Sensitivity Training for Parents With Premature Infants

Not Applicable

Completed

• Conditions: Premature Birth

• Registration Number: NCT04383340
• Lead Sponsor: The University of Hong Kong

Brief Summary

This study evaluated the effectiveness of a culturally adapted version of the Mother-Infant Transaction Program (MITP) among Chinese mothers with premature infants in public hospitals in Hong Kong.

Detailed Description

Potential participants at two public hospitals in Hong Kong were identified by ward nurses. Mother-infant dyads with infants born at 36 weeks or earlier were assessed for eligibility. Data collection was conducted after obtaining written consent from the mothers. Mother-infant dyads who met the inclusion criteria were randomly allocated to either the intervention or the treatment-as-usual control group. Each dyad was assessed at six time points, i.e., baseline, immediately after intervention/TAU, and when the infants were at the gestation-corrected ages of 3, 6, 9, and 12 months.

Study Timeline

• Study Start: 2018-02-01
• Primary Completion: 2019-08-31
• Study Completion: 2019-08-31
• Status Verified: 2020-05
• Study First Submitted: 2020-05-05
• Study First Submitted QC: 2020-05-06
• Study First Posted: 2020-05-12
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 68

Inclusion Criteria

• Mothers with premature infants born at 36 weeks or earlier

Exclusion Criteria

• insufficient spoken and written Chinese ability of the mother
• mother under 18 years of age
• triplets or higher multiples
• infants with congenital abnormalities (e.g., metabolic disorder, chromosomal disorder)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Maternal postnatal depression	At infant's corrected age of 6 months	Maternal depression measured by the Edinburgh Postnatal Depression Scale. Possible scores range from 0 to 30. Higher scores indicate higher levels of depression.
Parenting stress	At infant's corrected age of 6 months	Parenting stress measured by the Parenting Stress Index-Short Form. Possible scores range from 36 to 180. Higher scores indicate higher levels of parenting stress.
Infant's temperament	At infant's corrected age of 6 months	Infant's soothability based on the Infant Behavior Questionnaire. A higher average score denotes higher soothability of the infant, and the highest possible score is 7.
Behavioral observation of mother-infant interactions	At infant's corrected age of 6 months	Maternal sensitivity and quality of mother-infant interaction measured by coding a 5-min video of mother-infant interaction. The coded variables are rated on a 5-point scale, and higher scores indicate higher maternal sensitivity and better interaction quality.
Infant's weight gain	At infant's corrected age of 12 months	Infant's weight gain from birth
Infant's developmental outcomes	At infant's corrected age of 12 months	Measured by the Cognitive Battery of the Merrill-Palmer-Revised Scales of Development, which includes assessments in the cognitive, receptive language, and fine motor domains. Higher scores denote better performance in the assessments

Trial Locations

Locations (1)

University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong