Study protocol: Peer delivered early intervention (Learning through Everyday Activities with Parents for Infants at risk of Cerebral Palsy: LEAP-CP) for First Nation Australian infants at high risk of cerebral palsy - An RCT study

Katherine Benfer; Roslyn N. Boyd; Yvette Roe; Ruth Fagan; Carly Luke; Leeann Mick-Ramsamy; Koa Whittingham; Iona Novak; Margot Bosanquet; Lynda McNamara; Gulam Khandaker; Lucy Fogarty; Yvonne Cadet-James; Alan Ruben; Tracy Comans; Anthony Smith; Robert S. Ware

doi:10.1136/bmjopen-2021-059531

Study protocol: Peer delivered early intervention (Learning through Everyday Activities with Parents for Infants at risk of Cerebral Palsy: LEAP-CP) for First Nation Australian infants at high risk of cerebral palsy - An RCT study

Katherine Benfer, Roslyn N. Boyd, Yvette Roe, Ruth Fagan, Carly Luke, Leeann Mick-Ramsamy, Koa Whittingham, Iona Novak, Margot Bosanquet, Lynda McNamara, Gulam Khandaker, Lucy Fogarty, Yvonne Cadet-James, Alan Ruben, Tracy Comans, Anthony Smith, Robert S. Ware

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Abstract

Introduction Cerebral palsy (CP) is the most common childhood physical disability with rates approximately 50% higher in First Nations Australian children. This study aims to evaluate a culturally-adapted parent-delivered early intervention programme for First Nations Australian infants at high risk of CP (Learning through Everyday Activities with Parents for infants with CP; LEAP-CP). Methods and analysis This study is a randomised assessor masked controlled trial. Infants with birth/postnatal risk factors will be eligible for screening. Infants at high risk of CP ( absent fidgety' on General Movements Assessment, and/or suboptimal score' on the Hammersmith Infant Neurological Examination) aged 12-52 weeks corrected age will be recruited. Infants and their caregivers will be randomised to receive LEAP-CP (intervention) or health advice (comparator). LEAP-CP is a culturally-adapted programme of 30 home visits delivered by a peer trainer (First Nations Community Health Worker); and includes goal-directed active motor/cognitive strategies, CP learning games and caregiver educational modules. The control arm receives a monthly health advice visit, based on the Key Family Practices, WHO. All infants continue to receive standard (mainstream) Care as Usual. Dual child primary outcomes are Peabody Developmental Motor Scales-2 (PDMS-2) and Bayley Scales of Infant Development-III. The primary caregiver outcome is the Depression, Anxiety and Stress Scale. Secondary outcomes include function, goal attainment, vision, nutritional status and emotional availability. Sample size: total of 86 children (43/group) will enable an effect size of 0.65 on the PDMS-2 to be detected (80% power, α=0.05; 10% attrition). Ethics and dissemination Ethics approval through Queensland ethics committees and Aboriginal Controlled Community Health Organisation Research Governance Groups, with families providing written informed consent. Findings will be disseminated with guidance from the Participatory Action Research, in collaboration with First Nations communities; peer-reviewed journal publications and national/international conference presentations. Trial registration number ACTRN12619000969167p.

Original language	English
Article number	e059531
Pages (from-to)	1-16
Number of pages	16
Journal	BMJ Open
Volume	13
Issue number	3
DOIs	https://doi.org/10.1136/bmjopen-2021-059531
Publication status	Published - 13 Mar 2023

Bibliographical note

Funding Information:
This work was supported by a National Health and Medical Research Council-European Union Collaborative Research Grant (APP1194128); Cerebral Palsy Alliance Project Grants (PG14017 and PG05318); Children’s Hospital Foundation Project Grant (50276_2018); Perpetual Impact Grant (IPAP2020/0808); Tropical Australian Academic Health Centre Seed Funding (2020); NHMRC Early Career Fellowship (KB, APP1145212), NHMRC Fellowship (RB, NHMRC115038); NHMRC Centre for Research Excellence (Australasian Cerebral Palsy Clinical Trials Network NHMRC1116442).

Funding Information:
The authors would like to acknowledge the invaluable contributions of the implementing partner organisations for the LEAP-CP trial. Specifically, the teams at Apunipima Cape York Health Council, Gurriny Yealamucka Health Service, Gidgee Healing, Kaurareg Aboriginal Land Trust, Cairns and Hinterland Hospital and Health Service, Townsville Hospital and Health Service, Central Queensland Hospital and Health Service, North West Hospital and Health Service, Mackay Hospital and Health Service, Queensland Children’s Hospital and other partners yet to connect. We would also like to acknowledge the Born ToGetThere Consortium for their collaboration on the project (EU Horizon grant H2020-410574988, NHMRC 1194128). We acknowledge the contribution of Professor Paul Colditz in his role as Data Safety Monitor. Finally, we would like to acknowledge the support of the Queensland Cerebral Palsy and Rehabilitation Research Centre clinical research team (Ms Sarah Gibson, Ms Bernadette Shannon, Ms Kym Morris, Ms Christine Finn, Ms Ellena Oakes) for their clinical inputs and role as advanced General Movements raters.

