Family ResilienceNCT07373002
Development and Evaluation of an Intelligent Parent-Infant Connection-Based Intervention to Strengthen Family Resilience in Preterm Infant Care
A study testing Intelligent Intervention to enhance Parent-Infant Connection and Family Resilience and Routine Care in people with Family Resilience and Parent-Infant Bonding, run by National Defense Medical Center, Taiwan.
Trial summary
This study aims to develop, optimize, and evaluate the effectiveness of a family resilience intervention centered on intelligent parent-infant connection for parents of preterm infants. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Family Resilience, Parent-Infant Bonding, Parents of Premature Infants
- What is being tested?
- Intelligent Intervention to enhance Parent-Infant Connection and Family Resilience and Routine Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 31 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The infant is born prematurely with a gestational age of less than 37 weeks.
- At least one parent of the premature infant is aged 18 years or older and can communicate in Mandarin or Taiwanese.
- The parent(s) have provided informed consent to participate in the study.
- The parent(s) are able to comply with the data collection procedures (participation of both parents is encouraged but not required).
Who cannot join
- The premature infant has major congenital anomalies or is assessed by clinicians as unlikely to survive.
- The parent(s) are unable to use a smartphone or internet-connected device due to technical, cognitive, or other limitations.
- The parent(s) have a known history of severe psychiatric disorders, intellectual disabilities, or substance abuse, and are assessed by the research team as being unable to comply with the study procedures or intervention requirements.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Development, Optimization, and Effectiveness Evaluation of an Intelligent Parent-Infant Connection-Based Family Resilience Intervention: A Longitudinal Study of Parental Psychosocial Health From Hospitalization to Post-Discharge in Preterm Infants
This study aims to develop, optimize, and evaluate the effectiveness of a family resilience intervention centered on intelligent parent-infant connection for parents of preterm infants. Using a longitudinal randomized controlled trial design, it examines the intervention's impact on parental psychosocial health, parenting efficacy, family resilience, and parent-infant interaction from NICU hospitalization to six months post-discharge.
Read the detailed description
This longitudinal randomized controlled trial evaluates a family resilience intervention centered on intelligent parent-infant connection, designed for parents of preterm infants hospitalized in the NICU. The study recruits approximately 150 dyads of preterm infants' parents over three years at Tri-Service General Hospital, Taiwan. The intervention group receives routine care plus a digitally delivered support program during hospitalization and the first month after discharge, while the control group receives routine clinical care only. The intervention comprises low-burden, accessible modules focusing on parent-infant interaction, caregiving competence, emotional support, and paternal involvement. Data are collected at five time points: baseline (within 1 week of NICU admission), pre-discharge, and one, three, and six months post-discharge. Outcomes include family resilience, parenting efficacy, parent-infant bonding, psychological stress, sleep quality, and biological stress indicators (salivary cortisol). The study aims to establish the intervention's effectiveness in improving the psychosocial well-being of preterm infants' parents and supporting family adaptation across care transitions.
- Conditions
- Family Resilience, Parent-Infant Bonding, Parents of Premature Infants, Intelligent Intervention
- Being tested
- Intelligent Intervention to enhance Parent-Infant Connection and Family Resilience, Routine Care
- Keywords
- Psychosocial Health, Digital Health Intervention, Salivary Cortisol, Neonatal Intensive Care Unit (NICU), Physical Health, Social Health, Mental Health, Family Resilience, Parent-Infant Bonding
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intelligent Intervention to enhance Parent-Infant Connection and Family ResilienceBehavioural
This is a structured, mobile-based behavioral intervention designed to support the psychosocial health and caregiving competence of parents with preterm infants during and after NICU hospitalization. The intervention includes educational modules, interactive messages, and self-guided activities delivered through a digital platform. Content is tailored to promote parent-infant bonding, enhance parenting confidence, strengthen family resilience, and reduce parenting stress. The intervention begins during the infant's NICU stay and continues for one month after discharge. Participants receive reminders, feedback, and supportive information based on their responses and needs, aiming to facilitate the transition from hospital to home and improve early parenting experiences.
