Supporting Parenting at Home-Empowering Rehabilitation through Engagement (SPHERE): study protocol for a randomised control trial.
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ABSTRACT: Introduction
Infants with neurodevelopmental disabilities (NDs) show emotional, cognitive and sociointeractive dysregulation dramatically impacting on caregiving behaviour. Early video-feedback interventions (VFIs) are effective in promoting sensitive parenting, which in turn supports infants' development, even in case of ND. In the light of limited resources of the healthcare systems, technological advances in telemedicine may facilitate the delivery of VFI to a greater number of families of infants with ND. To date, no study has implemented a telemedicine VFI (TVFI) for families of infants diagnosed with ND.Methods and analysis
The Supporting Parenting at Home-Empowering Rehabilitation through Engagement project is a randomised controlled trial aimed at assessing the effectiveness of an early family-centred TVFI parenting support on dyads with infants diagnosed with ND. It includes two arms (TVFI vs Booklet Psychoeducational Intervention) and three assessment phases: T0, baseline; T1, immediate postintervention; T2, 6-month follow-up.Ethics and dissemination
This study is funded by the Italian Ministry of Health and was approved by the Ethics Committee (Pavia). Results will be published in peer-reviewed journals and presented at national and international scientific conferences.Trial registration number
The study protocol has been also registered on NIH Clinical Trials (protocol code NCT04656483; Pre-results).
SUBMITTER: Grumi S
PROVIDER: S-EPMC8672000 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:AimTo investigate the short- and long-term effects of home-based pulmonary rehabilitation (HBPR) on functional capacity, quality of life, peripheral muscle strength, dyspnoea and daily physical activity in people with bronchiectasis.MethodsRandomised controlled trial with 63 participants with bronchiectasis. The HBPR group performed three sessions per week for 8 weeks (aerobic exercise: step training for 20 min; resistance training: exercises for quadriceps, hamstrings, deltoids and biceps brachii using elastic bands). The control group received a recommendation to walk at moderate intensity, three times per week. A weekly phone call was conducted for all participants, and the HBPR group received a home visit every 15 days. The primary outcome was distance in the incremental shuttle walk test (ISWT). Secondary outcomes were time in the endurance shuttle walk test (ESWT), number of steps in the incremental step test, quality of life, quadriceps muscle strength and daily physical activity. Measures were taken before and after intervention and 6 months later.ResultsAfter the intervention, the HBPR group had increased ISWT distance compared with the control group with between-group difference 87.9 m (95% CI 32.4-143.5 m). In addition, between-group differences were found in the ESWT, incremental step test, quality of life and quadriceps muscle strength, favouring the HBPR group. After 6 months, no differences were observed between the groups.ConclusionHBPR is an effective alternative offering of pulmonary rehabilitation for people with bronchiectasis. However, the programme was not effective in maintaining the benefits after 6 months of follow-up.
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Project description:BackgroundPulmonary rehabilitation is a cornerstone of care for COPD but uptake of traditional centre-based programmes is poor. We assessed whether home-based pulmonary rehabilitation, delivered using minimal resources, had equivalent outcomes to centre-based pulmonary rehabilitation.MethodsA randomised controlled equivalence trial with 12 months follow-up. Participants with stable COPD were randomly assigned to receive 8 weeks of pulmonary rehabilitation by either the standard outpatient centre-based model, or a new home-based model including one home visit and seven once-weekly telephone calls from a physiotherapist. The primary outcome was change in 6 min walk distance (6MWD).ResultsWe enrolled 166 participants to receive centre-based rehabilitation (n=86) or home-based rehabilitation (n=80). Intention-to-treat analysis confirmed non-inferiority of home-based rehabilitation for 6MWD at end-rehabilitation and the confidence interval (CI) did not rule out superiority (mean difference favouring home group 18.6 m, 95% CI -3.3 to 40.7). At 12 months the CI did not exclude inferiority (-5.1 m, -29.2 to 18.9). Between-group differences for dyspnoea-related quality of life did not rule out superiority of home-based rehabilitation at programme completion (1.6 points, -0.3 to 3.5) and groups were equivalent at 12 months (0.05 points, -2.0 to 2.1). The per-protocol analysis showed the same pattern of findings. Neither group maintained postrehabilitation gains at 12 months.ConclusionsThis home-based pulmonary rehabilitation model, delivered with minimal resources, produced short-term clinical outcomes that were equivalent to centre-based pulmonary rehabilitation. Neither model was effective in maintaining gains at 12 months. Home-based pulmonary rehabilitation could be considered for people with COPD who cannot access centre-based pulmonary rehabilitation.Trial registration numberNCT01423227, clinicaltrials.gov.
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Project description:Children displaying psychosocial problems are at an increased risk of negative developmental outcomes. Parenting practices are closely linked with child development and behaviour, and parenting programmes have been recommended in the treatment of child psychosocial problems. However, parental mental health also needs to be addressed when delivering parenting programmes as it is linked with parenting practices, child outcomes, and treatment outcomes of parenting programmes. This paper describes the protocol of a study examining the effects of a combined intervention of a parenting programme and a cognitive behavioural intervention for mental health problems.The effects of a combined intervention of Triple P Discussion Groups and Stress Control will be examined using a randomised controlled trial design. Parents with a child aged 3-8 years will be recruited to take part in the study. After obtaining informed consent and pre-intervention measures, participants will be randomly assigned to either an intervention or a waitlist condition. The two primary outcomes for this study are change in dysfunctional/ineffective parenting practices and change in symptoms of depression, anxiety, and stress. Secondary outcomes are child behaviour problems, parenting experiences, parental self-efficacy, family relationships, and positive parental mental health. Demographic information, participant satisfaction with the intervention, and treatment fidelity data will also be collected. Data will be collected at pre-intervention, mid-intervention, post-intervention, and 3-month follow-up.The aim of this paper is to describe the study protocol of a randomised controlled trial evaluating the effects of a combined intervention of Triple P Discussion Groups and Stress Control in comparison to a waitlist condition. This study is important because it will provide evidence about the effects of this combined intervention for parents with 3-8 year old children. The results of the study could be used to inform policy about parenting support and support for parents with mental health problems.ClinicalTrial.gov: NCT01777724, UTN: U1111-1137-1053.
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