Examining the Effectiveness of Two Behavioral Interventions for Sleep Problems in Infants

Официальное название

Early Childhood Insomnia: Underlying Mechanisms of Intervention Effects of the "Bedtime Checking" and the "Standard Checking" Methods

Обзор

Behavioral insomnia of childhood affects 15-30% of infants. Behavioral interventions, based on limiting parent-child bedtime and nighttime interactions, are effective in significantly improving infant sleep problems. However, the implementation of these interventions frequently encompasses significant infant crying and parental distress that deter many parents. Research on gradual sleep interventions that involve a lower "dose" of parent-infant separation, and thus may be more acceptable by parents, has so far been sparse. The proposed study aims to advance research in this area through systematically studying the processes through which parent and infant factors impact treatment outcomes of a behavioral intervention method that involves parent-infant separation only at bedtime ("bedtime checking"), in comparison to an intervention that also directly targets night-wakings ("standard checking"/"graduated extinction").

Подробное описание

Early-childhood insomnia is very prevalent and is associated with negative child and family outcomes. Behavioral interventions, based on limiting parent-child nocturnal interactions, are effective in significantly improving infant sleep. However, these interventions frequently involve significant parent and infant distress that deter many parents. Research on gradual sleep interventions that involve a lower "dose" of parent-infant separation, and thus may be more accepted by many parents, has so far been sparse. Moreover, little scientific attention has been paid to factors that may underlie parental compliance with behavioral sleep interventions and treatment outcomes. Accordingly, the main aim of the proposed study is to study the processes through which parent and infant factors impact treatment adherence and outcomes of a behavioral intervention method that involves parent-infant separation only at bedtime ("bedtime checking"), compared to a method that also targets night-wakings ("standard checking").

The investigators will recruit 270 infants with early-childhood insomnia and their parents. Following a baseline assessment, infants will be randomly assigned to the "bedtime checking" intervention or to "standard checking". Within this total enrollment, a wait-list control group (WL-CTRL) of 40 families will be added starting in May 2026. These families will remain without intervention for 5 weeks, at which point they will only complete an infant sleep questionnaire. After this 5-week assessment, families will be briefed on both study interventions and may choose which one they would like to implement.

Sleep assessment will include actigraphy, videosomnography, and sleep logs. Parents will complete baseline procedures and questionnaires to assess intervention moderators (e.g., parental emotional distress, infant temperament). Daily diaries will be used to assess predictors/mediators of treatment adherence and outcomes (e.g., parental stress, couple support). Assessments will be conducted during the intervention, and at 4 weeks, 6-months and 12-months post-treatment.

The main hypotheses are: (1a) Compared with the WL-CTRL, "Bedtime checking" and Standard checking" will results in improved infant sleep outcomes (e.g., reduced number and length of night-wakings). (1b) For parents who adhere to their intervention, the "standard checking" method will obtain sleep outcomes more quickly; (1c) The "bedtime checking" method will lead to higher parental adherence and lower attrition, compared to "standard checking"; (2) Significant interactions between baseline parent/infant risk characteristics and type of intervention would be found in the prediction of sleep outcomes; (3) In both groups, higher adherence to the intervention and better sleep outcomes will be predicted by: (i) lower parental stress, guilt, and distress attributions, and (ii) higher perceived couple support; By systematically studying, for the first time, the "bedtime checking" method (that probably will be more acceptable to many parents), compared to "standard checking", findings promise to shed light on theory-based mediators and moderators through which behavioral sleep interventions might exercise their benefits.

Вмешательства

• Поведенческое bedtime intervention for early childhood insomnia
  The intervention focuses on providing parents with skills on how to modify and limit their sleep-related interactions with their infant at bedtime. These changes are expected to foster the infant's ability to fall asleep independently at bedtime. It is also expected that after 1-2 weeks, these changes would lead to self-soothing also during the night. \*Also provided to wait-list control participants upon request after their 5-week control assessment
• Поведенческое bedtime and nighttime intervention for early childhood insomnia
  The intervention focuses on providing parents with skills on how to modify and limit their sleep-related interactions with their infant at bedtime and during the night. These changes are expected to foster the infant's ability to fall asleep independently at bedtime and to resume sleep independently during the night. \*Also provided to wait-list control participants upon request after their 5-week control assessment.

Первичные конечные точки

• Change in infant actigraphic number of night-wakings from baseline to 1-week and 2-week start of intervention [Срок оценки: baseline and 1- and 2-week start of intervention]
• Change in parents' actigraphic number of night-wakings from baseline to 1-week and 2-week start of intervention [Срок оценки: baseline and 1- and 2-week start of intervention]
• Change in infant actigraphic minutes awake during the night from baseline to 1-week and 2-week start of intervention [Срок оценки: baseline and 1- and 2-week start of intervention]
• Change in parents' actigraphic minutes awake during the night from baseline to 1-week and 2-week start of intervention [Срок оценки: baseline and 1- and 2-week start of intervention]
• Change in infant sleep logs' number of night-wakings from baseline to 1-week and 2-week start of intervention. [Срок оценки: baseline and 1- and 2-week start of intervention]
• Change in parents' sleep logs' number of night-wakings from baseline to 1-week and 2-week start of intervention. [Срок оценки: baseline and 1- and 2-week start of intervention]
• Change in infant sleep logs' minutes awake during the night from baseline to 1-week and 2-week start of intervention. [Срок оценки: baseline and 1- and 2-week start of intervention]
• Change in parents' sleep logs' minutes awake during the night from baseline to 1-week and 2-week start of intervention. [Срок оценки: baseline and 1- and 2-week start of intervention]
• Change in infant sleep logs' subjective sleep quality from baseline to 1-week and 2-week start of intervention. [Срок оценки: baseline and 1- and 2-week start of intervention]
• Change in parents' sleep logs' subjective sleep quality from baseline to 1-week and 2-week start of intervention. [Срок оценки: baseline and 1- and 2-week start of intervention]