Routine CareOther
Participants in this group will receive routine care as provided in the NICU and after discharge, including standard parent education and support without access to the digital intervention program. They will complete the same assessments as the experimental group across five time points from hospitalization to six months post-discharge.
| Study group | Role | What they receive |
|---|---|---|
| Intelligent Intervention to enhance Parent-Infant Connection and Family Resilience | Experimental | Participants in this group will receive routine care plus an intelligent parent-infant connection-based intervention. The intervention includes access to a mobile platform that delivers structured educational content focused on premature infant care, emotional regulation, parent-infant bonding, and stress management. The program begins during the infant's NICU hospitalization and continues for one month post-discharge. Participants will also receive interactive messages, tips, and guidance to support their caregiving role and psychosocial adjustment during the transition to home care. Receives: Behavioral: Intelligent Intervention to enhance Parent-Infant Connection and Family Resilience; Other: Routine Care |
| Routine care group | Active comparator | Participants in this group will receive routine care as provided in the NICU and after discharge, including standard parent education and support without access to the digital intervention program. They will complete the same assessments as the experimental group across five time points from hospitalization to six months post-discharge. Receives: Other: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Family Resilience
Family resilience will be measured using the Chinese version of the Walsh Family Resilience Questionnaire. This scale assesses key processes across three domains: family belief systems, organizational patterns, and communication/problem-solving. Each item is rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The total score is calculated by summing item scores, with higher scores indicating greater family resilience.
Measured: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
Change in Parent-Infant Bonding
Parent-infant bonding will be assessed using the Chinese version of the Postpartum Bonding Questionnaire (PBQ), which measures the parent's emotional connection to their infant, including feelings of affection, confidence, and potential rejection or anxiety. The scale includes 25 items rated on a 6-point scale from 0 (always) to 5 (never), with some items reverse scored. Total scores range from 0 to 125; lower scores indicate stronger parent-infant bonding, while higher scores suggest bonding difficulties.
Measured: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
Change in Perceived Stress
Perceived stress will be measured using the Chinese version of the 14-item Perceived Stress Scale (PSS-14). This scale assesses participants' subjective evaluation of stress in their lives during the past month. Each item is rated on a 5-point Likert scale from 0 (never) to 4 (very often). The total score ranges from 0 to 56, with higher scores indicating higher levels of perceived stress.
Measured: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
Change in Postpartum Specific Anxiety
Postpartum anxiety will be measured using the Chinese version of the Postpartum Specific Anxiety Scale - Research Short Form (PSAS-RSF-C). The scale includes 16 items evaluating anxiety related to infant care, maternal competence, psychosocial adjustment, and infant safety. Items are rated on a 4-point Likert scale from 1 (not at all) to 4 (very much). Total scores range from 16 to 64, with higher scores indicating greater postpartum-specific anxiety.
Measured: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
Change in Salivary Cortisol
Cortisol levels (in ng/mL) serve as a physiological biomarker for stress; higher levels indicate greater stress reactivity. Salivary cortisol levels will be collected using a non-invasive saliva collection method and analyzed using the SOMA real-time cortisol analysis system. Saliva samples will be collected at consistent times to control for diurnal variation.
Measured: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
Change in Family Hardiness
The Family Hardiness Index (FHI) assesses family resilience in response to stress and crisis. It consists of 20 items measuring three dimensions: commitment, control, and challenge. Each item is rated on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree), with items 1, 2, 3, 8, 10, 14, 16, 19, and 20 reverse scored. Total scores range from 20 to 80, with higher scores indicating greater family hardiness and stronger coping abilities.
Measured: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
Change in Maternal Postnatal Attachment
The Maternal Postnatal Attachment Scale (MPAS) evaluates the emotional quality of maternal attachment to the infant. It includes 19 items across three dimensions: quality of attachment, absence of hostility, and pleasure in interaction. Each item is re-coded to a uniform 5-point scale from 1 to 5, with some items reverse scored. Total scores range from 19 to 95, with higher scores reflecting stronger and more positive maternal attachment.
Measured: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
Change in Maternal Confidence
The Maternal Confidence Questionnaire assesses a mother's perceived confidence in parenting, particularly in the context of premature infants. The scale consists of 14 items rated on a 5-point Likert scale from 1 (never) to 5 (always), with items 12 and 14 reverse scored. Higher total scores indicate greater maternal confidence.
