Early Intervention in Children at Risk of Developmental Delay

Not Applicable

Completed

• Conditions: Developmental Delay
• Interventions: Other: Early Intervention; Other: Home Programme

• Registration Number: NCT06052410
• Lead Sponsor: Hacettepe University

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.

Study Timeline

• Study Start: 2022-09-03
• Primary Completion: 2022-11-26
• Study Completion: 2022-12-03
• Study First Submitted: 2023-09-19
• Study First Submitted QC: 2023-09-19
• Study First Posted: 2023-09-25
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-10
• Last Update Posted: 2023-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Early Intervention	The group in which the early intervention program was implemented.
Control Group	Home Programme	The group where the home program is applied

Primary Outcome Measures

Name	Time	Method
Infants/Toddler Sensory Profile 2 (ITSP 2)	10 minutes	It is a 5-point Likert type scale filled out by families that evaluates the sensory processing skills of children aged 7-35 months.

Secondary Outcome Measures

Name	Time	Method
Bayley Scales of Infant and Toddler Development III (Bayley III),	40 minutes	It is a scale in which children's gross motor, fine motor, communication and cognitive skills are evaluated by the therapist.
Ages and Stages Questionnaire (ASQ) and Ages and Stages Questionnaire- Social Emotional (ASQ-SE).	45 minutes	It is a scale in which children's gross motor, fine motor, communication, cognitive and social emotional skills are evaluated by the family.

Trial Locations

Locations (1)

Hacettepe University; 🇹🇷 Ankara, Altındag, Turkey