Sensitivity Training for Parents With Premature Infants

Sensitivity Training for Mothers With Premature Infants: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Premature Birth
• Intervention / Treatment: Behavioral: Mother-Infant Transaction Program; Behavioral: Treatment as usual

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 Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Mother-Infant Transaction Program; Four sessions were delivered to the mothers one-on-one based on a manualized protocol while the infants were still in the neonatal intensive care units. These coaching sessions included psychological care for the mother and topics on recognizing premature infant's characteristics, understanding and recognizing signs of infant stress and infant's engagement and disengagement cues, principles of graded stimulation, and how to optimize interactions and avoid over-stimulating the infant.	Behavioral: Mother-Infant Transaction Program; Parent sensitivity training for mothers of premature infants
ACTIVE_COMPARATOR: Treatment as usual; For this group, infants and mothers received standard hospital care following the initial baseline assessment; these mothers were invited to ask questions about recommended ways to take care of their infants, but no specific knowledge or skills targeted by the adapted MITP program were taught	Behavioral: Treatment as usual; Standard hospital care and parental support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavioral observation of mother-infant interactions	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.	At baseline prior to intervention
Behavioral observation of mother-infant interactions	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.	Immediately after intervention
Behavioral observation of mother-infant interactions	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.	At infant's corrected age of 3 months
Behavioral observation of mother-infant interactions	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.	At infant's corrected age of 6 months
Maternal postnatal depression	Maternal depression measured by the Edinburgh Postnatal Depression Scale. Possible scores range from 0 to 30. Higher scores indicate higher levels of depression.	At baseline prior to intervention
Maternal postnatal depression	Maternal depression measured by the Edinburgh Postnatal Depression Scale. Possible scores range from 0 to 30. Higher scores indicate higher levels of depression.	Immediately after intervention
Maternal postnatal depression	Maternal depression measured by the Edinburgh Postnatal Depression Scale. Possible scores range from 0 to 30. Higher scores indicate higher levels of depression.	At infant's corrected age of 3 months
Maternal postnatal depression	Maternal depression measured by the Edinburgh Postnatal Depression Scale. Possible scores range from 0 to 30. Higher scores indicate higher levels of depression.	At infant's corrected age of 6 months
Parenting stress	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.	At baseline prior to intervention
Parenting stress	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.	Immediately after intervention
Parenting stress	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.	At infant's corrected age of 3 months
Parenting stress	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.	At infant's corrected age of 6 months
Infant's temperament	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.	At baseline prior to intervention
Infant's temperament	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.	Immediately after intervention
Infant's temperament	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.	At infant's corrected age of 3 months
Infant's temperament	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.	At infant's corrected age of 6 months
Infant's weight gain	Infant's weight gain from birth	At infant's corrected age of 3 months
Infant's weight gain	Infant's weight gain from birth	At infant's corrected age of 6 months
Infant's weight gain	Infant's weight gain from birth	At infant's corrected age of 9 months
Infant's weight gain	Infant's weight gain from birth	At infant's corrected age of 12 months
Infant's developmental outcomes	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	At infant's corrected age of 3 months
Infant's developmental outcomes	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	At infant's corrected age of 6 months
Infant's developmental outcomes	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	At infant's corrected age of 9 months
Infant's developmental outcomes	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	At infant's corrected age of 12 months

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: Hospital Authority, Hong Kong
• Investigators: Study Director: Terry Au, PhD, The University of Hong Kong

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2018
• Primary Completion (ACTUAL): August 31, 2019
• Study Completion (ACTUAL): August 31, 2019

Study Registration Dates

• First Submitted: May 5, 2020
• First Submitted That Met QC Criteria: May 6, 2020
• First Posted (ACTUAL): May 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: mother-infant interaction; sensitivity training
• Additional Relevant MeSH Terms: Immune System Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Hypersensitivity; Premature Birth
• Other Study ID Numbers: KCC/RC/G/1819-B03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication.
• IPD Sharing Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No