scholarly journals Early intervention for children at risk of visual processing dysfunctions from 1 year of age: a randomized controlled trial protocol

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Marlou J. G. Kooiker ◽  
Yoni van der Linden ◽  
Jenneke van Dijk ◽  
Ymie J. van der Zee ◽  
Renate M. C. Swarte ◽  
...  
Keyword(s):  
At Risk ◽  
Randomized Controlled Trial ◽  
Visual Processing ◽  
Intervention Program ◽  
Controlled Trial ◽  
Clinical Care ◽  
Control Group ◽  
Randomized Controlled ◽  
Extremely Preterm ◽  
Intervention Protocol

Abstract Background An increasing number of children are suffering from brain damage-related visual processing dysfunctions (VPD). There is currently a lack of evidence-based intervention methods that can be used early in development. We developed a visual intervention protocol suitable from 1 year of age. The protocol is structured, comprehensive and individually adaptive, and is paired with quantitative outcome assessments. Our aim is to investigate the effectiveness of this first visual intervention program for young children with (a risk of) VPD. Methods This is a single-blind, placebo-controlled trial that is embedded within standard clinical care. The study population consists of 100 children born very or extremely preterm (< 30 weeks) at 1 year of corrected age (CA), of whom 50% are expected to have VPD. First, children undergo a visual screening at 1 year CA. If they are classified as being at risk of VPD, they are referred to standard care, which involves an ophthalmic and visual function assessment and a (newly developed) visual intervention program. This program consists of a general protocol (standardized and similar for all children) and a supplement protocol (adapted to the specific needs of the child). Children are randomly allocated to an intervention group (starting upon inclusion at 1 year CA) or a control group (postponed: starting at 2 years CA). The control group will receive a placebo treatment. The effectiveness of early visual intervention will be examined with follow-up visual and neurocognitive assessments after 1 year (upon completion of the direct intervention) and after 2 years (upon completion of the postponed intervention). Discussion Through this randomized controlled trial we will establish the effectiveness of a new and early visual intervention program. Combining a general and supplement protocol enables both structured comparisons between participants and groups, and custom habilitation that is tailored to a child’s specific needs. The design ensures that all included children will benefit from participation by advancing the age at which they start receiving an intervention. We expect results to be applicable to the overall population of children with (a risk of) VPD early in life. Trial registration Netherlands Trial Register: NTR6952. Registered 19 January 2018.

scholarly journals Early intervention for children at risk of visual processing dysfunctions from 1 year of age: a Randomized Controlled Trial protocol

2019 ◽  
Author(s):  
Marlou Kooiker ◽  
Yoni van der Linden ◽  
Jenneke van Dijk ◽  
Ymie J van der Zee ◽  
Renate MC Swarte ◽  
...  
Keyword(s):  
At Risk ◽  
Visual Processing ◽  
Intervention Program ◽  
Controlled Trial ◽  
Clinical Care ◽  
Intervention Group ◽  
Placebo Treatment ◽  
Control Group ◽  
Extremely Preterm ◽  
Intervention Protocol

Abstract Background An increasing amount of children suffer from brain damage-related visual processing dysfunctions (VPD). At present, there is a lack of evidence-based intervention methods that can be used early in development. We developed a visual intervention protocol suitable from 1 year of age. The protocol is structured, comprehensive and individually-adaptive and is paired with quantitative outcome assessments. Our aim is to investigate effectiveness of this first visual intervention program for young children with (a risk of) VPD. Methods We conduct a single-blind, placebo-controlled trial that is embedded within standard clinical care. The study population consists of 100 children born very or extremely preterm (<30 weeks) of 1 year of corrected age (CA), of whom 50% are expected to have VPD. First, children undergo a visual screening at 1 year CA. If they are classified as being at risk of VPD, they are referred to standard care: an ophthalmic and visual function assessment and a (newly developed) visual intervention program. This program consist of a general protocol (standardized and similar for all children) and a supplement protocol (adapted to specific needs of the child).. Children are randomly allocated to an intervention group (starting upon inclusion at 1 year CA), or a control group (postponed: starting at 2 years CA). The control group will receive a placebo treatment. The effectiveness of early visual intervention will be examined with follow-up visual and neurocognitive assessments after 1 year (upon completion of the direct intervention) and after 2 years (upon completion of the postponed intervention). Discussion Through this RCT we will establish the effectiveness of a new and early visual intervention program. Combining a general and supplement protocol enables both structured comparisons between participants and groups, and custom habilitation that is tailored to the children’s specific needs. The design ensures that all included children will benefit from participation by advancing the age at which they start receiving an intervention. We expect results to be applicable to the overall population of children with (a risk of) VPD early in life.

