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Sensitivity Training for Parents With Premature Infants

Primary Purpose

Premature Birth

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Mother-Infant Transaction Program
Treatment as usual
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Premature Birth focused on measuring sensitivity training, mother-infant interaction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mother-Infant Transaction Program

Treatment as usual

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Infant's weight gain
Infant's weight gain from birth
Infant's weight gain
Infant's weight gain from birth
Infant's weight gain
Infant's weight gain from birth
Infant's weight gain
Infant's weight gain from birth
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
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
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
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

Secondary Outcome Measures

Full Information

First Posted
May 5, 2020
Last Updated
April 19, 2022
Sponsor
The University of Hong Kong
Collaborators
Hospital Authority, Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04383340
Brief Title
Sensitivity Training for Parents With Premature Infants
Official Title
Sensitivity Training for Mothers With Premature Infants: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
August 31, 2019 (Actual)
Study Completion Date
August 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong
Collaborators
Hospital Authority, Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth
Keywords
sensitivity training, mother-infant interaction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Outcomes Assessor
Masking Description
All individual assessments were conducted by a clinical psychologist at the hospital who was blinded to the experimental condition of the participants.
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mother-Infant Transaction Program
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Mother-Infant Transaction Program
Intervention Description
Parent sensitivity training for mothers of premature infants
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Intervention Description
Standard hospital care and parental support
Primary Outcome Measure Information:
Title
Behavioral observation of mother-infant interactions
Description
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.
Time Frame
At baseline prior to intervention
Title
Behavioral observation of mother-infant interactions
Description
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.
Time Frame
Immediately after intervention
Title
Behavioral observation of mother-infant interactions
Description
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.
Time Frame
At infant's corrected age of 3 months
Title
Behavioral observation of mother-infant interactions
Description
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.
Time Frame
At infant's corrected age of 6 months
Title
Maternal postnatal depression
Description
Maternal depression measured by the Edinburgh Postnatal Depression Scale. Possible scores range from 0 to 30. Higher scores indicate higher levels of depression.
Time Frame
At baseline prior to intervention
Title
Maternal postnatal depression
Description
Maternal depression measured by the Edinburgh Postnatal Depression Scale. Possible scores range from 0 to 30. Higher scores indicate higher levels of depression.
Time Frame
Immediately after intervention
Title
Maternal postnatal depression
Description
Maternal depression measured by the Edinburgh Postnatal Depression Scale. Possible scores range from 0 to 30. Higher scores indicate higher levels of depression.
Time Frame
At infant's corrected age of 3 months
Title
Maternal postnatal depression
Description
Maternal depression measured by the Edinburgh Postnatal Depression Scale. Possible scores range from 0 to 30. Higher scores indicate higher levels of depression.
Time Frame
At infant's corrected age of 6 months
Title
Parenting stress
Description
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.
Time Frame
At baseline prior to intervention
Title
Parenting stress
Description
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.
Time Frame
Immediately after intervention
Title
Parenting stress
Description
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.
Time Frame
At infant's corrected age of 3 months
Title
Parenting stress
Description
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.
Time Frame
At infant's corrected age of 6 months
Title
Infant's temperament
Description
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.
Time Frame
At baseline prior to intervention
Title
Infant's temperament
Description
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.
Time Frame
Immediately after intervention
Title
Infant's temperament
Description
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.
Time Frame
At infant's corrected age of 3 months
Title
Infant's temperament
Description
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.
Time Frame
At infant's corrected age of 6 months
Title
Infant's weight gain
Description
Infant's weight gain from birth
Time Frame
At infant's corrected age of 3 months
Title
Infant's weight gain
Description
Infant's weight gain from birth
Time Frame
At infant's corrected age of 6 months
Title
Infant's weight gain
Description
Infant's weight gain from birth
Time Frame
At infant's corrected age of 9 months
Title
Infant's weight gain
Description
Infant's weight gain from birth
Time Frame
At infant's corrected age of 12 months
Title
Infant's developmental outcomes
Description
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
Time Frame
At infant's corrected age of 3 months
Title
Infant's developmental outcomes
Description
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
Time Frame
At infant's corrected age of 6 months
Title
Infant's developmental outcomes
Description
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
Time Frame
At infant's corrected age of 9 months
Title
Infant's developmental outcomes
Description
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
Time Frame
At infant's corrected age of 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terry Au, PhD
Organizational Affiliation
The University of Hong Kong
Official's Role
Study Director
Facility Information:
Facility Name
University of Hong Kong
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
35666133
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.
Results Reference
derived

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Sensitivity Training for Parents With Premature Infants

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