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Trial registered on ANZCTR


Registration number
ACTRN12618000932268
Ethics application status
Approved
Date submitted
8/03/2018
Date registered
1/06/2018
Date last updated
1/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
VISIBLE: early Vision Intervention for Severely Impaired Babies: Learning through Enrichment
Scientific title
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)
Secondary ID [1] 294233 0
None
Universal Trial Number (UTN)
Trial acronym
VISIBLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral visual impairment 306911 0
Cerebral palsy 306912 0
Condition category
Condition code
Eye 306004 306004 0 0
Diseases / disorders of the eye
Neurological 306005 306005 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 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 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.
Intervention code [1] 300531 0
Rehabilitation
Intervention code [2] 301334 0
Treatment: Other
Comparator / control treatment
The standard of care group will receive their usual therapy services and participate in the assessments for the study.
Control group
Active

Outcomes
Primary outcome [1] 305040 0
Visual function score on the Ricci Visual Assessment Scale for newborns and infants
Timepoint [1] 305040 0
12 months corrected age
Primary outcome [2] 305041 0
Visual cognitive abilities score on the Preverbal Visual Assessment (PreViAs) questionnaire
Timepoint [2] 305041 0
12 months corrected age
Primary outcome [3] 305045 0
Score on the Peabody Developmental Motor Scales - 2 edition (PDMS-2)
Timepoint [3] 305045 0
12 months corrected age
Secondary outcome [1] 343980 0
Score on the Bayley Scales of Infant and Toddler Development Third Edition (BSID-III) Special Needs Addition
Timepoint [1] 343980 0
12 months corrected age
Secondary outcome [2] 343981 0
Score on the Hammersmith Infant Neurological Examination (HINE)
Timepoint [2] 343981 0
12 months corrected age
Secondary outcome [3] 343982 0
Brain Structure on MRI
Timepoint [3] 343982 0
24 months corrected age
Secondary outcome [4] 343983 0
Parents of infants self-perception of performance will be assessed with the Canadian Occupational Performance Measure (COPM).
Timepoint [4] 343983 0
12 months corrected age
Secondary outcome [5] 343984 0
Infant Toddler Quality of Life Questionnaire (ITQOL)
Timepoint [5] 343984 0
12 months corrected age
Secondary outcome [6] 343985 0
Parents of infants score on the Depression Anxiety Stress Scale (DASS-21)
Timepoint [6] 343985 0
12 months corrected age
Secondary outcome [7] 343986 0
Score on the Pediatric Evaluation of Disability Inventory- Computer Assisted Test (PEDI-CAT)
Timepoint [7] 343986 0
12 months corrected age
Secondary outcome [8] 343987 0
Parents of infants score on the Emotional Availability Scales (EAS)
Timepoint [8] 343987 0
12 months corrected age

Eligibility
Key inclusion criteria
i) Infants at home, identified between at 3-6 months C.A and their parents,
ii) have a severe visual impairment (visual acuity below 1cycle/deg) and
iii) a diagnosis of CP OR diagnosis of “high risk of CP” per the International Clinical Guideline for Accurate Early Detection (Novak et al., 2017).
Minimum age
3 Months
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) Infants with a medical fragility preventing the ability to participate in the activities;
ii) anatomical malformations preventing any vision (e.g. bilateral anophthalmia or microphthalmia);
iii) drug resistant epilepsy per the International League Against Epilepsy criteria;
and their parents

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Analysis will follow standard methods for RCTs using between groups comparisons using SPSS program. Intention-to-treat analysis will be followed to minimise inflation of treatment effects consistent with CONSORT guidelines. The hypotheses relating to intervention efficacy will be tested using general linear models, specifically via ANCOVA. Where continuous data exhibit substantial skewness not overcome by transformation, non-parametric methods will be used for simple comparisons.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC
Recruitment hospital [1] 10303 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 10304 0
Mater Mother's Hospital - South Brisbane
Recruitment hospital [3] 10306 0
Gold Coast University Hospital - Southport
Recruitment hospital [4] 10307 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [5] 10308 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment hospital [6] 10321 0
Perth Children's Hospital - Nedlands
Recruitment hospital [7] 10323 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [8] 10993 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 21972 0
4029 - Herston
Recruitment postcode(s) [2] 21973 0
4101 - South Brisbane
Recruitment postcode(s) [3] 21975 0
4215 - Southport
Recruitment postcode(s) [4] 21976 0
4575 - Birtinya
Recruitment postcode(s) [5] 21989 0
6009 - Nedlands
Recruitment postcode(s) [6] 21991 0
2145 - Westmead
Recruitment postcode(s) [7] 22784 0
3052 - Parkville
Recruitment outside Australia
Country [1] 9657 0
Italy
State/province [1] 9657 0
Pisa

Funding & Sponsors
Funding source category [1] 298872 0
Charities/Societies/Foundations
Name [1] 298872 0
Cerebral Palsy Alliance
Address [1] 298872 0
187 Allambie Road,
Allambie Heights NSW 2100
Country [1] 298872 0
Australia
Primary sponsor type
University
Name
Queensland Cerebral Palsy and Rehabilitation Research Centre, The University of Queensland
Address
UQ Child Health Research Centre
The University of Queensland
Centre for Children’s Health Research
62 Graham Street
South Brisbane, QLD 4101
Country
Australia
Secondary sponsor category [1] 298079 0
Charities/Societies/Foundations
Name [1] 298079 0
IRCCS Stella Maris
Address [1] 298079 0
Department of Developmental Neuroscience
IRCCS Stella Maris
Viale del Tirreno 331
Pisa 56128
Country [1] 298079 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299813 0
Children’s Health Queensland Human Research Ethics Committee
Ethics committee address [1] 299813 0
Children’s Health Queensland Hospital and Health Service
Level 7, Centre for Children’s Health Research
Lady Cilento Children’s Hospital Precinct
62 Graham Street
South Brisbane QLD 4101
Ethics committee country [1] 299813 0
Australia
Date submitted for ethics approval [1] 299813 0
12/03/2018
Approval date [1] 299813 0
09/05/2018
Ethics approval number [1] 299813 0
Ethics committee name [2] 299850 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [2] 299850 0
Level 3, Brian Wilson Chancellery
The University of Queensland
St Lucia QLD 4072, Australia
Ethics committee country [2] 299850 0
Australia
Date submitted for ethics approval [2] 299850 0
26/03/2018
Approval date [2] 299850 0
Ethics approval number [2] 299850 0
Ethics committee name [3] 299859 0
Il Comitato etico pediatrico (CEP), è una sezione del Comitato etico regionale della Toscana (Committee of Ethics for Pediatrics CEP, section for the Tuscan region)
Ethics committee address [3] 299859 0
Viale Pieraccini 28
Firenze, FL 50139,
Ethics committee country [3] 299859 0
Italy
Date submitted for ethics approval [3] 299859 0
26/03/2018
Approval date [3] 299859 0
Ethics approval number [3] 299859 0

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81646 0
Prof Roslyn Boyd
Address 81646 0
Rm 611, level 6
Childrens Health Research Centre,
62 Graham Street
South Brisbane
Queensland 4101
Country 81646 0
Australia
Phone 81646 0
+61 7 3069 7372
Fax 81646 0
Email 81646 0
r.boyd@uq.edu.au
Contact person for public queries
Name 81647 0
Prof Roslyn Boyd
Address 81647 0
Rm 611, level 6
Childrens Health Research Centre,
62 Graham Street
South Brisbane
Queensland 4101
Country 81647 0
Australia
Phone 81647 0
+61 7 3069 7372
Fax 81647 0
Email 81647 0
r.boyd@uq.edu.au
Contact person for scientific queries
Name 81648 0
Prof Roslyn Boyd
Address 81648 0
Rm 611, level 6
Childrens Health Research Centre,
62 Graham Street
South Brisbane
Queensland 4101
Country 81648 0
Australia
Phone 81648 0
+61 7 3069 7372
Fax 81648 0
Email 81648 0
r.boyd@uq.edu.au

No data has been provided for results reporting
Summary results
Not applicable