial.",

year = "2019",

month = aug,

day = "14",

doi = "10.1186/s13063-019-3674-z",

language = "English",

volume = "20",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central",

number = "1",

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TY - JOUR

T1 - Trial of healthy relationship initiatives for the very early years (THRIVE), evaluating Enhanced Triple P for Baby and Mellow Bumps for those with additional social and care needs during pregnancy and their infants who are at higher risk of maltreatment

T2 - Study protocol for a randomised controlled trial

AU - Henderson, Marion

AU - Wittkowski, Anja

AU - McIntosh, Emma

AU - McConnachie, Alex

AU - Buston, Katie

AU - Wilson, Philip

AU - Calam, Rachel

AU - Minnis, Helen

AU - Thompson, Lucy

AU - O'Dowd, John

AU - Law, James

AU - McGee, Elizabeth

AU - Wight, Daniel

N1 - Funding: THRIVE was funded by the National Institute for Health Research Public Health Research Programme (PHR Project: 11/3002/01). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. Intervention Subvention Funding was provided by the CSO and Scottish Government (GN12KH589 THRIVE). Neither the trial funders nor Sponsor (NHS Greater Glasgow & Clyde Health Board (Reference GN12KH589)) will have any involvement in the implementation of the study design or the analysis of the data. The Sponsor will, however, play an active role in the delivery of the interventions, through employing and managing group facilitators. The Sponsor will also be the grant holder of the subvention funding, granted by the CSO and the Scottish Government to deliver the groups. Approval for all documentation to be used with the trial must be granted by the Sponsor as it will be delivered to NHS patients. Likewise, permission must be sought from the trial funders prior to any public engagement regarding the trial including conference presentations or academic articles. Publisher Copyright: © 2019 The Author(s). Correction to: Trial of healthy relationship initiatives for the very early years (THRIVE), evaluating Enhanced Triple P for Baby and Mellow Bumps for those with additional social and care needs during pregnancy and their infants who are at higher risk of maltreatment: study protocol for a randomised controlled trial. Marion Henderson, Anja Wittkowski, Emma McIntosh, Alex McConnachie, Katie Buston, Philip Wilson, Rachel Calam, Helen Minnis, Lucy Thompson, John O’Dowd, James Law, Elizabeth McGee, Daniel Wight & THRIVE Trial Research Team. Trials volume 20, Article number: 557 (2019) Following publication of the original article [1], it has been brought to our attention that an error was slipped into the article's title. Initially published title: Trial of healthy relationship initiatives for the very early years (THRIVE), evaluating Enhanced Triple P for Baby and Mellow Bumps additional social and care needs during pregnancy and their infants who are at higher risk of maltreatment: study protocol for a randomised controlled trial. Corrected title: Trial of healthy relationship initiatives for the very early years (THRIVE), evaluating Enhanced Triple P for Baby and Mellow Bumps for those with additional social and care needs during pregnancy and their infants who are at higher risk of maltreatment: study protocol for a randomised controlled trial.

PY - 2019/8/14

Y1 - 2019/8/14

N2 - Background: Growing evidence suggests that experiences in the early years play a major role in children’s development in terms of health, wellbeing and educational attainment. The Trial of healthy relationship initiatives for the very early years (THRIVE) aims to evaluate two antenatal group interventions, Enhanced Triple P for Baby and Mellow Bumps, designed for those with additional health or social care needs in pregnancy. As both interventions aim to improve maternal mental health and parenting skills, we hypothesise that in the longer term, participation may lead to an improvement in children’s life trajectories. Methods: THRIVE is a three-arm, longitudinal, randomised controlled trial aiming to recruit 500 pregnant women with additional health or social care needs. Participants will be referred by health and social care professionals, predominately midwives. Consenting participants will be block randomised to one of the three arms: Enhanced Triple P for Baby plus care as usual, Mellow Bumps plus care as usual or care as usual. Groups will commence when participants are between 20 and 34 weeks pregnant.Discussion: The population we aim to recruit are traditionally referred to as “hard to reach”, therefore we will monitor referrals received from maternity and social care pathways and will be open to innovation to boost referral rates. We will set geographically acceptable group locations for participants, to limit challenges we foresee for group participation and retention. We anticipate the results of the trial will help inform policy and practice in supporting women with additional health and social care needs during antenatal and early postnatal periods. This is currently a high priority for the Scottish and UK Governments.Trial registration: International Standard Randomised Controlled Trials Number (ISRCTN) Registry, ISRCTN:21656568. Registered on 28 February 2014 (registered retrospectively (by 3 months)).

AB - Background: Growing evidence suggests that experiences in the early years play a major role in children’s development in terms of health, wellbeing and educational attainment. The Trial of healthy relationship initiatives for the very early years (THRIVE) aims to evaluate two antenatal group interventions, Enhanced Triple P for Baby and Mellow Bumps, designed for those with additional health or social care needs in pregnancy. As both interventions aim to improve maternal mental health and parenting skills, we hypothesise that in the longer term, participation may lead to an improvement in children’s life trajectories. Methods: THRIVE is a three-arm, longitudinal, randomised controlled trial aiming to recruit 500 pregnant women with additional health or social care needs. Participants will be referred by health and social care professionals, predominately midwives. Consenting participants will be block randomised to one of the three arms: Enhanced Triple P for Baby plus care as usual, Mellow Bumps plus care as usual or care as usual. Groups will commence when participants are between 20 and 34 weeks pregnant.Discussion: The population we aim to recruit are traditionally referred to as “hard to reach”, therefore we will monitor referrals received from maternity and social care pathways and will be open to innovation to boost referral rates. We will set geographically acceptable group locations for participants, to limit challenges we foresee for group participation and retention. We anticipate the results of the trial will help inform policy and practice in supporting women with additional health and social care needs during antenatal and early postnatal periods. This is currently a high priority for the Scottish and UK Governments.Trial registration: International Standard Randomised Controlled Trials Number (ISRCTN) Registry, ISRCTN:21656568. Registered on 28 February 2014 (registered retrospectively (by 3 months)).

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U2 - 10.1186/s13063-019-3674-z

DO - 10.1186/s13063-019-3674-z

M3 - Article

C2 - 31506097

AN - SCOPUS:85072013239

VL - 20

JO - Trials

JF - Trials

SN - 1745-6215

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Abstract

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