Clinical trial NCT04383340: Sensitivity Training for Parents With Premature Infants
Official title: Sensitivity Training for Mothers With Premature Infants: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Keywords: sensitivity training
mother-infant interaction
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Hospital Authority, Hong Kong
First posted: 2020-05-12
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Behavioral observation of mother-infant interactions
timeFrame: At baseline prior to intervention
measure: Behavioral observation of mother-infant interactions
timeFrame: Immediately after intervention
measure: Behavioral observation of mother-infant interactions
timeFrame: At infant's corrected age of 3 months
measure: Behavioral observation of mother-infant interactions
timeFrame: At infant's corrected age of 6 months
measure: Maternal postnatal depression
timeFrame: At baseline prior to intervention
measure: Maternal postnatal depression
timeFrame: Immediately after intervention
measure: Maternal postnatal depression
timeFrame: At infant's corrected age of 3 months
measure: Maternal postnatal depression
timeFrame: At infant's corrected age of 6 months
measure: Parenting stress
timeFrame: At baseline prior to intervention
measure: Parenting stress
timeFrame: Immediately after intervention
measure: Parenting stress
timeFrame: At infant's corrected age of 3 months
measure: Parenting stress
timeFrame: At infant's corrected age of 6 months
measure: Infant's temperament
timeFrame: At baseline prior to intervention
measure: Infant's temperament
timeFrame: Immediately after intervention
measure: Infant's temperament
timeFrame: At infant's corrected age of 3 months
measure: Infant's temperament
timeFrame: At infant's corrected age of 6 months
measure: Infant's weight gain
timeFrame: At infant's corrected age of 3 months
measure: Infant's weight gain
timeFrame: At infant's corrected age of 6 months
measure: Infant's weight gain
timeFrame: At infant's corrected age of 9 months
measure: Infant's weight gain
timeFrame: At infant's corrected age of 12 months
measure: Infant's developmental outcomes
timeFrame: At infant's corrected age of 3 months
measure: Infant's developmental outcomes
timeFrame: At infant's corrected age of 6 months
measure: Infant's developmental outcomes
timeFrame: At infant's corrected age of 9 months
measure: Infant's developmental outcomes
timeFrame: At infant's corrected age of 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Terry Au, PhD
role: STUDY_DIRECTOR
References:
citation: Yu NKK, Shum KK, Lam YY, Kwan QKL, Ng SYP, Chan NTT. Sensitivity Training for Mothers With Premature Infants: A Randomized Controlled Trial. J Pediatr Psychol. 2022 Oct 19;47(10):1167-1184. doi: 10.1093/jpepsy/jsac051.