Measured: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
Change in Parental Role Adaptation
The Parental Role Adaptation Scale in Neonatal Intensive Care Units assesses mothers' adaptation to the maternal role during their infant's NICU stay. It consists of 32 items rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree), covering six domains: involvement in care (14 items), self-efficacy (6), remote motherhood (3), uncertainty (4), interaction (3), and growth and development (2). Higher scores indicate better adaptation to the maternal role.
Measured: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
Change in Functional Social Support
The Functional Social Support Scale measures caregivers' perceived social support across three dimensions: support needed, assistance received, and satisfaction. Each of the 16 items includes aspects of emotional, informational, and instrumental support. Responses are given on a 5-point Likert scale ranging from 0 (never) to 4 (always), or from 0 (not needed at all) to 4 (very much needed). Higher scores indicate stronger perceived support and fulfillment.
Measured: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
Secondary outcomes (5)
Change in Quality of Life
Measured using the Taiwan version of WHOQOL-BREF, which contains 26 items covering physical, psychological, social, and environmental domains. Each item is rated on a 5-point scale. Total scores are calculated and standardized to a 0-100 scale, with higher scores indicating better quality of life.
Measured: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
Change in Parental Self-Efficacy
Parental self-efficacy will be assessed using the Parental Self-Efficacy Scale (PSE), a 20-item instrument scored on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Scores range from 20 to 100. Higher scores indicate stronger parental confidence in caregiving roles.
Measured: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
Change in Subjective Sleep Quality
Evaluated using the Pittsburgh Sleep Quality Index (PSQI), which includes 19 items assessing sleep duration, latency, quality, and disturbances. Scores range from 0 to 21, with higher scores indicating worse sleep quality. A score >5 suggests poor sleep.
Measured: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
Change in Objective Sleep Indicators
Sleep duration and efficiency will be measured using the ActiGraph GT3X accelerometer, worn continuously on the non-dominant wrist for 72 hours. Data will be downloaded and analyzed to calculate total sleep time (minutes) and sleep efficiency (percentage of time asleep while in bed).
Measured: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
Change in Subjective Sleep Quality and Parameter (Sleep Diary)
This self-developed sleep diary was designed to capture sleep quality, patterns, and disturbances over a continuous 3-day period. Each morning upon waking, participants recorded their recall of the previous night's sleep, including total sleep time (in hours), number and duration of nighttime awakenings, and perceived sleep efficiency. They also noted contextual factors that may have affected their sleep, such as emotional distress, physical discomfort, medication use, or consumption of stimulants or alcohol. In addition, participants rated their perceived sleep quality and level of alertness upon waking using a 5-point Likert scale, where 1 indicated the poorest quality or alertness and 5 indicated the highest. Higher scores reflect better subjective sleep outcomes.
Measured: At baseline (before intervention),1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family ResilienceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsiang-Yun Lan, National Defense Medical Center, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07373002
- Sponsor's protocol ID
- T-NDMU-67611
- Status last verified
- Jul 2026
- First submitted
- 13 Jan 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development, Optimization, and Effectiveness Evaluation of an Intelligent Parent-Infant Connection-Based Family Resilience Intervention: A Longitudinal Study of Parental Psychosocial Health From Hospitalization to Post-Discharge in Preterm Infants
- ClinicalTrials.gov ID
- NCT07373002
- Acronym / sponsor ID
- T-NDMU-67611
- Conditions
- Family Resilience, Parent-Infant Bonding, Parents of Premature Infants, Intelligent Intervention
- Keywords
- Psychosocial Health, Digital Health Intervention, Salivary Cortisol, Neonatal Intensive Care Unit (NICU), Physical Health, Social Health, Mental Health, Family Resilience
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to develop, optimize, and evaluate the effectiveness of a family resilience intervention centered on intelligent parent-infant connection for parents of preterm infants. Using a longitudinal randomized controlled trial design, it examines the intervention's impact on parental psychosocial health, parenting efficacy, family resilience, and parent-infant interaction from NICU hospitalization to six months post-discharge.