Вторичные конечные точки (12)

• Change in infant sleep logs' sleep latency from baseline to 2-week start of intervention [Срок оценки: baseline and 2-week start of intervention.]
• Change in infant actigraphic sleep duration from baseline to 2-week start of intervention [Срок оценки: baseline and 2-week start of intervention.]
• Change in infant sleep-logs' sleep duration from baseline to 2-week start of intervention [Срок оценки: baseline and 2-week start of intervention.]
• Change in parents' actigraphic sleep duration from baseline to 2-week start of intervention [Срок оценки: baseline and 2-week start of intervention.]
• Change in parents' sleep-logs' sleep duration from baseline to 2-week start of intervention [Срок оценки: baseline and 2-week start of intervention.]
• Change in infant actigraphic longest sleep period from baseline to 2-week start of intervention. [Срок оценки: baseline and 2-week start of intervention.]
• Change in parents' actigraphic longest sleep period from baseline to 2-week start of intervention. [Срок оценки: baseline and 2-week start of intervention.]
• Change in infant observed sleep latency from baseline to 2-week start of intervention. [Срок оценки: baseline and 2-week start of intervention.]
• Change in infant observed number of night-wakings from baseline to 2-week start of intervention [Срок оценки: baseline and 2-week start of intervention.]
• Change in infant observed minutes awake during the night from baseline to 2-week start of intervention [Срок оценки: baseline and 2-week start of intervention.]
• Change in infant observed sleep duration from baseline to 2-week start of intervention. [Срок оценки: baseline and 2-week start of intervention.]
• Change in infant observed nocturnal self-soothing behavior (i.e., signaled night wakings out of total awakenings) from start of intervention to end of intervention. [Срок оценки: First 3 days of intervention and last 3 days of intervention]

Критерии участия

Критерии включения

• Early-childhood insomnia according to DSM-5 criteria
• The parents wish to sleep independently from the child and would like the infant to need as little help as possible to fall asleep or stay asleep
• Two-parent, Hebrew-speaking families.
• Infants born at term (gestational age > 36 weeks)

Критерии исключения

• Infants and parents with significant physiological sleep problems (e.g., sleep apnea)
• Infants and parents with any chronic health problems (based on self-report).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Израиль · 1 центр

• Ben-Gurion University of the Negev — Beersheba

Публикации

• Mindell JA, Kuhn B, Lewin DS, Meltzer LJ, Sadeh A; American Academy of Sleep Medicine. Behavioral treatment of bedtime problems and night wakings in infants and young children. Sleep. 2006 Oct;29(10):1263-76. PMID 17068979
• Tikotzky L, Sadeh A. The role of cognitive-behavioral therapy in behavioral childhood insomnia. Sleep Med. 2010 Aug;11(7):686-91. doi: 10.1016/j.sleep.2009.11.017. PMID 20620108
• Meltzer LJ, Mindell JA. Systematic review and meta-analysis of behavioral interventions for pediatric insomnia. J Pediatr Psychol. 2014 Sep;39(8):932-48. doi: 10.1093/jpepsy/jsu041. Epub 2014 Jun 19. PMID 24947271
• Sadeh A. Assessment of intervention for infant night waking: parental reports and activity-based home monitoring. J Consult Clin Psychol. 1994 Feb;62(1):63-8. doi: 10.1037//0022-006x.62.1.63. PMID 8034831
• Eckerberg B. Treatment of sleep problems in families with young children: effects of treatment on family well-being. Acta Paediatr. 2004 Jan;93(1):126-34. doi: 10.1080/08035250310007754. PMID 14989452
• Kahn M, Juda-Hanael M, Livne-Karp E, Tikotzky L, Anders TF, Sadeh A. Behavioral interventions for pediatric insomnia: one treatment may not fit all. Sleep. 2020 Apr 15;43(4):zsz268. doi: 10.1093/sleep/zsz268. PMID 31676910
• Gradisar M, Jackson K, Spurrier NJ, Gibson J, Whitham J, Williams AS, Dolby R, Kennaway DJ. Behavioral Interventions for Infant Sleep Problems: A Randomized Controlled Trial. Pediatrics. 2016 Jun;137(6):e20151486. doi: 10.1542/peds.2015-1486. PMID 27221288

Идентификаторы

NCT: NCT05726890 · 0276-22-SOR

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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