Publisher Copyright:
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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Benfer, K., Boyd, R. N., Roe, Y., Fagan, R., Luke, C., Mick-Ramsamy, L., Whittingham, K., Novak, I., Bosanquet, M., McNamara, L., Khandaker, G., Fogarty, L., Cadet-James, Y., Ruben, A., Comans, T., Smith, A., & Ware, R. S. (2023). Study protocol: Peer delivered early intervention (Learning through Everyday Activities with Parents for Infants at risk of Cerebral Palsy: LEAP-CP) for First Nation Australian infants at high risk of cerebral palsy - An RCT study. BMJ Open, 13(3), 1-16. Article e059531. https://doi.org/10.1136/bmjopen-2021-059531

@article{9fdcf3ba19e44d7aa45acade45ee4b12,

title = "Study protocol: Peer delivered early intervention (Learning through Everyday Activities with Parents for Infants at risk of Cerebral Palsy: LEAP-CP) for First Nation Australian infants at high risk of cerebral palsy - An RCT study",

abstract = "Introduction Cerebral palsy (CP) is the most common childhood physical disability with rates approximately 50% higher in First Nations Australian children. This study aims to evaluate a culturally-adapted parent-delivered early intervention programme for First Nations Australian infants at high risk of CP (Learning through Everyday Activities with Parents for infants with CP; LEAP-CP). Methods and analysis This study is a randomised assessor masked controlled trial. Infants with birth/postnatal risk factors will be eligible for screening. Infants at high risk of CP ( absent fidgety' on General Movements Assessment, and/or suboptimal score' on the Hammersmith Infant Neurological Examination) aged 12-52 weeks corrected age will be recruited. Infants and their caregivers will be randomised to receive LEAP-CP (intervention) or health advice (comparator). LEAP-CP is a culturally-adapted programme of 30 home visits delivered by a peer trainer (First Nations Community Health Worker); and includes goal-directed active motor/cognitive strategies, CP learning games and caregiver educational modules. The control arm receives a monthly health advice visit, based on the Key Family Practices, WHO. All infants continue to receive standard (mainstream) Care as Usual. Dual child primary outcomes are Peabody Developmental Motor Scales-2 (PDMS-2) and Bayley Scales of Infant Development-III. The primary caregiver outcome is the Depression, Anxiety and Stress Scale. Secondary outcomes include function, goal attainment, vision, nutritional status and emotional availability. Sample size: total of 86 children (43/group) will enable an effect size of 0.65 on the PDMS-2 to be detected (80% power, α=0.05; 10% attrition). Ethics and dissemination Ethics approval through Queensland ethics committees and Aboriginal Controlled Community Health Organisation Research Governance Groups, with families providing written informed consent. Findings will be disseminated with guidance from the Participatory Action Research, in collaboration with First Nations communities; peer-reviewed journal publications and national/international conference presentations. Trial registration number ACTRN12619000969167p.",

keywords = "Developmental neurology & neurodisability, Paediatric neurology, REHABILITATION MEDICINE",

author = "Katherine Benfer and Boyd, {Roslyn N.} and Yvette Roe and Ruth Fagan and Carly Luke and Leeann Mick-Ramsamy and Koa Whittingham and Iona Novak and Margot Bosanquet and Lynda McNamara and Gulam Khandaker and Lucy Fogarty and Yvonne Cadet-James and Alan Ruben and Tracy Comans and Anthony Smith and Ware, {Robert S.}",

note = "Funding Information: This work was supported by a National Health and Medical Research Council-European Union Collaborative Research Grant (APP1194128); Cerebral Palsy Alliance Project Grants (PG14017 and PG05318); Children{\textquoteright}s Hospital Foundation Project Grant (50276_2018); Perpetual Impact Grant (IPAP2020/0808); Tropical Australian Academic Health Centre Seed Funding (2020); NHMRC Early Career Fellowship (KB, APP1145212), NHMRC Fellowship (RB, NHMRC115038); NHMRC Centre for Research Excellence (Australasian Cerebral Palsy Clinical Trials Network NHMRC1116442). Funding Information: The authors would like to acknowledge the invaluable contributions of the implementing partner organisations for the LEAP-CP trial. Specifically, the teams at Apunipima Cape York Health Council, Gurriny Yealamucka Health Service, Gidgee Healing, Kaurareg Aboriginal Land Trust, Cairns and Hinterland Hospital and Health Service, Townsville Hospital and Health Service, Central Queensland Hospital and Health Service, North West Hospital and Health Service, Mackay Hospital and Health Service, Queensland Children{\textquoteright}s Hospital and other partners yet to connect. We would also like to acknowledge the Born ToGetThere Consortium for their collaboration on the project (EU Horizon grant H2020-410574988, NHMRC 1194128). We acknowledge the contribution of Professor Paul Colditz in his role as Data Safety Monitor. Finally, we would like to acknowledge the support of the Queensland Cerebral Palsy and Rehabilitation Research Centre clinical research team (Ms Sarah Gibson, Ms Bernadette Shannon, Ms Kym Morris, Ms Christine Finn, Ms Ellena Oakes) for their clinical inputs and role as advanced General Movements raters. Publisher Copyright: {\textcopyright} Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.",

