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AttachmentNCT05302700

Effectiveness of Early Parental Sensitivity Intervention for Preterm Infant Mothers

A study testing Early Parental Sensitivity Intervention in people with Attachment and Parental Stress, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In Taiwan, according to the birth notification statistics of the Ministry of Health and Welfare. 164,496 newborns were born in 2020, with preterm births accounting for about 11.58%.Most preterm infants need to be hospitalized for highly specialized care, resulting in the separation of preterm infants from their… Read more about this study

Who is it for?
Ages 20 to 55 years, women only
Conditions the study is for
Attachment, Parental Stress
What is being tested?
Early Parental Sensitivity Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteTaiwan
Study dates
2 Nov 2022to 22 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 55 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Preterm infants:
  • Preterm infants less than 37 weeks gestation and hospitalized in the NICU
  • The birth weight is classified as VLBW and LBW, and the birth weight is between 1,000-2,499gm
  • Preterm infant mothers:
  • Children have not been hospitalized in the NICU in the past
  • At least 20 years old
  • They can speak Chinese, Taiwanese fluently and need to be literate

Who cannot join

  • Preterm infants :
  • Combined congenital diseases and chromosomal abnormalities
  • Immediate surgery, first aid and unstable vital signs are necessary after birth
  • The birth weight is classified as ELBW, and the birth weight is less than 1,000gm
  • Preterm infant mothers:
  • Hospitalized in the intensive care unit

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Yang Ming Chiao Tung University

    Taipei, 11221

Other trials in Taiwan

About this study

Official title: The Effectiveness of Early Parental Sensitivity Intervention on Attachment, Parenting Confidence and Parental Stress of Preterm Infant Mothers

In Taiwan, according to the birth notification statistics of the Ministry of Health and Welfare. 164,496 newborns were born in 2020, with preterm births accounting for about 11.58%.Most preterm infants need to be hospitalized for highly specialized care, resulting in the separation of preterm infants from their parents after birth, which may have a negative impact on the healthy attachment development between parents and preterm infants. Moreover, due to the vulnerability of preterm infants, parents often lack the confidence to take care of them.

Read the detailed description

The study was a quantitative study of a randomized controlled trial, designed by experimental research method. Using GPower 3.1.2 to estimate the number of samples, and the statistical method chosen was Repeated measures ANOVA, the sample size was 80.

The subjects were divided into two groups, The control group received general routine nursing guidance, while the experimental group received general routine nursing guidance and early parental sensitivity intervention program. Using the NICU VR Tour and Premature Infant Behavioral Clues Teaching Materials as educational tools for early parental sensitivity intervention program. The outcome used the Maternal Attachment Inventory, Maternal Confidence Questionnaire and Parental Stressor Scale: Infant Hospitalization as evaluated tools.

Being tested
Early Parental Sensitivity Intervention
Keywords
preterm infant mothers, early, parental sensitivity intervention, attachment, parenting confidence, parental stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early Parental Sensitivity InterventionBehavioural

    Parental sensitivity intervention include (1)Establish an emotional connection：Using the VR tour to introduce the environment, instruments and equipment of the neonatal intensive care unit, appearance of premature infants and pipeline wires on their bodies .(2)maintain physical proximity:proactively provide mothers with the opportunity to touch the body of preterm infants.(3) parents must understand their infant's cues:Using the Premature Infant Behavioral Clues Teaching Materials to play video and we will discuss and respond to the mother's questions.(4)engage in his/her care and communicate appropriately with him/her:We will discuss the behavioral clues of the preterm infant with the mother next to the incubator, encourage the mother to ask questions and participate in care activities such as changing diapers and stamping the baby's footprints on the card, asking the mother to write down the number of days of birth, corrected age, weight and what she wants to say for her baby.

