Sensitivity Training for Parents With Premature Infants

NCT ID: NCT04383340

Last Updated: 2022-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2019-08-31

Brief Summary

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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

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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.

Conditions

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Premature Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
All individual assessments were conducted by a clinical psychologist at the hospital who was blinded to the experimental condition of the participants.

Study Groups

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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.

Group Type EXPERIMENTAL

Mother-Infant Transaction Program

Intervention Type BEHAVIORAL

Parent sensitivity training for mothers of premature infants

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

Group Type ACTIVE_COMPARATOR

Treatment as usual

Intervention Type BEHAVIORAL

Standard hospital care and parental support

Interventions

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Mother-Infant Transaction Program

Parent sensitivity training for mothers of premature infants

Intervention Type BEHAVIORAL

Treatment as usual

Standard hospital care and parental support

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Authority, Hong Kong

OTHER_GOV

Sponsor Role collaborator

The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Terry Au, PhD

Role: STUDY_DIRECTOR

The University of Hong Kong

Locations

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University of Hong Kong

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

References

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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.

Reference Type DERIVED
PMID: 35666133 (View on PubMed)

Other Identifiers

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KCC/RC/G/1819-B03

Identifier Type: -

Identifier Source: org_study_id

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