RecruitingACTRN12618000932268

VISIBLE: Vision Intervention for Seeing Impaired Babies: Learning through Enrichment

Multisite pragmatic Pilot RCT feasibility and acceptability study of a 6-month early vision-awareness & parent-directed environmental enrichment program for infants with severe cerebral visual impairment (CV)I and high risk of cerebral palsy (CP)


Sponsor

Queensland Cerebral Palsy and Rehabilitation Research Centre, The University of Queensland

Enrollment

32 participants

Start Date

Aug 6, 2019

Study Type

Interventional

Conditions

Summary

To conduct a multisite pragmatic RCT pilot study of early vision-aware and parent-directed environmental enrichment program (VISIBLE: early Vision Intervention for Seeing Impaired Babies: Learning through Enrichment) which aims to: 1. Determine the feasibility and acceptability of the VISIBLE intervention program for infants with severe CVI and high risk of Cerebral Palsy. 2. Evaluate efficacy of the VISIBLE program to lead to greater improvements of (i) visual function, (ii) developmental outcomes (developmental, motor, fine motor) and (iii) parent infant emotional and relational development, as compared to standard of care (SoC). VISIBLE is an early intervention program based on the core principles of optimising infant’s visual experience during the first phases of development. The general principles are activity-dependent learning and environmental enrichment. Parents are essential to environmental enrichment for infant learning success. They provide the environmental cues for both social and physical infant exposure. Utilizing this principle, parents will provide vision-awareness environmental enrichment – adapting the social and physical environment to allow the infant the opportunities to learn by successfully experiencing their enhanced environment. Within the context of parent-child daily goal-oriented interactions, environmental enrichment, as it relates to vision-awareness modifications, will include light, spatial distances, salience, consistency and multimodality of infant’s environment. The major hypothesis to be tested is: H1Infants with severe CVI and high risk of Cerebral Palsy who receive the VISIBLE program will have superior visual behaviour scores at 12-months of age, compared to those who receive standard care. The secondary hypotheses are: H2 Infants with severe CVI and high risk of Cerebral Palsy who receive the VISIBLE program will have superior cognitive scores on the Bayley Scales of Infant Development and/or superior motor scores on Peabody Developmental Motor Scales at 12-months of age, compared to those who receive standard care. H3Parents will find the VISIBLE program intervention feasible and acceptable to implement.


Eligibility

Sex: Both males and femalesMin Age: 3 Monthss

Plain Language Summary

Simplified for easier understanding

Cerebral visual impairment (CVI) — where the brain rather than the eyes is the main cause of visual difficulties — is the leading cause of vision problems in children in high-income countries. It often occurs alongside cerebral palsy (CP). This study is testing an early intervention program called VISIBLE, designed to help infants with severe CVI and high risk of cerebral palsy make the most of their visual potential during the critical early months of brain development. The VISIBLE program trains parents to modify their baby's environment — adjusting light, distance, colour contrast, and how they interact during daily activities — so that the baby gets more meaningful visual experiences. Parents are the central agents of this therapy because they are with their baby every day. The program will be compared to standard care to see if it leads to better visual and developmental outcomes by 12 months of age. This study is for infants who are 3 to 6 months of corrected age, have severe visual impairment confirmed by testing, and have been diagnosed with cerebral palsy or are at high risk of it. Infants with drug-resistant epilepsy, complete absence of functional eyes, or medical fragility that prevents participation are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

VISIBLE is an early intervention program based on the core principles of optimising infant’s visual experience during the first phases of development. The general principles are activity-dependent lea

VISIBLE is an early intervention program based on the core principles of optimising infant’s visual experience during the first phases of development. The general principles are activity-dependent learning and environmental enrichment. Parents are essential to environmental enrichment for infant learning success. They provide the environmental cues for both social and physical infant exposure. Utilizing this principle, parents will provide vision-awareness environmental enrichment – adapting the social and physical environment to allow the infant the opportunities to learn by successfully experiencing their enhanced environment. Within the context of parent-child daily goal-oriented interactions, environmental enrichment, as it relates to vision-awareness modifications, will include light, spatial distances, salience, consistency and multimodality of infant’s environment. The program will be lead and supported by multidisciplinary teams at each institution, including Paediatric Neurologists, Ophthalmologists, Paediatric developmental therapists. Between 12-18 fortnightly home or telehealth visits will be conducted over a 6-9 month period concluding at 12 months corrected age dependent on the age at entry, will be undertaken by VISIBLE-trained developmental therapists to contextualise the EI program to the infant’s natural environment. The first home or telehealth visit for the VISIBLE group families will include parent training and information about and demonstration of activities appropriate for their infant. The following visits (90 -120 minutes) will include direct activities with the parents and infant, coaching on advancement of activities to accommodate infant’s emerging skills and parent treatment fidelity checks. Optimising infant’s visual experience: environmental modifications based on the family unit and infant’s individualized goals, such as perceptual adaptation (e.g. lighting and colour contrasts) and organization of the physical environment (e.g. distances, speed of moving objects etc.). We will systematically teach parents the essential aspects of visual awareness modification of the environment and activities to allow their infant successful engagement with their social and physical environment during both play and targeted developmental activities. Social and emotional goals (e.g. reacting to differing facial expressions) are first identified by the parent. The factors for learning to advance performance, with specific focus on visual attention and the adaptation of the physical environment, are identified by the therapist and discussed with the family (e.g. improved lighting and reduced distance). Parents are coached on visual awareness strategies to promote learning, movement and social interaction. Parent-infant interactions are adaptive, supportive, and consistent. Training through developmentally appropriate play is conducted at the limit of the infant’s performance ability with variation and increasing complexity built into the play activities.


Locations(11)

Royal Brisbane & Womens Hospital - Herston

NSW,QLD,WA,VIC, Australia

Mater Mother's Hospital - South Brisbane

NSW,QLD,WA,VIC, Australia

Gold Coast University Hospital - Southport

NSW,QLD,WA,VIC, Australia

Sunshine Coast University Hospital - Birtinya

NSW,QLD,WA,VIC, Australia

Perth Children's Hospital - Nedlands

NSW,QLD,WA,VIC, Australia

The Children's Hospital at Westmead - Westmead

NSW,QLD,WA,VIC, Australia

The Royal Childrens Hospital - Parkville

NSW,QLD,WA,VIC, Australia

Queensland Children's Hospital - South Brisbane

NSW,QLD,WA,VIC, Australia

The Townsville Hospital - Douglas

NSW,QLD,WA,VIC, Australia

Cairns Base Hospital - Cairns

NSW,QLD,WA,VIC, Australia

Pisa, Italy

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ACTRN12618000932268