Explorer Babies Early Intervention Program

The Effect of New Holistic Early Intervention Approach (Explorer Babies): a Randomized Controlled Study

Premature babies have a high risk of adverse developmental outcomes. Early intervention approaches are applied to reduce these adverse outcomes or support of developmental delay. Early intervention approaches may vary depending on developmental priorities. While some early intervention methods can consider body structured findings such as posture, tonus, muscle power, others may consider coaching family, enrichment of the environment. The explorer baby program is developed based on the trial and error process. The program tries to find an answer to a unique question: "how trial behavior in infants can be increased and which behaviors of the infants should be supported to increase their trial process?" The Explorer baby program tries to increase exploratory motor behaviors to facilitate development. For this aim, the program tries to explain how a baby learns new skills such as rolling, sitting, babbling, playing peek a boo, etc. in all domains of development while the baby lives in their natural environment. This study aims to investigate the effect of the explorer baby early intervention program.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy; Developmental Disability; Development, Infant; Motor Disorders; Premature
• Intervention / Treatment: Behavioral: The Explorer Baby Early Intervention Program; Other: Neurodevelopmental Therapy

Detailed Description

The aim of the study is to investigate the effect of Explorer Baby Early Intervention Program on explorative motor behaviors, motor, language, and cognitive skills. The study is designed as a randomized controlled trial in which infants and their families are randomly assigned to the intervention group (Explorer Baby) or control group (neurodevelopmental therapy), stratified by birth weeks and educational level of the mother.

There is no developmental support program as standard care in Turkey for premature babies. So that neither intervention nor the control group doesn't take any other support. There will be an average of six intervention sessions during the 6 months intervention period. The assessments will take before intervention (T0), after 3 months after T0 (T1) and after six months after T0 (T2), corrected age one (T3), corrected age two (T4).

Intervention: EXPLORatory motor behavior based Early Intervention Program (Explorer Baby) is a developmental support program for babies and their families. Parents visit the early intervention center with their babies in a variable frequency. The first step of the program is to build up interaction between therapists and parents; worries of parents for the development of their babies, knowledge about child development, knowledge about play behaviors, how babies learn new skills, age-specific requirements of babies, build up interaction with babies and family members, describing blocks for development.

The second step is setting the play in the natural environment working with the family; how do families describe the play? If families want to support the ability of their babies kicking, reaching, rolling, communicate, or social interaction how should they organize the playground? Showing families some examples of enrichment of playground for specific aims.

The third step is observing babies' reactions; how do families motivate their babies for play? How do families encourage their babies for self-starting explorative behaviors? How do parents support making the voice of the baby more if the play context is meaningful for creating a voice? The program doesn't give specific play homework to improve specific skills. The program tries to enrich parents' knowledge about the effect on the behavior of babies in meaningful situations.

The control Group: The control group will take neurodevelopmental therapy. Neurodevelopmental therapy is commonly accepted as traditional therapy.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34854
    • Marmara University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 months (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Born before than 33 weeks

Exclusion Criteria:

• congenital malformations, all levels of asphyxia, intracranial hemorrhage, periventricular leukomalacia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: The Explorer Early Intervention Program; The Explorer Early Intervention Program is used in this group.	Behavioral: The Explorer Baby Early Intervention Program; Centered based intervention, once or twice a month, 6 months follow up; Other Names: Explorer Baby
ACTIVE_COMPARATOR: Neurodevelopmental Therapy; Neurodevelopmental therapy is used in these group by two experienced and certificated physiotherapist	Other: Neurodevelopmental Therapy; Centered based intervention, once or twice a month, 6 months follow up; Other Names: Bobath