Detailed description
This longitudinal randomized controlled trial evaluates a family resilience intervention centered on intelligent parent-infant connection, designed for parents of preterm infants hospitalized in the NICU. The study recruits approximately 150 dyads of preterm infants' parents over three years at Tri-Service General Hospital, Taiwan. The intervention group receives routine care plus a digitally delivered support program during hospitalization and the first month after discharge, while the control group receives routine clinical care only. The intervention comprises low-burden, accessible modules focusing on parent-infant interaction, caregiving competence, emotional support, and paternal involvement. Data are collected at five time points: baseline (within 1 week of NICU admission), pre-discharge, and one, three, and six months post-discharge. Outcomes include family resilience, parenting efficacy, parent-infant bonding, psychological stress, sleep quality, and biological stress indicators (salivary cortisol). The study aims to establish the intervention's effectiveness in improving the psychosocial well-being of preterm infants' parents and supporting family adaptation across care transitions.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intelligent Intervention to enhance Parent-Infant Connection and Family Resilience | Experimental | Behavioral: Intelligent Intervention to enhance Parent-Infant Connection and Family Resilience, Other: Routine CareParticipants in this group will receive routine care plus an intelligent parent-infant connection-based intervention. The intervention includes access to a mobile platform that delivers structured educational content focused on premature infant care, emotional regulation, parent-infant bonding, and stress management. The program begins during the infant's NICU hospitalization and continues for one month post-discharge. Participants will also receive interactive messages, tips, and guidance to support their caregiving role and psychosocial adjustment during the transition to home care. |
| Routine care group | Active comparator | Other: Routine CareParticipants in this group will receive routine care as provided in the NICU and after discharge, including standard parent education and support without access to the digital intervention program. They will complete the same assessments as the experimental group across five time points from hospitalization to six months post-discharge. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The infant is born prematurely with a gestational age of less than 37 weeks.
- At least one parent of the premature infant is aged 18 years or older and can communicate in Mandarin or Taiwanese.
- The parent(s) have provided informed consent to participate in the study.
- The parent(s) are able to comply with the data collection procedures (participation of both parents is encouraged but not required).
Key exclusion criteria (3 listed)
- The premature infant has major congenital anomalies or is assessed by clinicians as unlikely to survive.
- The parent(s) are unable to use a smartphone or internet-connected device due to technical, cognitive, or other limitations.
- The parent(s) have a known history of severe psychiatric disorders, intellectual disabilities, or substance abuse, and are assessed by the research team as being unable to comply with the study procedures or intervention requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intelligent Intervention to enhance Parent-Infant Connection and Family ResilienceThis is a structured, mobile-based behavioral intervention designed to support the psychosocial health and caregiving competence of parents with preterm infants during and after NICU hospitalization. The intervention includes educational modules, interactive messages, and self-guided activities delivered through a digital platform. Content is tailored to promote parent-infant bonding, enhance parenting confidence, strengthen family resilience, and reduce parenting stress. The intervention begins during the infant's NICU stay and continues for one month after discharge. Participants receive reminders, feedback, and supportive information based on their responses and needs, aiming to facilitate the transition from hospital to home and improve early parenting experiences. | Behavioural | Intelligent Intervention to enhance Parent-Infant Connection and Family Resilience |
| Routine CareParticipants in this group will receive routine care as provided in the NICU and after discharge, including standard parent education and support without access to the digital intervention program. They will complete the same assessments as the experimental group across five time points from hospitalization to six months post-discharge. | Other | Intelligent Intervention to enhance Parent-Infant Connection and Family Resilience, Routine care group |
Primary outcome
Change in Family Resilience
Time frame: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
Family resilience will be measured using the Chinese version of the Walsh Family Resilience Questionnaire. This scale assesses key processes across three domains: family belief systems, organizational patterns, and communication/problem-solving. Each item is rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The total score is calculated by summing item scores, with higher scores indicating greater family resilience.
Change in Parent-Infant Bonding
Time frame: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
Parent-infant bonding will be assessed using the Chinese version of the Postpartum Bonding Questionnaire (PBQ), which measures the parent's emotional connection to their infant, including feelings of affection, confidence, and potential rejection or anxiety. The scale includes 25 items rated on a 6-point scale from 0 (always) to 5 (never), with some items reverse scored. Total scores range from 0 to 125; lower scores indicate stronger parent-infant bonding, while higher scores suggest bonding difficulties.
