The effectiveness of the early intervention program using telemedicine in improving motor developmental outcomes among children at risk of developmental disorders: a randomized controlled trial

Effectiveness of the home-based early intervention program on infant development: a comparative study of in-person versus hybrid (in-person and telehealth) delivery

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN99924016

Enrollment

Registered

2025-08-08

Start date

2018-09-15

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Developmental disorders Mental and Behavioural Disorders

Interventions

Infants with abnormal general movements at 3 months of age were randomly assigned (1:1) using a computer-generated sequence to either a home-based telemedicine lead COPCA intervention group (with ther

allocation was concealed, masking was not applied, and participants remained in their assigned groups throughout the study. Intervention group: Infants received the COPCA early intervention program d

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 3 months of age at enrolment 2. Abnormal General Movement (GMs) 3. Parental consent 4. Lithuanian-speaking families living in Lithuania

Exclusion criteria

Exclusion criteria: 1. Genetic syndromes 2. Severe sensory impairments (blindness, deafness) 3. Progressive neurological disorders 4. Families unwilling to participate in follow-up

Design outcomes

Primary

Measure	Time frame
1. Infant motor development assessed using Infant Motor Profile (IMP): assesses the quality of spontaneous and voluntary motor behaviour in infants, focusing on motor coordination, variability, and performance. Evaluated at a baseline (3 months of age), post-intervention (6 months of age) and follow-up (18 months of age). 2. Infant cognitive and motor development assessed using the Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III), a standardised assessment of fine motor, gross motor, and cognitive development in infants. Evaluated at a baseline (3 months of age), post-intervention (6 months of age) and follow-up (18 months of age).	—

Measure

Time frame

1. Infant motor development assessed using Infant Motor Profile (IMP): assesses the quality of spontaneous and voluntary motor behaviour in infants, focusing on motor coordination, variability, and performance. Evaluated at a baseline (3 months of age), post-intervention (6 months of age) and follow-up (18 months of age). 2. Infant cognitive and motor development assessed using the Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III), a standardised assessment of fine motor, gross motor, and cognitive development in infants. Evaluated at a baseline (3 months of age), post-intervention (6 months of age) and follow-up (18 months of age).

—

Secondary

Measure	Time frame
1. Parental stress and anxiety assessed using the Parenting Stress Index - Short Form (PSI-IS): assesses levels of stress and anxiety experienced by parents in the context of caring for an infant. Evaluated at a baseline (3 months of age), post-intervention (6 months of age) and follow-up (18 months of age). 2. Home environment affordances assessed using the Affordances in the Home Environment for Motor Development - Infant Scale (AHEMD-IS): quality and quantity of motor development opportunities available in the infant's home environment. Evaluated at a baseline (3 months of age), post-intervention (6 months of age) and follow-up (18 months of age).	—

Measure

Time frame

1. Parental stress and anxiety assessed using the Parenting Stress Index - Short Form (PSI-IS): assesses levels of stress and anxiety experienced by parents in the context of caring for an infant. Evaluated at a baseline (3 months of age), post-intervention (6 months of age) and follow-up (18 months of age). 2. Home environment affordances assessed using the Affordances in the Home Environment for Motor Development - Infant Scale (AHEMD-IS): quality and quantity of motor development opportunities available in the infant's home environment. Evaluated at a baseline (3 months of age), post-intervention (6 months of age) and follow-up (18 months of age).

—

Countries

Lithuania

Contacts

Public ContactKristina Zalanskiene

kristina.janaviciute@lsmuni.lt+370 (0)65373384

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026