scholarly journals A Non-Randomized Controlled Trial for the Effectiveness of the ‘Aibo’ Intervention Program for Distraction in Childhood Vaccination

2021 ◽  
Author(s):  
Kyoko Tanaka ◽  
Maoko Hayakawa ◽  
Chihiro Noda ◽  
Moemi Nakamura ◽  
Akio Nakamura ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Intervention Program ◽  
Controlled Trial ◽  
Intervention Group ◽  
Behavioral Observation ◽  
Childhood Vaccination ◽  
Control Group ◽  
Randomized Controlled ◽  
Study Results ◽  
Face Scale

Abstract Procedures and actions such as injections and immobilization cause pain and distress to children. In the pediatric field, there is a need for interventions and support to alleviate the pain and distress caused by such medical procedures. In recent years, the introduction of robots as a means of distraction has begun to be attempted. In this study, we conducted a non-randomized controlled trial to examine the effect of intervention using ‘aibo’, a dog-like robot which has artificial intelligence (AI), to promote distraction in children after vaccination. As a result, 57 children (32 in the intervention group) participated in the study. Results of a t-test with the control group showed that the intervention group using aibo had significantly less pain following the post-vaccination intervention than the control group using stuffed dog (Face Scale, t(55) = 2.582, p = .0125; Behavioral Observation Scale, t(55) = 2.772, p = .00759). The results support the hypothesis that the aibo intervention group will be less distressed and able to calm down more quickly after vaccination than the control group. Conclusion : AI-powered aibo interventions that allow for interactive interaction can be an effective distraction method during painful procedures such as vaccinations.

scholarly journals Do home pregnancy tests bring women to community health workers for antenatal care counselling? A randomized controlled trial in Madagascar

2019 ◽  
Vol 34 (8) ◽  
pp. 566-573
Author(s):  
Alison B Comfort ◽  
Randall C Juras ◽  
Sarah E K Bradley ◽  
Justin Ranjalahy Rasolofomanana ◽  
Anja Noeliarivelo Ranjalahy ◽  
...  
Keyword(s):  
At Risk ◽  
Randomized Controlled Trial ◽  
Reproductive Health ◽  
Health Services ◽  
Antenatal Care ◽  
Health Workers ◽  
Controlled Trial ◽  
Control Group ◽  
Reproductive Health Services ◽  
Randomized Controlled

Abstract Task-shifting the provision of pregnancy tests to community health workers (CHWs) in low-resource settings has the potential to reach significantly more underserved women at risk of pregnancy with essential reproductive health services. This study assessed whether an intervention to supply CHWs with home pregnancy tests brought more clients for antenatal care (ANC) counselling. We implemented a randomized controlled trial among CHWs providing reproductive health services to women in Eastern Madagascar. We used ordinary least squares regressions to estimate the effect of the intervention, with district- and month-fixed effects and CHW baseline characteristics as control variables. Our outcomes of interest included whether the intervention increased: (1) the number of women at risk of pregnancy who sought services from CHWs; (2) the number of these women who knew they were pregnant by the end of visit; and (3) the number of these women who received ANC counselling during visit. We found that providing pregnancy tests to CHWs to distribute to their clients for free significantly increased the number of women at risk of pregnancy who sought services from CHWs. At follow-up, treatment-group CHWs provided services to 6.3 clients compared with 4.2 clients among control-group CHWs, which represents a 50% relative increase from the control-group mean. A significantly higher number of these clients knew they were pregnant by the end of the visit, with a mean of 0.95 in treatment compared with 0.10 in control (Coeff. 0.86; 95% CI 0.59–1.13). A significantly higher number of these clients received antenatal counselling at the visit (Coeff. 0.4; 95% CI 0.14–0.64). Introducing free home pregnancy tests as part of community-based health services can improve pregnancy care by attracting more clients at risk of pregnancy to services at the community level, enabling more women to confirm they are pregnant and receive antenatal counselling.

scholarly journals A RANDOMIZED CONTROLLED TRIAL ON THE ISLAMIC-BASED PROGRAM USING FAMILY APPROACHES IN PREVENTING ADOLESCENTS’ SMOKING BEHAVIOR IN INDONESIA: A STUDY PROTOCOL

2020 ◽  
Vol 6 (4) ◽  
pp. 136-140
Author(s):  
Fithria Fithria ◽  
Muhammad Adlim ◽  
Syarifah Rauzatul Jannah ◽  
Teuku Tahlil
Keyword(s):  
Randomized Controlled Trial ◽  
Study Protocol ◽  
Intervention Program ◽  
Controlled Trial ◽  
Smoking Behavior ◽  
Smoking Prevention ◽  
Control Group ◽  
Clinical Trial Registry ◽  
Randomized Controlled ◽  
Family Approach