year = "2023",

month = mar,

day = "13",

doi = "10.1136/bmjopen-2021-059531",

language = "English",

volume = "13",

pages = "1--16",

journal = "BMJ Open",

issn = "2044-6055",

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Benfer, K, Boyd, RN, Roe, Y, Fagan, R, Luke, C, Mick-Ramsamy, L, Whittingham, K, Novak, I, Bosanquet, M, McNamara, L, Khandaker, G, Fogarty, L, Cadet-James, Y, Ruben, A, Comans, T, Smith, A & Ware, RS 2023, 'Study protocol: Peer delivered early intervention (Learning through Everyday Activities with Parents for Infants at risk of Cerebral Palsy: LEAP-CP) for First Nation Australian infants at high risk of cerebral palsy - An RCT study', BMJ Open, vol. 13, no. 3, e059531, pp. 1-16. https://doi.org/10.1136/bmjopen-2021-059531

Study protocol: Peer delivered early intervention (Learning through Everyday Activities with Parents for Infants at risk of Cerebral Palsy: LEAP-CP) for First Nation Australian infants at high risk of cerebral palsy - An RCT study. / Benfer, Katherine; Boyd, Roslyn N.; Roe, Yvette et al.
In: BMJ Open, Vol. 13, No. 3, e059531, 13.03.2023, p. 1-16.

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

TY - JOUR

T1 - Study protocol

T2 - Peer delivered early intervention (Learning through Everyday Activities with Parents for Infants at risk of Cerebral Palsy: LEAP-CP) for First Nation Australian infants at high risk of cerebral palsy - An RCT study

AU - Benfer, Katherine

AU - Boyd, Roslyn N.

AU - Roe, Yvette

AU - Fagan, Ruth

AU - Luke, Carly

AU - Mick-Ramsamy, Leeann

AU - Whittingham, Koa

AU - Novak, Iona

AU - Bosanquet, Margot

AU - McNamara, Lynda

AU - Khandaker, Gulam

AU - Fogarty, Lucy

AU - Cadet-James, Yvonne

AU - Ruben, Alan

AU - Comans, Tracy

AU - Smith, Anthony

AU - Ware, Robert S.

N1 - Funding Information: This work was supported by a National Health and Medical Research Council-European Union Collaborative Research Grant (APP1194128); Cerebral Palsy Alliance Project Grants (PG14017 and PG05318); Children’s Hospital Foundation Project Grant (50276_2018); Perpetual Impact Grant (IPAP2020/0808); Tropical Australian Academic Health Centre Seed Funding (2020); NHMRC Early Career Fellowship (KB, APP1145212), NHMRC Fellowship (RB, NHMRC115038); NHMRC Centre for Research Excellence (Australasian Cerebral Palsy Clinical Trials Network NHMRC1116442). Funding Information: The authors would like to acknowledge the invaluable contributions of the implementing partner organisations for the LEAP-CP trial. Specifically, the teams at Apunipima Cape York Health Council, Gurriny Yealamucka Health Service, Gidgee Healing, Kaurareg Aboriginal Land Trust, Cairns and Hinterland Hospital and Health Service, Townsville Hospital and Health Service, Central Queensland Hospital and Health Service, North West Hospital and Health Service, Mackay Hospital and Health Service, Queensland Children’s Hospital and other partners yet to connect. We would also like to acknowledge the Born ToGetThere Consortium for their collaboration on the project (EU Horizon grant H2020-410574988, NHMRC 1194128). We acknowledge the contribution of Professor Paul Colditz in his role as Data Safety Monitor. Finally, we would like to acknowledge the support of the Queensland Cerebral Palsy and Rehabilitation Research Centre clinical research team (Ms Sarah Gibson, Ms Bernadette Shannon, Ms Kym Morris, Ms Christine Finn, Ms Ellena Oakes) for their clinical inputs and role as advanced General Movements raters. Publisher Copyright: © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2023/3/13

