Clinical trial NCT06769841: Parent-Related Factors Associated with Sleep in Young Children
Official title: Parent-Related Factors Associated with Sleep in Young Children
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Child Sleep
Parenting
Parent-child Relations
Keywords: sleep
parent
infant
Lead sponsor: Marmara University
Sponsor class: OTHER
Collaborators: name: E-BEBEK Retail Joint Stock Company
First posted: 2025-01-10
Enrollment: 475
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy pregnant women aged 18 and above and their partners

Brief summary: Sleep plays a crucial role in supporting a child's healthy development, growth, and overall well-being. While many children develop healthy sleep patterns, 20-30% of infants experience sleep problems. Beyond biological processes, sleep is influenced by environmental, psychosocial, and cultural factors.

Understanding the relationship between parental factors and child sleep-wake patterns, alongside identifying potential developmental shifts during this period, is essential. However, existing research, often limited to cross-sectional or short-term longitudinal studies, has mostly focused on mothers, with few studies considering the transactional nature between infants' sleep patterns and the bidirectional influences exerted by other important parental factors.

This longitudinal study aims to understand how parent-infant interactions influence infant sleep patterns across the first three years of life for both mothers and fathers. The study will further examine the effects of parental factors, including (1) the co-parenting relationship, (2) maternal self-efficacy, (3) maternal/paternal depression, (4) maternal/paternal anxiety, (5) paternal involvement, (6) maternal/paternal sleep, and (7) parental stress, along with child factors such as temperament and socio-emotional development, on infants' sleep-wake patterns. Additionally, this study will investigate the dynamic, bidirectional relationships between these factors, providing valuable insights into infant and family well-being.

Detailed description: Sleep is a physiological process for a child's healthy development, growth, and well-being. Although child sleep regulation across the early years proceeds well for many, estimates of sleep problems among infants range between 20-30%.

Beyond biological processes, sleep is influenced by environmental, psychosocial, and cultural factors. According to the transactional model, infant sleep is shaped through a bidirectional, continuous, and complex relationship between internal factors related to the infant (such as temperament) and factors related to the parents (such as parental mental health, sleep-related behaviors, and the quality of their relationship with the child). Cultural factors also play a significant role in shaping children's sleep patterns, influencing both their sleep habits and parents' approaches to addressing sleep issues. Understanding how parental factors and child sleep interact and evolve each other during the early years is vital for supporting the well-being of both infants and their families.

The primary objective of this study is to determine how parent-infant interactions influence changes in infant sleep patterns over the first three years of life, enabling the examination of bidirectional linkages and within-person associations between variations in parent and infant sleep. The second objective is to identify predictors of the relationship between parent and child sleep. Moreover, this study will enable the investigators to establish a birth cohort, which will serve as a valuable resource for addressing future research questions and advancing knowledge in this field.

This study adopts a longitudinal, prospective design. Families who are pregnant with first child in the second or third trimester will be invited to participate. Recruitment will take place from January to December 2025. Parents will be followed across seven time points: during pregnancy (second or third trimester) and at 3, 6, 12, 18, 24, and 36 months postpartum.

Sociodemographic information also will be collected. Parents will be assessed by Patient Health Questionnaire-9, Generalized Anxiety Disorder-7, Pittsburgh Sleep Quality Index, Coparenting Relationship Scale, Maternal Self-Efficacy Scale, Parental Stress Scale, Paternal Involvement Questionnaire. Sleep of children will be evaluated by the Turkish version of the expanded brief infant sleep questionnaire and the infant's social and emotional development will be assessed by Brief Infant Toddler Social Emotional Assessment. Child's temperament will be assessed with one question.

Eligibility criteria: Inclusion Criteria:

* Being pregnant with the first child Gestational age\>12 weeks Parents over the age 18 Fluent in Turkish Parents living in Istanbul

Exclusion Criteria:

