Investigation of the Effectiveness of Family Collaborative Early Intervention Approach Based on Sensory Strategies, Activity Based Motor Training and Environmental Enrichment in Premature Infants: SAFE National Early Intervention Approach
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Gazi University
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III)
Study Overview
Brief Summary
In this study, it was aimed to develop the SAFE treatment approach, which is a family collaborative early intervention approach based on sensory strategies, activity-based motor training and environmental enrichment, and to examine the effects of this approach on sensory, motor, cognitive and language development in premature infants.
Detailed Description
Early intervention practices in Turkey is widely based on the principle of neuro-developmental therapy (NDT). It has been reported in recent years that the NDT approach has minimal effect on the development of risky premature infants. For these reasons, it was necessary to develop an early intervention program that does not include passive interventions and includes sensory and motor strategies in our country.
Within the scope of this study, a new early intervention approach that can be applied to infants between 0-24 months has been developed based on the shortcomings in the literature. Sensory strategies, activity-based motor training, family collaboration and environmental enrichment constitute the basic principles of this early intervention program. The name of the early intervention program was formed from the English initials of these basic principles and was determined as SAFE early intervention approach (S: Sensory Strategies, A: Activity Based Motor Training, F: Family Collaboration, E: Environmental Enrichment).
In this study, it was planned to establish the theoretical and practical foundations of the SAFE early intervention approach developed by the Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation. Also we aimed to examine the effects of this approach on sensory, motor, cognitive and language development in preterm infants with corrected ages of 9-10 months.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 9 Months to 10 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Being born before 37 weeks
- •A history of Neonatal Intensive Care Unit (NICU) for 15 days or more
- •Adjusted age to be between 9-10 months
- •Family's willingness to participate in the study
Exclusion Criteria
- •Having a congenital anomaly or systemic disease
- •Having a high risk for the diagnosis of Cerebral Palsy (Intraventriculer hemorrhage (IVH) Stage 4 or periventricular leukomalacia (PVL) Stage 3-4, such as the absence of fidgety movements).
Arms & Interventions
SAFE early intervention group
A family collaborative treatment program based on sensory strategies, activity-based motor training and environmental enrichment principles was created for the infants in the treatment group. Within the scope of the SAFE treatment approach, appropriate activities were explained to the families. Families were asked to do these activities every day for 10 weeks. The compliance of the families with the program was monitored every week via phone calls or the WhatsApp phone program. In addition, families were asked to keep a diary and note the duration of the activity. The homes of the families in the treatment group were visited at least once. During this visit, home environment was evaluated. In order to create an enriched home environment, families were informed about the toys and materials that can be obtained. The family's questions about the program were answered.
Intervention: SAFE early intervention approach (Procedure)
Control group
Within the scope of this study, the infants in the control group were given an NDT-based family training program in accordance with their corrected months and current functional levels. In this context, appropriate activities were taught to families. Families were asked to do these activities every day for 10 weeks. The compliance of the families with the program was monitored every week via phone calls or the WhatsApp phone program. In addition, families were asked to keep a diary and note the duration of the activity. One visit was made to the homes of the families in the control group. The family's questions about the program were answered.
Intervention: SAFE early intervention approach (Procedure)
Outcomes
Primary Outcomes
The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III)
Time Frame: 10 weeks
Bayley-III is a widely used test battery to assess cognitive, receptive and expressive language, gross and fine motor development in children aged 1 to 42 months. The items in each section are scored as 1 (can do the desired skill) and 0 (cannot do the desired skill). The raw scores obtained from all items are converted into scale points ranging from 1 to 19 points. Then, a composite score is obtained according to this scale score. It is the composite score commonly used in studies. Composite scores range from 40 to 160. The higher the score, the better the improvement.
Secondary Outcomes
- Hammersmith Infant Neurological Examination (HINE)(10 weeks)
- The Test of Sensory Functions in Infants (TSFI)(10 weeks)
- Canadian Occupational Performance Measure (COPM)(10 weeks)
- Affordances in the Home Environment for Motor Development - Infant Scale (AHEMD-IS)(10 weeks)
- The Depression, Anxiety and Stress Scales-Short Form (DASS-21)(10 weeks)
Investigators
Umut Apaydin
Research assistant, PhD, PT.
Gazi University