Background: Smoking is a significant problem especially among Indonesian adolescents. A number of smoking prevention programs have been developed and implemented, but most of them do not work significantly for the Indonesian adolescents who are mostly Muslim.Objective: The aim of this article is to outline a study protocol for measuring the effects of Islamic-based program using family approaches on the prevention of adolescents’ smoking behavior.Methods: The study will use a cluster randomized controlled trial conducted in three junior high schools, in Aceh Province, Indonesia. A total of 150 students will be involved in this study, where each school will be represented by 50 students. Each school group will be given the respective treatments. The first group will receive health-based intervention program, the second group will receive Islamic-based intervention program, and the last group will act as a control group receiving no intervention. The outcomes include the knowledge about smoking, attitudes toward smoking, smoking intention and smoking behavior of the adolescents. All outcomes will be measured using validated questionnaires.Discussion: If the Islamic-based intervention using family approach is effective, then this approach could be implemented not only in Indonesia but also in other countries with the same social characteristics.Trial registration: Australian New Zealand Clinical Trial Registry, ACTRN 12620000465954

scholarly journals Effect of a parent-provided early intervention program on infant health and development: a randomized controlled trial

2018 ◽  
Vol 5 (3) ◽  
pp. 695
Author(s):  
Basavaraj K. ◽  
Sireesha S. ◽  
Suresh J.
Keyword(s):  
Randomized Controlled Trial ◽  
Early Intervention ◽  
Problem Solving ◽  
Intervention Program ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Early Intervention Program ◽  
Problem Solving Skills ◽  
Randomized Controlled

Background: Early Intervention Program (EIP) is a unique way of providing ideal stimulation, education and care for children. EIP are designed to provide detection, treatment, prevention of handicaps, developmental delays, and environmental deprivation as early in a child's life as possible. Objective of present study were to assess the effect of parent-provided EIP on infant cognitive, psychomotor and socio- emotional behaviors at the completion of age 12 months and to evaluate whether these effects were moderated by the infant feeding practices, general health status and socio-demographic characters.Methods: The present study was randomized controlled trial conducted at villages under Vantamuri PHC area attached to J.N Medical College, Belgaum during the period May 2012 to August 2013, with a sample size of 64, full term, normal babies and weighing ≥2.5 kg. At the end of 12 months, babies were assessed by an independent evaluator using BSID-II and ASQ/SE questionnaire.Results: In the present study the mental index (MDI) scores were higher in intervention group than control group (106.63 Vs 94.45, P=0.0001). Problem solving skills were higher in intervention group compared to control group (21.33 Vs 11.56, P=0.000). Person social skills were higher for intervention compared to control (27.66 Vs 22.34, P=0.001). Children with fewer episodes of diarrhea and acute respiratory infections showed better performance.Conclusions: Early Intervention Program effectively increases the cognitive, person social, problem solving and socio-emotional skills at 12 months of age.

scholarly journals Early rehabilitation for children with visual processing dysfunctions from 1 year of age: a Randomized Controlled Trial protocol

2019 ◽  
Author(s):  
Marlou Kooiker ◽  
Yoni van der Linden ◽  
Jenneke van Dijk ◽  
Ymie J van der Zee ◽  
Renate MC Swarte ◽  
...  
Keyword(s):  
Visual Processing ◽  
Controlled Trial ◽  
Clinical Care ◽  
Intervention Group ◽  
Visual Outcome ◽  
Placebo Treatment ◽  
Rehabilitation Program ◽  
Control Group ◽  
Visual Rehabilitation ◽  
Extremely Preterm

