Dataset Information

Community-based parent-delivered early detection and intervention programme for infants at high risk of cerebral palsy in a low-resource country (Learning through Everyday Activities with Parents (LEAP-CP): protocol for a randomised controlled trial.

ABSTRACT:

Introduction

Cerebral palsy (CP) is the most common childhood physical disability, with 80% estimated to be in low-middle-income countries. This study aims to (1) determine the accuracy of General Movements (GMs)/Hammersmith Infant Neurological Examination (HINE) for detecting CP at 18 months corrected age (CA); (2) determine the effectiveness of a community-based parent-delivered early intervention for infants at high risk of CP in West Bengal, India (Learning through Everyday Activities with Parents for infants with CP; LEAP-CP).

Methods

This study comprises two substudies: (1) a study of the predictive validity of the GMs and HINE for detecting CP; (2) randomised, double-blinded controlled trial of a novel intervention delivered through peer trainers (Community Disability Workers, CDW) compared with health advice (15 fortnightly visits). 142 infants at high risk of CP ('absent fidgety' GMs; 'high risk score' on HINE) aged 12-40 weeks CA will be recruited to the intervention substudy, with infants randomised based on a computer-generated sequence. Researchers will be masked to group allocation, and caregivers and CDWs naïve to intervention status. Visits will include therapeutic modules (goal-directed active motor/cognitive strategies and LEAP-CP games) and parent education. Health advice is based on the Integrated Management of Childhood Illness, WHO. Infants will be evaluated at baseline, post intervention and 18 months CA. The primary hypothesis is that infants receiving LEAP-CP will have greater scaled scores on the Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (mobility domain) at 18 months compared with health advice. Secondary outcomes include infant functional motor, cognitive, visual and communication development; infant growth; maternal mental health.

Ethics and dissemination

This study is approved through appropriate Australian and Indian ethics committees (see in text) with families providing written informed consent. Findings from this trial will be disseminated through peer-reviewed journal publications and conference presentations.

Trial registration number

12616000653460p; Pre-results.

SUBMITTER: Benfer KA

PROVIDER: S-EPMC6020941 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Community-based parent-delivered early detection and intervention programme for infants at high risk of cerebral palsy in a low-resource country (Learning through Everyday Activities with Parents (LEAP-CP): protocol for a randomised controlled trial.

Benfer Katherine A KA Novak Iona I Morgan Catherine C Whittingham Koa K Khan Naila Zaman NZ Ware Robert S RS Bell Kristie L KL Bandaranayake Sasaka S Salt Alison A Ghosh Asis Kumar AK Bhattacharya Anjan A Samanta Sandip S Moula Golam G Bose Dilip D Tripathi Santanu S Boyd Roslyn N RN

BMJ open 20180622 6

<h4>Introduction</h4>Cerebral palsy (CP) is the most common childhood physical disability, with 80% estimated to be in low-middle-income countries. This study aims to (1) determine the accuracy of General Movements (GMs)/Hammersmith Infant Neurological Examination (HINE) for detecting CP at 18 months corrected age (CA); (2) determine the effectiveness of a community-based parent-delivered early intervention for infants at high risk of CP in West Bengal, India (Learning through Everyday Activitie ...[more]

PMID: 29934387

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Project description:IntroductionCerebral 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 analysisThis 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 sizetotal 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 disseminationEthics 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 numberACTRN12619000969167p.

Project description:Mobile and wearable sensors provide a unique opportunity to capture the daily activities and interactions that shape developmental trajectories, with potential to revolutionize the study of development (de Barbaro, 2019). However, developmental research employing sensors is still in its infancy, and parents' comfort using these devices is uncertain. This exploratory report assesses parent willingness to participate in sensor studies via a nationally representative survey (N = 210) and live recruitment of a low-income, minority population for an ongoing study (N = 359). The survey allowed us to assess how protocol design influences acceptability, including various options for devices and datastream resolution, conditions of data sharing, and feedback. By contrast, our recruitment data provided insight into parents' true willingness to participate in a sensor study, with a protocol including 72 h of continuous audio, motion, and physiological data. Our results indicate that parents are relatively conservative when considering participation in sensing studies. However, nearly 41 % of surveyed parents reported that they would be at least somewhat willing to participate in studies with audio or video recordings, 26 % were willing or extremely willing, and 14 % reported being extremely willing. These results roughly paralleled our recruitment results, where 58 % of parents indicated interest, 29 % of parents scheduled to participate, and 10 % ultimately participated. Additionally, 70 % of caregivers stated their reason for not participating in the study was due to barriers unrelated to sensing while about 25 % noted barriers due to either privacy concerns or the physical sensors themselves. Parents' willingness to collect sensitive datastreams increased if data stayed within the household for individual use only, are shared anonymously with researchers, or if parents receive feedback from devices. Overall, our findings suggest that given the correct circumstances, mobile sensors are a feasible and promising tool for characterizing children's daily interactions and their role in development.

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Project description:ObjectiveTo evaluate a worksite based parenting programme-Talking Parents, Healthy Teens-designed to help parents learn to address sexual health with their adolescent children.DesignRandomised controlled trial (April 2002-December 2005).Setting13 worksites in southern California.Participants569 parents completed baseline surveys at work, gave permission for confidential surveys to be posted to their adolescent children, and were randomised to intervention or control groups. Parents and adolescents completed follow-up surveys at one week, three months, and nine months after the programme.InterventionTalking Parents, Healthy Teens consists of eight weekly one hour sessions at worksites for parents of adolescent children in 6th-10th grade (about ages 11-16 years).Main outcome measuresParent-adolescent communication about a list of sexual topics; whether parent taught adolescent how to use a condom; ability to communicate with parent/adolescent about sex; openness of parent-adolescent communication about sex.ResultsDifferences between intervention and control groups were significant for the mean number of new sexual topics that parents and adolescents reported discussing between baseline and each follow-up (P<0.001 for each); intervention parents were less likely than controls to discuss no new topics (8% v 29%, 95% confidence interval for difference 16% to 24%) and more likely to discuss seven or more new topics (38% v 8%, 19% to 41%) at nine months. Some differences increased after completion of the programme: at one week after the programme, 18% of adolescents in the intervention group and 3% in the control group (6% to 30%) said that their parents had reviewed how to use a condom since baseline (P<0.001); this grew to 29% v 5% (13% to 36%) at nine months (P<0.001). Compared with controls at nine months, parents and adolescents in the intervention group reported greater ability to communicate with each other about sex (P<0.001) and more openness in communication about sex (P<0.001).ConclusionsA worksite based programme can have substantial effects on communication between parents and adolescents about sexual health.Trial registrationClinical Trials NCT00465010.

Dataset Information

Community-based parent-delivered early detection and intervention programme for infants at high risk of cerebral palsy in a low-resource country (Learning through Everyday Activities with Parents (LEAP-CP): protocol for a randomised controlled trial.

Introduction

Methods

Ethics and dissemination

Trial registration number

Publications

Community-based parent-delivered early detection and intervention programme for infants at high risk of cerebral palsy in a low-resource country (Learning through Everyday Activities with Parents (LEAP-CP): protocol for a randomised controlled trial.

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