Clinical trial NCT06052410: Early Intervention in Children at Risk of Developmental Delay
Official title: The Effect of Early Intervention on Sensory, Cognitive and Motor Outcomes in Children at Risk of Developmental Delay: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Developmental Delay
Keywords: early intervention
developmental delay
motor development
cognitive development
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 70
Sex: ALL
Minimum age (years): 24
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Sensory development is targeted in activity-based education based on the principles of the Goal, Activity and Motor Enrichment (GAME) approach, which is an evidence-based early intervention approach for children between 24-36 months at risk of developmental delay. The program was implemented in the pediatric unit for 45 minutes a day, twice a week for 12 weeks. For the control group, evaluation tests were first applied to babies selected by simple random sampling method. According to the evaluation results, a personalized home program was given. Post-evaluations were repeated for both groups after 12 weeks. The basic principles of the GAME approach are examined in 3 parts: goal-oriented intensive motor training, parent training, environmental enrichment. In our study, activities were also implemented based on the sensory integration approach and cognitive rehabilitation intervention principles to present sensory and cognitive strategies within the activity.
Primary purpose: PREVENTION

Brief summary: Although it is stated in the literature that development should be considered as a whole and sensory, cognitive and motor outcomes are interrelated, it is seen that interventions for sensory and cognitive skills are not included in early intervention studies. For this reason, the study examined the effects of an early occupational therapy intervention program, which includes sensory, cognitive and motor strategies based on the principles of Goal, Activity and Motor Enrichment-GAME, an evidence-based early intervention program, on the sensory, cognitive and motor skills of babies at risk of developmental delay for 24-36 months.

Detailed description: Children with developmental delays benefit from early intervention. Therefore, it is very important to detect developmental delays as early as possible. In recent years, there has been increasing interest in designing and providing early intervention programs to improve developmental outcomes for infants at risk for developmental delay for neurodevelopmental disorders. Early intervention includes services provided to children from birth to age five to promote the child's health and well-being, develop emerging skills, minimize developmental delays, correct existing or emerging disabilities, prevent functional impairment, and promote parental compliance. When the literature is examined, it is seen that early intervention approaches are mostly implemented in preterm babies and focus on motor skills. An example of studies carried out with this attitude is Neurodevelopmental Treatment (NGT), which is frequently used in early intervention approaches in Turkey. Another early intervention approach that includes intensive motor training is Goal, Activity and Motor Enrichment (GAME). GAME early intervention approach is also used in extremely preterm babies with a high risk of developmental delay; It has been used in studies as an intervention approach that includes goal-oriented motor training, environmental enrichment and family education. Another early intervention approach that addresses parent education and environmental enrichment principles is the Supporting Play, Exploration and Early Development Intervention (SPEEDI). The SPEEDI program was applied to preterm babies in a similar way to the GAME program. Other approaches used by occupational therapists for children at risk of developmental delay in the literature are home-based and routine-based approaches.

When the literature is examined, it is seen that early intervention programs are mostly carried out with premature babies and/or for the diagnosis of cerebral palsy (CP). Early intervention approaches in the literature include intensive motor training, parent training, environmental enrichment, participation support and home visits. Although it is stated in the literature that development should be considered as a whole and sensory, cognitive and motor outcomes are interrelated, it is seen that interventions for sensory and cognitive skills are not included in early intervention studies. Therefore, the aim of our study is to improve the sensory, cognitive and motor skills of the early occupational therapy intervention program, which includes sensory, cognitive and motor strategies based on the principles of Goal, Activity and Motor Enrichment-GAME, which is an evidence-based early intervention program, in babies at risk of developmental delay of 24-36 months. to examine its effect.

Eligibility criteria: Inclusion Criteria:

1. Being at risk of developmental delay between 24 and 36 months
2. Not having received any neurological, psychiatric or orthopedic diagnosis,
3. The family is willing to participate in the study and agrees to participate regularly in the intervention program and evaluations.

Exclusion Criteria:

1. Babies staying in institutional care,
2. Having any neurological, psychiatric or orthopedic diagnosis

Primary outcomes:
measure: Infants/Toddler Sensory Profile 2 (ITSP 2)
timeFrame: 10 minutes
Secondary outcomes:
measure: Bayley Scales of Infant and Toddler Development III (Bayley III),
timeFrame: 40 minutes
measure: Ages and Stages Questionnaire (ASQ) and Ages and Stages Questionnaire- Social Emotional (ASQ-SE).
timeFrame: 45 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Altındag
Study officials:
affiliation: OT MSc
name: Ezginur Gündoğmuş
role: STUDY_DIRECTOR
References: