Sensitivity Training for Parents With Premature Infants

NCT04383340 | Completed

• 1 other identifier: KCC/RC/G/1819-B03
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth

Keywords

sensitivity training; mother-infant interaction

Outcome Measures

Primary Outcomes (24)

• 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

Study Arms (2)

Mother-Infant Transaction Program

EXPERIMENTAL

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

Treatment as usual

ACTIVE COMPARATOR

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

Interventions

Mother-Infant Transaction Program BEHAVIORAL

Parent sensitivity training for mothers of premature infants

Mother-Infant Transaction Program

Treatment as usual BEHAVIORAL

Standard hospital care and parental support

Treatment as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mothers with premature infants born at 36 weeks or earlier

You may not qualify if:

• 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)

Sponsors & Collaborators

• The University of Hong Kong: lead
• Hospital Authority, Hong Kong: collaborator

Study Sites (1)

University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 35666133 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Terry Au, PhD

  The University of Hong Kong

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All individual assessments were conducted by a clinical psychologist at the hospital who was blinded to the experimental condition of the participants.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 12, 2020
• Study Start: February 1, 2018
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: April 27, 2022

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.

Locations

HK (1)