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

• Register: ANZCTR
• Last refreshed on: 11 November 2019
• Main ID: ACTRN12618000932268
• Date of registration: 01/06/2018
• Prospective Registration: Yes
• Primary sponsor: Queensland Cerebral Palsy and Rehabilitation Research Centre, The University of Queensland
• Public title: VISIBLE: Vision Intervention for Seeing 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)
• Date of first enrolment: 06/08/2019
• Target sample size: 32
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12618000932268.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia, Italy

Contacts

• Name: Prof Roslyn Boyd

• Name: Prof Roslyn Boyd

Key inclusion & exclusion criteria

Inclusion criteria: i) Infants at home, available at 3-6 months + 29 days C.A,
ii) have a severe visual impairment (assessed by the Teller Acuity Cards according to the c.a. score table by month) see assessment manual for the table 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).
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

Age minimum: 3 Months
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Neurological - Other neurological disorders

Cerebral visual impairment;Cerebral palsy;
Cerebral visual impairment
Cerebral palsy

Eye - Diseases / disorders of the eye

Intervention(s)

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 mo

Primary Outcome(s)

Infant Battery for Vision [Baseline and 12 months corrected age]

Visual cognitive abilities score on the Preverbal Visual Assessment (PreViAs) questionnaire[Baseline and 12 months corrected age]

Score on the Peabody Developmental Motor Scales - 2 edition (PDMS-2)[Baseline and 12 months corrected age]

Secondary Outcome(s)

Brain Structure on MRI [12 months corrected age]

Parents of infants self-perception of performance will be assessed with the Canadian Occupational Performance Measure (COPM).[Baseline and 12 months corrected age for intervention group only]

Parents of infants score on the Emotional Availability Scales (EAS)[Baseline and 12 months corrected age]

Score on the Pediatric Evaluation of Disability Inventory- Computer Assisted Test (PEDI-CAT) [Baseline and 12 months corrected age]

Score on the Bayley Scales of Infant and Toddler Development Third Edition (BSID-III) Special Needs Addition [12 months corrected age]

Infant Toddler Quality of Life Questionnaire (ITQOL)[Baseline and 12 months corrected age]

Parents of infants score on the Depression Anxiety Stress Scale (DASS-21) [Baseline and 12 months corrected age]

Score on the Hammersmith Infant Neurological Examination (HINE) [Baseline and 12 months corrected age]

Secondary ID(s)

None

Source(s) of Monetary Support

Cerebral Palsy Alliance

Secondary Sponsor(s)

IRCCS Stella Maris

Ethics review

Status: Approved
Approval date:
Contact:

Children’s Health Queensland Human Research Ethics Committee

Status: Not approved
Approval date:
Contact:

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)

Status: Not approved
Approval date:
Contact:

The University of Queensland Human Research Ethics Committee