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III)	The Bayley III is assessing "Cognitive, Receptive Language, Expressive Language, Fine Motor, Gross Motor". Bayley III has a raw score, scale score, composite score, and growth percentile score. All of these scores will be given in the study. But only, the growth percentage score will be discussed as both the subareas and the total score as the primary outcome. Because only the percentage of growth gives the baby's level of development exactly day by day. The percentile score is between 0 and 100. A higher score means improvement is better. The changes in the growth percentage in pre-test and post-test (T0-T1, T1-T2, T0-T2) will be examined in-group. Also, the growth percentage scores of two groups will be compared before, during and after the therapy (intergroup). This tool will be used to assess the change between the three-time points.	This tool will be used to assess the change between the three-time points. These time points are before therapy (T0), during therapy (T1 - 3 months after T0) and after therapy (T2 - 6 months after T0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age and Stage Questionnaire 2 (ASQ-2)	The Ages and Stages Questionnaire 2 (ASQ-2) is a widely used screening tool for infants and young children's development assessing development in five domains: Communication, Gross Motor, Fine Motor, Problem Solving and Personal Social. It is is originally a parent-completed questionnaire and it includes six questions for every developmental area. There are three options for the answer "Yes (10 points), Sometimes (5 points), No (0 points)". The raw score is between 0 to 60 points. High points mean better development. The study will use the raw score of all developmental areas. The age range of ASQ-2 is 3 months to 72 months meaning the ASQ-2 will not be used for children younger than 3 months. Post-tests (T1-T2) results will be used for discrimination (according to the parent's view) between children with developmental delays and developing typically in two groups.	This tool will be used to assess the change between the three-time points. These time points are before therapy (T0), during therapy (T1 - 3 months after T0) and after therapy (T2 - 6 months after T0)
Parent Stress Index-4-Short Form (PSI SF-4)	The questionnaire is assessing "Parental Distress, Parent-Child Dysfunctional Interaction, Difficult Child" subheadings. High points are mean high-stress behaviour. The raw score is between 36 to 180 points. There are no cut scores in the Turkish version of PSI-4 SF. The changes in the raw scores in pre-test and post-test (T0-T1, T1-T2, T0-T2) will be examined in-group. Also, the raw scores of two groups will be compared before, during and after the therapy (intergroup). This tool will be used to assess the change between the three-time points.	This tool will be used to assess the change between the three-time points. These time points are before therapy (T0), during therapy (T1 - 3 months after T0) and after therapy (T2 - 6 months after T0)
Infant Movement Motivation Questionnaire	The Questionnaire is assessing four subheadings with 27 items: "Activity, exploration, motivation, adaptability". There are no cut scores in these in the Turkish version of the questionnaire. High points mean better development. The raw score is between 27 to 135 points. The changes in the raw scores in pre-test and post-test (T0-T1, T1-T2, T0-T2) will be examined in-group. Also, the raw scores of two groups will be compared before, during and after the therapy (intergroup). This tool will be used to assess the change between the three-time points.	This tool will be used to assess the change between the three-time points. These time points are before therapy (T0), during therapy (T1 - 3 months after T0) and after therapy (T2 - 6 months after T0)

Collaborators and Investigators

• Sponsor: Marmara University
• Investigators: Study Director: Zübeyir Sarı, PhD, Marmara University

Publications and helpful links

General Publications

• Babik I, Galloway JC, Lobo MA. Infants Born Preterm Demonstrate Impaired Exploration of Their Bodies and Surfaces Throughout the First 2 Years of Life. Phys Ther. 2017 Sep 1;97(9):915-925. doi: 10.1093/ptj/pzx064.
• de Campos AC, Savelsbergh GJ, Rocha NA. What do we know about the atypical development of exploratory actions during infancy? Res Dev Disabil. 2012 Nov-Dec;33(6):2228-35. doi: 10.1016/j.ridd.2012.06.016. Epub 2012 Jul 21.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2018
• Primary Completion (ACTUAL): September 1, 2019
• Study Completion (ACTUAL): April 30, 2020

Study Registration Dates

• First Submitted: November 21, 2019
• First Submitted That Met QC Criteria: December 16, 2019
• First Posted (ACTUAL): December 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 4, 2020
• Last Update Submitted That Met QC Criteria: September 3, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Cerebral Palsy; Premature; Early Intervention; Developmental Disability; Motor Disorder; developmental Support
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Neurodevelopmental Disorders; Cerebral Palsy; Developmental Disabilities; Motor Disorders
• Other Study ID Numbers: 09.2017.729

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study will share the outcomes of statistics by using tables, figures.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No