Are Developmentally At Risky Babies Environmentally Disadvantaged?

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age7-18
SponsorAbant Izzet Baysal University

About this trial

A study conducted on infants aged between 3 and 11 months revealed a positive relationship between the home environment and developmental outcomes. Similarly, another study found that variability in motor and cognitive development could be better explained by environmental factors and parental knowledge and practices. It has also been shown that the opportunities provided in the home environment of preterm infants may be associated with motor development and sensory processing skills. In the literature, it is generally observed that studies evaluate either term infants or both preterm and term infants together. In the present study, however, infants at developmental risk and typically developing infants will be evaluated separately.

The aim of this study is to assess whether infants at developmental risk are disadvantaged in terms of their home environment.

The hypotheses of this study are as follows:

H1-1: There is a difference in environmental arrangements between typically developing infants and those at developmental risk.

H1-2: There is a relationship between home environmental arrangements and motor development.

H1-3: There is a relationship between home environmental arrangements and sensory profile.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Infants with unstable vital signs

Trial population

Infants who were developmentally at risk, aged between 7 and 18 months, and whose parents consented voluntarily were included in the study. Infants who were hospitalized or had unstable vital signs were excluded. Typically developing infants aged 7 to 18 months with parental consent were included as the control group. Written informed consent was obtained from the parents of all participating infants.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

52 Participants
are grouped into 2 trial groups
Group A: risky babies
Group B: control group

Trial outcomes

Primary outcomes

1

Assessment of Home Environment Supporting Motor Development - Infant Scale (AHEMD-IS):

The AHEMD-SR, developed in 2005, evaluates the home environment of children aged 18-42 months. Recently, the 3-18 month version (AHEMD-IS) was validated to assess the quality and quantity of motor development opportunities at home. The scale has 41 items across four domains: Physical Space (indoor/outdoor), Variety of Stimulation, Gross Motor Toys, and Fine Motor Toys. Home environments are rated as excellent, adequate, moderate, or inadequate. For infants 3-11 months, 32 items are applicable; 12-18 months respond to all items. Responses include yes/no (0/1) and frequency scales from never (0) to always (3). Maximum scores are 66 for under 12 months and 93 for older infants; higher scores indicate better environmental enrichment. Turkish validity and reliability were confirmed with Cronbach's alpha of 0.846 and ICC of 0.830. Author permission was obtained.

Time frame
2 year

Secondary outcomes

1

Alberta Infant Motor Scale (AIMS):

AIMS is a standardized tool assessing gross motor development from birth to independent walking (up to 18 months). It identifies motor delays, monitors progress pre- and post-intervention, and evaluates rehabilitation effectiveness. Infants are observed in four positions: prone, supine, sitting, and standing. Movements related to weight-bearing, posture, and antigravity are scored. Each observed movement scores 1, unobserved 0, focusing on the "developmental window" of the two most mature movements. Scores per position are summed for a raw score, converted to age-based percentiles to assess motor level. Assessment takes 20-30 minutes, ideally with caregiver present for infant comfort. AIMS is widely used to profile infant motor development.

Time frame
2 year
2

Sensory Profile Assessment:

The Toddler Sensory Profile-2 (7-35 months) is a parent-report questionnaire designed to evaluate sensory processing in infants. It consists of 54 items and takes approximately 15 minutes to complete. In this study, it will be applied to infants aged 7-18 months. Parents rate the frequency of their child's responses to various sensory experiences on a 5-point scale: Almost Always (5), Often (4), Sometimes (3), Rarely (2), Almost Never (1), with an additional "Not Applicable" option. Total raw scores are classified using normative curves and sensory classification as follows: (i) Much less than others (\<2%), (ii) Less than others (1-2 SD below mean), (iii) Similar to most (±1 SD), (iv) More than others (1-2 SD above mean), (v) Much more than others (\>98%).

Time frame
2 year
3

Bayley Scales of Infant and Toddler Development - Third Edition (Bayley-III):

Bayley-III is a reliable and valid tool for assessing cognitive, language, and motor development in children aged 0-42 months. It identifies developmental delays and aids intervention planning. The scale provides raw scores, standard scores, percentile ranks, and growth scores, detailing performance in subscales: Cognitive, Receptive and Expressive Communication, Fine Motor, and Gross Motor. Scoring awards 1 point for correct and 0 for incorrect responses. Developmental scores range from 200 to 800 (mean=500, SD=100). The test follows basal and ceiling rules for item administration. Assessment requires a quiet, well-lit environment, fostering a warm, trusting interaction. Materials are engaging and hygienically maintained. Bayley-III is widely used by multidisciplinary teams for diagnosis and research, especially in early intervention. The research team's certified examiner will conduct the assessment.

Time frame
2 year

Other outcomes

Sponsors and contacts

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