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Mother-mediated early intervention occupational therapy program

Effectiveness of a mother-mediated occupational therapy early intervention program with mobile-enabled adherence strategies to support mother’s self-efficacy and infant development

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/07/035150
Enrollment
216
Registered
2021-07-27
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

Health Condition 1: G988- Other disorders of nervous system

Interventions

Intervention1: Mother-Mediated occupational therapy early intervention(M-OTEI): Experimental group: The intervention will have three components as follows: At NICU: It will be in the NICU and during
strategies will be discussed and explored to facilitate the application of the OTEI at home in her daily routine. The mother will also be trained to use the mobile-based application. This may involve

Sponsors

ICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The study participants include preterm infants and their mother. For the infant, the inclusion criteria is: very preterm (28-32) weeks, moderate to late preterm (32-37 weeks). Preterm neonates with either sex, low birth weight, respiratory distress syndrome, birth asphyxia with Hypoxic Ischemic Encephalopathy stage I&II, neonatal seizures, intraventricular hemorrhage (Grade I to III) will be included in the study. Inclusion criteria for mother will be primigravida mother who understands Hindi/English/Kannada, has functional reading, comprehension, and communication, is willing to participate, with self-report of poor to fair maternal confidence in caring for their infant.

Exclusion criteria

Exclusion criteria: Infant: Sepsis with meningitis, neonates below 28 weeks of gestation, chromosomal anomalies, Severe perinatal asphyxia (HIE stage III), Intraventricular Hemorrhage grade IV, Spinomuscular atrophy etc., will be excluded. Mother:Mothers with presence of any medical, neurological or psychiatric (post partum depression, psychosis, etc.) complications that limits their comprehension, communication, and physical abilities to participate in the study based on medical records.

Design outcomes

Primary

MeasureTime frame
Perceived Maternal Parenting Self-efficacy Questionnaire (PMPS-E)Timepoint: 3 points 1:Initial evaluation(When the infant is there in NICU) 2: At or during discharge from NICU to home 3:Follow up at 6 months

Secondary

MeasureTime frame
Bayley Scales of Infant and Toddler Development (BSID)Timepoint: One point only Follow up time at the 6 months to measure the developmental pattern with respect to age;Parental Stress ScaleTimepoint: 3 points 1: During the initial evaluation( when the mother is in NICU with the infant) 2: during or at discharge from NIVu to home 3: At follow up(Six months)

Countries

India

Contacts

Public ContactRupambika Sahoo

MANIPAL ACADEMY OF HIGHER EDUCATION

sebestina.dsouza@manipal.edu576104

Outcome results

None listed

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