Change in Perceived Stress
Time frame: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
Perceived stress will be measured using the Chinese version of the 14-item Perceived Stress Scale (PSS-14). This scale assesses participants' subjective evaluation of stress in their lives during the past month. Each item is rated on a 5-point Likert scale from 0 (never) to 4 (very often). The total score ranges from 0 to 56, with higher scores indicating higher levels of perceived stress.
Change in Postpartum Specific Anxiety
Time frame: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
Postpartum anxiety will be measured using the Chinese version of the Postpartum Specific Anxiety Scale - Research Short Form (PSAS-RSF-C). The scale includes 16 items evaluating anxiety related to infant care, maternal competence, psychosocial adjustment, and infant safety. Items are rated on a 4-point Likert scale from 1 (not at all) to 4 (very much). Total scores range from 16 to 64, with higher scores indicating greater postpartum-specific anxiety.
Change in Salivary Cortisol
Time frame: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
Cortisol levels (in ng/mL) serve as a physiological biomarker for stress; higher levels indicate greater stress reactivity. Salivary cortisol levels will be collected using a non-invasive saliva collection method and analyzed using the SOMA real-time cortisol analysis system. Saliva samples will be collected at consistent times to control for diurnal variation.
Change in Family Hardiness
Time frame: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
The Family Hardiness Index (FHI) assesses family resilience in response to stress and crisis. It consists of 20 items measuring three dimensions: commitment, control, and challenge. Each item is rated on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree), with items 1, 2, 3, 8, 10, 14, 16, 19, and 20 reverse scored. Total scores range from 20 to 80, with higher scores indicating greater family hardiness and stronger coping abilities.
Change in Maternal Postnatal Attachment
Time frame: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
The Maternal Postnatal Attachment Scale (MPAS) evaluates the emotional quality of maternal attachment to the infant. It includes 19 items across three dimensions: quality of attachment, absence of hostility, and pleasure in interaction. Each item is re-coded to a uniform 5-point scale from 1 to 5, with some items reverse scored. Total scores range from 19 to 95, with higher scores reflecting stronger and more positive maternal attachment.
Change in Maternal Confidence
Time frame: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
The Maternal Confidence Questionnaire assesses a mother's perceived confidence in parenting, particularly in the context of premature infants. The scale consists of 14 items rated on a 5-point Likert scale from 1 (never) to 5 (always), with items 12 and 14 reverse scored. Higher total scores indicate greater maternal confidence.
Change in Parental Role Adaptation
Time frame: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
The Parental Role Adaptation Scale in Neonatal Intensive Care Units assesses mothers' adaptation to the maternal role during their infant's NICU stay. It consists of 32 items rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree), covering six domains: involvement in care (14 items), self-efficacy (6), remote motherhood (3), uncertainty (4), interaction (3), and growth and development (2). Higher scores indicate better adaptation to the maternal role.
Change in Functional Social Support
Time frame: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
The Functional Social Support Scale measures caregivers' perceived social support across three dimensions: support needed, assistance received, and satisfaction. Each of the 16 items includes aspects of emotional, informational, and instrumental support. Responses are given on a 5-point Likert scale ranging from 0 (never) to 4 (always), or from 0 (not needed at all) to 4 (very much needed). Higher scores indicate stronger perceived support and fulfillment.
5 secondary outcomes
Change in Quality of Life
Time frame: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
Change in Parental Self-Efficacy
Time frame: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
Change in Subjective Sleep Quality
Time frame: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
Change in Objective Sleep Indicators
Time frame: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
Change in Subjective Sleep Quality and Parameter (Sleep Diary)
Time frame: At baseline (before intervention),1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Intelligent Intervention to enhance Parent-Infant Connection and Family Resilience and Routine Care in people with Family Resilience and Parent-Infant Bonding, run by National Defense Medical Center, 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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lan Hsiang-Yun, A.P. (+886287923100 Ext. 18781, shinnylan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Family Resilience (time frame: At baseline (before intervention), 1 month after birth, and at 1 month, 3 months, and 6 months post-discharge.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2026; AzTrials last refreshed its copy on 2 Nov 2026.