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Early Intervention in Children at Risk of Developmental Delay

NCT06052410 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-10-11

No results posted yet for this study

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.

Conditions

  • Developmental Delay

Interventions

OTHER

Early Intervention

Based on the principles of the Goal, Activity and Motor Enrichment (GAME) approach, which is an evidence-based early intervention approach for children at risk of developmental delay between 24-36 months, activity-based training is aimed at the development of sensory and cognitive skills in addition to the training of motor skills, which are intensively discussed in the content of the approach. Individualized early occupational therapy intervention including strategies was implemented.

OTHER

Home Programme

For the control group, evaluation tests were first applied to the babies selected by simple random sampling method. An individualized home program was given according to the evaluation results. Home programs include activities for every skill area and were prepared together with the parents, taking into account the criteria suggested for the success of the home program. Based on these criteria, it was checked whether the family had received another home program, and while preparing the program, care was taken not to overload the parents, importance was given to the family's willingness to receive the home program, activities and goals were decided in cooperation with the parent, thus facilitating the applicability of the activities in daily life, ensuring that the number of activities was 6. Care was taken to ensure that the activity was not too much, the parent was given the necessary time to implement the program, and a phone call was made to the parent every 3 weeks.

Sponsors & Collaborators

  • Hacettepe University

    lead OTHER

Principal Investigators

  • Ezginur Gündoğmuş · OT MSc

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
24 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-03
Primary Completion
2022-11-26
Completion
2022-12-03

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06052410 on ClinicalTrials.gov