University of Hong Kong
Hong Kong
Completed
NCT Number: NCT04383340
Sensitivity Training for Parents With Premature Infants
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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)
Treatment and study plan
Mother-Infant Transaction Program
BehavioralParent sensitivity training for mothers of premature infants
Treatment as Usual
BehavioralStandard hospital care and parental support
Primary outcomes
-
Behavioral observation of mother-infant interactions
Time frame: At baseline prior to intervention
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.
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Behavioral observation of mother-infant interactions
Time frame: Immediately after intervention
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
Time frame: At infant's corrected age of 3 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.
-
Behavioral observation of mother-infant interactions
Time frame: 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.
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Maternal postnatal depression
Time frame: At baseline prior to intervention
Maternal depression measured by the Edinburgh Postnatal Depression Scale. Possible scores range from 0 to 30. Higher scores indicate higher levels of depression.
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Maternal postnatal depression
Time frame: Immediately after intervention
Maternal depression measured by the Edinburgh Postnatal Depression Scale. Possible scores range from 0 to 30. Higher scores indicate higher levels of depression.
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Maternal postnatal depression
Time frame: At infant's corrected age of 3 months
Maternal depression measured by the Edinburgh Postnatal Depression Scale. Possible scores range from 0 to 30. Higher scores indicate higher levels of depression.
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Maternal postnatal depression
Time frame: 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.
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Parenting stress
Time frame: At baseline prior to intervention
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.
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Parenting stress
Time frame: Immediately after intervention
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
Time frame: At infant's corrected age of 3 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.
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Parenting stress
Time frame: 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.
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Infant's temperament
Time frame: At baseline prior to intervention
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.
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Infant's temperament
Time frame: Immediately after intervention
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.
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Infant's temperament
Time frame: At infant's corrected age of 3 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.
-
Infant's temperament
Time frame: 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.
-
Infant's weight gain
Time frame: At infant's corrected age of 3 months
Infant's weight gain from birth
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Infant's weight gain
Time frame: At infant's corrected age of 6 months
Infant's weight gain from birth
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Infant's weight gain
Time frame: At infant's corrected age of 9 months
Infant's weight gain from birth
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Infant's weight gain
Time frame: At infant's corrected age of 12 months
Infant's weight gain from birth
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Infant's developmental outcomes
Time frame: At infant's corrected age of 3 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
-
Infant's developmental outcomes
Time frame: At infant's corrected age of 6 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
-
Infant's developmental outcomes
Time frame: At infant's corrected age of 9 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
-
Infant's developmental outcomes
Time frame: 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
Sponsors and collaborators
Lead sponsor
The University of Hong Kong
Other
Collaborators
- Hospital Authority, Hong Kong
Registry information
Official study title
Sensitivity Training for Mothers With Premature Infants: A Randomized Controlled Trial
Important dates
- Study start
- 2018
- Primary completion
- 2019
- Study completion
- 2019
- First posted
- May 12, 2020
- Registry last updated
- Apr 27, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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