Sensitivity Training for Parents With Premature Infants

Premature Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04383340
• Other study ID #: KCC/RC/G/1819-B03
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: August 31, 2019

Study information

• Verified date: May 2020
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hypersensitivity
• Premature Birth

Intervention

Behavioral:
• Mother-Infant Transaction Program
Parent sensitivity training for mothers of premature infants
• Treatment as usual
Standard hospital care and parental support

Locations

Country	Name	City	State
Hong Kong	University of Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Hospital Authority, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Infant's weight gain	Infant's weight gain from birth	At infant's corrected age of 3 months
Primary	Infant's weight gain	Infant's weight gain from birth	At infant's corrected age of 6 months
Primary	Infant's weight gain	Infant's weight gain from birth	At infant's corrected age of 9 months
Primary	Infant's weight gain	Infant's weight gain from birth	At infant's corrected age of 12 months
Primary	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
Primary	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
Primary	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
Primary	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