* Suicidal ideation in Patient Health Questionnaire-9 (PHQ-9) No internet access

Primary outcomes:
measure: Infant sleep-wake patterns
timeFrame: 3rd, 6th, 12th, 18th, 24th and 36th months
Secondary outcomes:
measure: Prenatal co-parenting relationship
timeFrame: Baseline
measure: Co-parenting relationship
timeFrame: 3rd, 6th, 12th, 18th, 24th and 36th months
measure: Maternal Self Efficacy
timeFrame: 3rd, 6th, 12th, 18th, 24th and 36th months
measure: Maternal and Paternal Depression Symptoms
timeFrame: Baseline, 3rd, 6th, 12th, 18th, 24th and 36th months
measure: Paternal Involvement
timeFrame: 12th. And 36th. months
measure: Maternal and Paternal Sleep Quality
timeFrame: Baseline, 3rd, 6th, 12th, 18th, 24th and 36th months
measure: Parental Stress
timeFrame: 3rd, 6th, 12th, 18th, 24th and 36th months
measure: Child's Temperament
timeFrame: 3rd, 6th, 12th, 18th, 24th and 36th months
measure: Maternal and Paternal Anxiety
timeFrame: Baseline, 3rd, 6th, 12th, 18th, 24th and 36th months
measure: Infant's Social and Emotional Development
timeFrame: 12th., 18th., 24th. and 36th months
Other outcomes:
Locations:
Study officials:
References:
citation: Karabekiroglu K, Rodopman-Arman A, Ay P, Ozkesen M, Akbas S, Tasdemir GN, Boke O, Peksen Y. The reliability and validity of the Turkish version of the brief infant-toddler social emotional assessment (BITSEA). Infant Behav Dev. 2009 Jun;32(3):291-7. doi: 10.1016/j.infbeh.2009.03.003. Epub 2009 May 2.
citation: Williamson AA, Mindell JA, Hiscock H, Quach J. Longitudinal sleep problem trajectories are associated with multiple impairments in child well-being. J Child Psychol Psychiatry. 2020 Oct;61(10):1092-1103. doi: 10.1111/jcpp.13303. Epub 2020 Jul 26.
citation: Teti DM, Gelfand DM. Behavioral competence among mothers of infants in the first year: the mediational role of maternal self-efficacy. Child Dev. 1991 Oct;62(5):918-29. doi: 10.1111/j.1467-8624.1991.tb01580.x.
citation: Feinberg ME, Brown LD, Kan ML. A Multi-Domain Self-Report Measure of Coparenting. Parent Sci Pract. 2012 Jan 1;12(1):1-21. doi: 10.1080/15295192.2012.638870. Epub 2012 Jan 20.
citation: Sadeh A. A brief screening questionnaire for infant sleep problems: validation and findings for an Internet sample. Pediatrics. 2004 Jun;113(6):e570-7. doi: 10.1542/peds.113.6.e570.
citation: Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
citation: Yazici Gulec M, Gulec H, Simsek G, Turhan M, Aydin Sunbul E. Psychometric properties of the Turkish version of the Patient Health Questionnaire-Somatic, Anxiety, and Depressive Symptoms. Compr Psychiatry. 2012 Jul;53(5):623-9. doi: 10.1016/j.comppsych.2011.08.002. Epub 2011 Oct 13.
citation: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
citation: Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
citation: Cook F, Conway LJ, Giallo R, Gartland D, Sciberras E, Brown S. Infant sleep and child mental health: a longitudinal investigation. Arch Dis Child. 2020 Jul;105(7):655-660. doi: 10.1136/archdischild-2019-318014. Epub 2020 Mar 9.
citation: Boran P, Ergin A, Us MC, Dinleyici M, Velipasaoglu S, Yalcin SS, Barutcu A, Gokcay G, Gur E, Camurdan Duyan A, Aydin A, Celep G, Almis H, Savci G, Kondolot M, Nalbantoglu B, Unver Korgali E, Yendur O, Orhon Simsek F, Kara Uzun A, Bag O, Koc F, Bulbul S. Young children's sleep patterns and problems in paediatric primary healthcare settings: a multicentre cross-sectional study from a nationally representative sample. J Sleep Res. 2022 Dec;31(6):e13684. doi: 10.1111/jsr.13684. Epub 2022 Jul 5.
citation: Sadeh A, Tikotzky L, Kahn M. Sleep in infancy and childhood: implications for emotional and behavioral difficulties in adolescence and beyond. Curr Opin Psychiatry. 2014 Nov;27(6):453-9. doi: 10.1097/YCO.0000000000000109.
citation: Mindell JA, Sadeh A, Wiegand B, How TH, Goh DY. Cross-cultural differences in infant and toddler sleep. Sleep Med. 2010 Mar;11(3):274-80. doi: 10.1016/j.sleep.2009.04.012. Epub 2010 Feb 6.
citation: Meltzer LJ, Williamson AA, Mindell JA. Pediatric sleep health: It matters, and so does how we define it. Sleep Med Rev. 2021 Jun;57:101425. doi: 10.1016/j.smrv.2021.101425. Epub 2021 Jan 19.
citation: Covington LB, Patterson F, Hale LE, Teti DM, Cordova A, Mayberry S, Hauenstein EJ. The contributory role of the family context in early childhood sleep health: A systematic review. Sleep Health. 2021 Apr;7(2):254-265. doi: 10.1016/j.sleh.2020.11.010. Epub 2021 Jan 10.