Y1 - 2023/3/13

N2 - Introduction Cerebral palsy (CP) is the most common childhood physical disability with rates approximately 50% higher in First Nations Australian children. This study aims to evaluate a culturally-adapted parent-delivered early intervention programme for First Nations Australian infants at high risk of CP (Learning through Everyday Activities with Parents for infants with CP; LEAP-CP). Methods and analysis This study is a randomised assessor masked controlled trial. Infants with birth/postnatal risk factors will be eligible for screening. Infants at high risk of CP ( absent fidgety' on General Movements Assessment, and/or suboptimal score' on the Hammersmith Infant Neurological Examination) aged 12-52 weeks corrected age will be recruited. Infants and their caregivers will be randomised to receive LEAP-CP (intervention) or health advice (comparator). LEAP-CP is a culturally-adapted programme of 30 home visits delivered by a peer trainer (First Nations Community Health Worker); and includes goal-directed active motor/cognitive strategies, CP learning games and caregiver educational modules. The control arm receives a monthly health advice visit, based on the Key Family Practices, WHO. All infants continue to receive standard (mainstream) Care as Usual. Dual child primary outcomes are Peabody Developmental Motor Scales-2 (PDMS-2) and Bayley Scales of Infant Development-III. The primary caregiver outcome is the Depression, Anxiety and Stress Scale. Secondary outcomes include function, goal attainment, vision, nutritional status and emotional availability. Sample size: total of 86 children (43/group) will enable an effect size of 0.65 on the PDMS-2 to be detected (80% power, α=0.05; 10% attrition). Ethics and dissemination Ethics approval through Queensland ethics committees and Aboriginal Controlled Community Health Organisation Research Governance Groups, with families providing written informed consent. Findings will be disseminated with guidance from the Participatory Action Research, in collaboration with First Nations communities; peer-reviewed journal publications and national/international conference presentations. Trial registration number ACTRN12619000969167p.

AB - Introduction Cerebral palsy (CP) is the most common childhood physical disability with rates approximately 50% higher in First Nations Australian children. This study aims to evaluate a culturally-adapted parent-delivered early intervention programme for First Nations Australian infants at high risk of CP (Learning through Everyday Activities with Parents for infants with CP; LEAP-CP). Methods and analysis This study is a randomised assessor masked controlled trial. Infants with birth/postnatal risk factors will be eligible for screening. Infants at high risk of CP ( absent fidgety' on General Movements Assessment, and/or suboptimal score' on the Hammersmith Infant Neurological Examination) aged 12-52 weeks corrected age will be recruited. Infants and their caregivers will be randomised to receive LEAP-CP (intervention) or health advice (comparator). LEAP-CP is a culturally-adapted programme of 30 home visits delivered by a peer trainer (First Nations Community Health Worker); and includes goal-directed active motor/cognitive strategies, CP learning games and caregiver educational modules. The control arm receives a monthly health advice visit, based on the Key Family Practices, WHO. All infants continue to receive standard (mainstream) Care as Usual. Dual child primary outcomes are Peabody Developmental Motor Scales-2 (PDMS-2) and Bayley Scales of Infant Development-III. The primary caregiver outcome is the Depression, Anxiety and Stress Scale. Secondary outcomes include function, goal attainment, vision, nutritional status and emotional availability. Sample size: total of 86 children (43/group) will enable an effect size of 0.65 on the PDMS-2 to be detected (80% power, α=0.05; 10% attrition). Ethics and dissemination Ethics approval through Queensland ethics committees and Aboriginal Controlled Community Health Organisation Research Governance Groups, with families providing written informed consent. Findings will be disseminated with guidance from the Participatory Action Research, in collaboration with First Nations communities; peer-reviewed journal publications and national/international conference presentations. Trial registration number ACTRN12619000969167p.

KW - Developmental neurology & neurodisability

KW - Paediatric neurology

KW - REHABILITATION MEDICINE

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U2 - 10.1136/bmjopen-2021-059531

DO - 10.1136/bmjopen-2021-059531

M3 - Article

C2 - 36914182

AN - SCOPUS:85150132324

SN - 2044-6055

VL - 13

SP - 1

EP - 16

JO - BMJ Open

JF - BMJ Open

IS - 3

M1 - e059531

ER -

Benfer K, Boyd RN, Roe Y, Fagan R, Luke C, Mick-Ramsamy L et al. Study protocol: Peer delivered early intervention (Learning through Everyday Activities with Parents for Infants at risk of Cerebral Palsy: LEAP-CP) for First Nation Australian infants at high risk of cerebral palsy - An RCT study. BMJ Open. 2023 Mar 13;13(3):1-16. e059531. doi: 10.1136/bmjopen-2021-059531

Study protocol: Peer delivered early intervention (Learning through Everyday Activities with Parents for Infants at risk of Cerebral Palsy: LEAP-CP) for First Nation Australian infants at high risk of cerebral palsy - An RCT study

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