Abstract Background An increasing amount of children suffer from brain damage-related visual processing dysfunctions (VPD). At present, there is a lack of evidence-based rehabilitation methods that can be used early in development. We developed a visual rehabilitation protocol suitable from 1 year of age. The protocol contains objective, quantitative outcomes and is structured, comprehensive and individually-adaptive. Our aim is to investigate effectiveness of this first visual rehabilitation program for young children with (a risk of) VPD. Methods We conduct a single-blind, placebo-controlled trial that is embedded within standard clinical care. The study population consists of 100 children born very or extremely preterm (<30 weeks) of 1 year of corrected age (CA), of whom 50% are expected to have VPD. First, children undergo a visual screening at 1 year CA. If they are classified as being at risk of VPD, they are referred to standard care: an ophthalmic and visual function assessment and a (newly developed) visual rehabilitation program. This program consist of a general protocol (standardized and similar for all children) and a supplement protocol (adapted to specific needs of the child), and employs quantitative parameters of visual outcome. Children are randomly allocated to an intervention group (starting upon inclusion at 1 year CA), or a control group (postponed: starting at 2 years CA). The control group will receive a placebo treatment. The effectiveness of early visual rehabilitation will be examined with follow-up visual and neurocognitive assessments after 1 year (upon completion of the direct intervention) and after 2 years (upon completion of the postponed intervention). Discussion Through this RCT we will establish the effectiveness of a new and early visual rehabilitation program. Combining a general and supplement protocol enables structured comparisons between participants and groups, and custom rehabilitation that is tailored to the children’s specific needs. The design ensures that all included children will benefit from participation by advancing the age at which they start receiving rehabilitation. We expect results to be applicable to all children with (a risk of) VPD early in life.

scholarly journals Effects of Traditional vs. iPad-Enhanced Aerobic Exercise on Wayfinding Efficacy and Cognition: A Pilot Randomized Controlled Trial

2019 ◽  
Vol 16 (18) ◽  
pp. 3495 ◽  
Author(s):  
Daniel Palac ◽  
Tiffany Bullard ◽  
Jason D. Cohen ◽  
Lydia T. Nguyen ◽  
Raksha A. Mudar ◽  
...  
Keyword(s):  
At Risk ◽  
Randomized Controlled Trial ◽  
Cognitive Impairment ◽  
Aerobic Exercise ◽  
Cognitive Functioning ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Experimental Group

The purpose of this pilot study was to test the feasibility and efficacy of an iPad-enhanced aerobic exercise intervention designed to enhance wayfinding efficacy and performance and relevant cognitive functioning among middle-aged adults at risk for cognitive impairment. Twenty-seven low active adults (21 females) aged 45 to 62 years (51.22 ± 5.20) participated in a ten-week randomized controlled trial. Participants were randomized to an iPad-enhanced aerobic exercise group (experimental group) or an aerobic exercise-only group (control group) following baseline assessment. Both groups exercised at 50% to 75% of age-predicted heart rate maximum for 30 to 50 min/d, 2 d/wk for 10 weeks. During aerobic exercise, the experimental group engaged in virtual tours delivered via iPad. Baseline and post-intervention assessments of wayfinding self-efficacy, wayfinding task performance, cognitive functioning, electroencephalogram (EEG), and psychosocial questionnaires were administered. The results suggest that ten weeks of iPad-enhanced, moderately intense aerobic exercise had specific effects on wayfinding self-efficacy; however, no statistical differences were found between groups on the behavioral wayfinding task or spatial memory performance at follow-up. Performance scores on an inhibitory attentional-control cognitive assessment revealed significant differences between groups, favoring the experimental group (p < 0.05). Virtual reality-enhanced aerobic exercise may prove to be an effective method for improving cognitive function and increasing confidence to navigate real-world scenarios among individuals at risk of cognitive impairment.

scholarly journals Evaluation of the Quick Wee method of inducing faster clean catch urine collection in pre-continent infants: a randomized controlled trial

2021 ◽  
Author(s):  
Aoife Branagan ◽  
Niofa Canty ◽  
Evanne O’Halloran ◽  
Marian Madden ◽  
Michael Brendan O’Neill
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Clinical Care ◽  
Intervention Group ◽  
Urine Samples ◽  
Absolute Difference ◽  
Control Group ◽  
Randomized Controlled ◽  
Irish Hospital ◽  
To Receive

Abstract Introduction The acquisition of non-contaminated urine samples in pre-continent infants remains a challenge. The Quick Wee method uses bladder stimulation to induce voiding. A previous randomized trial showed a higher rate of voiding within 5 minutes using this method. We evaluated this method in an Irish hospital providing secondary care. Methods A non-blinded, randomized, controlled trial was carried out. Eligible infants were between 1 and 12 months of age, who required urine sampling as part of clinical care. Participants were randomly allocated to receive the intervention (Quick Wee Method—supra-pubic stimulation with cold saline) or the control (usual care—clean catch with no bladder stimulation) for 5 min. Primary outcome was voiding of urine within 5 min. Results A total of 140 infants were included in this study (73 in intervention group; 67 in control group). Baseline characteristics were similar. 25% in the intervention group passed urine in the 5-min trial period compared with 18% in the control group [P = 0.4, absolute difference 7% (95% confidence interval: − 7% to + 20%)]. Conclusion The Quick Wee method is a simple and inexpensive intervention that did not show a statistically significant increase in urine samples obtained in pre-continent infants.

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