Study groups in NCT05302700
Study groupRoleWhat they receive
Early Parental Sensitivity Intervention ProgramExperimentalThe protocol will last five to seven days for preterm infant mothers.
Receives: Behavioral: Early Parental Sensitivity Intervention
Control groupNo interventionThe control group received general routine nursing guidance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maternal Attachment Inventory

    Using the Maternal Attachment Inventory to measure mother-infant attachment.There are 22 items on the scale,each item was scored using a 4-point Likert scale.The total score ranges from 22 to 88, with higher scores indicating better attachment.

    Measured: On the fifth to seventh day after birth of preterm infant.

  2. Maternal Confidence Questionnaire

    Using the Maternal Confidence Questionnaire to measure parenting confidence.There are 14 items on the scale,each item was scored using a 5-point Likert scale.The total score ranges from 14 to 70, with higher scores indicating better parenting confidence.

    Measured: On the fifth to seventh day after birth of preterm infant.

  3. Parental Stressor Scale: Infant Hospitalization

    Using the Parental Stressor Scale: Infant Hospitalization to measure parental stress.There are 21 items on the scale,each item was scored using a 5-point Likert scale.The total score ranges from 21 to 105, with higher scores indicating greater stress.

    Measured: On the fifth to seventh day after birth of preterm infant.

Secondary outcomes (3)

  1. Maternal Attachment Inventory

    Using the Maternal Attachment Inventory to measure mother-infant attachment.There are 22 items on the scale,each item was scored using a 4-point Likert scale.The total score ranges from 22 to 88, with higher scores indicating better attachment.

    Measured: The first month of birth of preterm infant.

  2. Maternal Confidence Questionnaire

    Using the Maternal Confidence Questionnaire to measure parenting confidence.There are 14 items on the scale,each item was scored using a 5-point Likert scale.The total score ranges from 14 to 70, with higher scores indicating better parenting confidence.

    Measured: The first month of birth of preterm infant.

  3. Parental Stressor Scale: Infant Hospitalization

    Using the Parental Stressor Scale: Infant Hospitalization to measure parental stress.There are 21 items on the scale,each item was scored using a 5-point Likert scale.The total score ranges from 21 to 105, with higher scores indicating greater stress.

    Measured: The first month of birth of preterm infant.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2022
  2. Study start2 Nov 2022
  3. Primary completion20 Sep 2023
  4. Study completion22 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05302700
Sponsor's protocol ID
Y_110_0501
Status last verified
Mar 2023
First submitted
15 Mar 2022
Last updated
9 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lavallee A, Aita M, Bourbonnais A, De Clifford-Faugere G. Effectiveness of early interventions for parental sensitivity following preterm birth: a systematic review protocol. Syst Rev. 2017 Mar 23;6(1):62. doi: 10.1186/s13643-017-0459-x.

    PubMed 28335806

  • Dunham MM, Marin T. NICU Maternal-Infant Bonding: Virtual Visitation as a Bonding Enhancement Tool. J Perinat Neonatal Nurs. 2020 Apr/Jun;34(2):171-177. doi: 10.1097/JPN.0000000000000484.

    PubMed 32332447

  • Ioannou A, Papastavrou E, Avraamides MN, Charalambous A. Virtual Reality and Symptoms Management of Anxiety, Depression, Fatigue, and Pain: A Systematic Review. SAGE Open Nurs. 2020 Aug 27;6:2377960820936163. doi: 10.1177/2377960820936163. eCollection 2020 Jan-Dec.

    PubMed 33415290

  • Kim AR, Kim SY, Yun JE. Attachment and relationship-based interventions for families during neonatal intensive care hospitalization: a study protocol for a systematic review and meta-analysis. Syst Rev. 2020 Mar 21;9(1):61. doi: 10.1186/s13643-020-01331-8.

    PubMed 32199458

Questions about this trial

What is this clinical trial studying?

A study testing Early Parental Sensitivity Intervention in people with Attachment and Parental Stress, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maternal Attachment Inventory (time frame: On the fifth to seventh day after birth of preterm infant.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05302700, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.

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