Efficacy of Parent-child Sleep Intervention

NCT06143917 | Completed

• 1 other identifier: 2023-10-012C
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Parents of healthy neonates commonly face sleep disruptions and disturbances after delivery. Notably, increasing challenges are evident among parents of ill infants who required clinical care after birth . These challenges can adversely affect psychological adaptation and parental efficacy which consequently impacting the infant's development. It is crucial to develop an effective parent-child sleep intervention for improving parent-infant sleep and mental well-being and uneventful family health outcomes. Aim: To develop and evaluate the effects of parent-child sleep intervention on improving sleep quality, psychological health, and infant health in parents of infants at intermediate care nursery. Methods: A randomized controlled trial will be conducted at the intermediate care nursery of a level III medical center at Taipei city. A total of 102 pairs of parents and infants will be recruited and randomly assigned to the experimental group or the control group. The intervention program consists of (1) parent-child sleep education, (2) heart rate variability biofeedback training, and (3) counseling and support. Data collection will be multiple time points, including baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum. Anticipated results: Developing and evaluating a parent-child sleep intervention for postpartum parents and their infants. The findings will be an empirical evidence for pediatric care and family health promotion.

Conditions

Sleep Quality; Psychological Health; Infant Health

Keywords

Parents; Neonate; Sleep education; Sleep quality; Psychological health; Infant health

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in insomnia severity on the Chinese Version of the Insomnia Severity Index (ISI-C) at 1 month postpartum, 3 months postpartum, and 6 months postpartum

  The ISI is a validated, self-reported questionnaire assessing insomnia severity over the past month period. Possible scores range from 0 (absence of insomnia) to 28 (severe insomnia).

  Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum

Secondary Outcomes (8)

• Change from Baseline in sleep quality on the Chinese Version of the Pittsburgh sleep quality index (PSQI-C) at 1 month postpartum, 3 months postpartum, and 6 months postpartum

  Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum

• Change from Baseline in infant sleep quality on the Chinese Version of the Brief Infant Sleep Questionnaire-Revised Revised Short Form (BISQ-R-C SF) at 1 month postpartum, 3 months postpartum, and 6 months postpartum

  Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum

• Change from Baseline in anxiety symptoms on the Chinese Version of State-Trait Anxiety Inventory (STAI-C) at 1 month postpartum, 3 months postpartum, and 6 months postpartum

  Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum

• Change from Baseline in parenting efficacy and satisfaction on the Chinese Version of the Parenting Sense of Competence Scale (PSOC-C) at 1 month postpartum, 3 months postpartum, and 6 months postpartum

  Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum

• Infant health outcome

  Baseline, 1 month postpartum, 3 months postpartum, and 6 months postpartum

Study Arms (2)

parent-child sleep intervention

EXPERIMENTAL

Participants in the intervention will receive both the standardized usual care and parent-child sleep education, heart rate variability biofeedback training, and counseling and support.

Behavioral: parent-child sleep intervention

Control

NO INTERVENTION

Participants in the control group will receive attention from the research nurse and the standardized usual care.

Interventions

parent-child sleep intervention BEHAVIORAL

The intervention plan is as follows: (1) Parent-child sleep education includes two in-person session and four pre-recorded online sessions. Additionally, it provides educational handbooks tailored to the course content, segmented into sections for both parents and newborns. Each session lasts approximately 20 minutes; (2) Heart rate variability measurement and Heart rate variability biofeedback are conducted in classes in person. It guides parents through breathing exercises to activate the parasympathetic nervous system, thereby easing emotions and improving psychological health; (3) Professional counseling and support are provided separately at two weeks, one month, three months, and six months postpartum.

parent-child sleep intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Postpartum women aged 18 years or older.
• Postpartum women with a singleton pregnancy, and the gestational age of their infant is at least 32 weeks.
• Postpartum women with a severe insomnia severity index score of ≥8 points.
• Postpartum women and their husbands or partners capable of reading, understanding, and communicating in Mandarin.
• Postpartum women and their husbands or partners with internet access and the ability to operate resources using a smartphone, tablet, or computer.
• Both postpartum women and their husbands or partners are willing to participate in the research process.

You may not qualify if:

• Postpartum women diagnosed with Insomnia Disorder, Anxiety Disorders, or Depression.
• Postpartum women suffering from arrhythmia or cardiovascular diseases.
• Postpartum women working in shifts.
• Infants with congenital abnormalities, neurological impairments (such as hydrocephalus, periventricular leukomalacia), requiring the use of tubes or respirators after discharge, or using medications that might affect sleep (such as caffeine, sedatives, muscle relaxant, anti-epileptic drugs, or pain medications).

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Personal Satisfaction; Behavior

Study Officials

• Chien-Hui Chan

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: November 22, 2023
• Study Start: February 20, 2024
• Primary Completion: May 24, 2025
• Study Completion: May 24, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

TW (1)