Early Intervention in Children at Risk of Developmental Delay

Developmental Delay Clinical Trial

Official title:

The Effect of Early Intervention on Sensory, Cognitive and Motor Outcomes in Children at Risk of Developmental Delay: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06052410
• Other study ID #: Hacettepe Occupational Therapy
• Status: Completed
• Phase: N/A
• Start date: September 3, 2022
• Est. completion date: December 3, 2022

Study information

• Verified date: October 2023
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 3, 2022
• Est. primary completion date: November 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Months to 36 Months

Eligibility

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

Related Conditions & MeSH terms

• Developmental Delay

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara	Altindag

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

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