Early Intervention in Children at Risk of Developmental Delay

NCT06052410 | Completed

• 1 other identifier: Hacettepe Occupational Therapy
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Developmental Delay

Keywords

early intervention; developmental delay; motor development; cognitive development

Outcome Measures

Primary Outcomes (1)

• Infants/Toddler Sensory Profile 2 (ITSP 2)

  It is a 5-point Likert type scale filled out by families that evaluates the sensory processing skills of children aged 7-35 months.

  10 minutes

Secondary Outcomes (2)

• Bayley Scales of Infant and Toddler Development III (Bayley III),

  40 minutes

• Ages and Stages Questionnaire (ASQ) and Ages and Stages Questionnaire- Social Emotional (ASQ-SE).

  45 minutes

Study Arms (2)

Intervention Group

OTHER

The group in which the early intervention program was implemented.

Other: Early Intervention

Control Group

OTHER

The group where the home program is applied

Other: Home Programme

Interventions

Early Intervention OTHER

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.

Intervention Group

Home Programme OTHER

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.

Control Group

Eligibility Criteria

• Age: 24 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Babies staying in institutional care,
• Having any neurological, psychiatric or orthopedic diagnosis

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Altındag, 06050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Learning Disabilities

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Ezginur Gündoğmuş

  OT MSc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Occupational Therapist

Model Details: 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.

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: September 25, 2023
• Study Start: September 3, 2022
• Primary Completion: November 26, 2022
• Study Completion: December 3, 2022
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)