Clinical trial NCT05726890: Examining the Effectiveness of Two Behavioral Interventions for Sleep Problems in Infants
Official title: Early Childhood Insomnia: Underlying Mechanisms of Intervention Effects of the "Bedtime Checking" and the "Standard Checking" Methods
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Keywords: sleep
early childhood insomnia
infant
parent
behavioral sleep interventions
Lead sponsor: Ben-Gurion University of the Negev
Sponsor class: OTHER
First posted: 2023-02-14
Enrollment: 230
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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").

Detailed description: 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 230 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". 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) For parents who adhere to their intervention, the "standard checking" method will obtain sleep outcomes more quickly; (1b) 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in infant actigraphic number of night-wakings from baseline to 1-week and 2-week start of intervention
timeFrame: baseline and 1- and 2-week start of intervention
measure: Change in parents' actigraphic number of night-wakings from baseline to 1-week and 2-week start of intervention
timeFrame: baseline and 1- and 2-week start of intervention
measure: Change in infant actigraphic minutes awake during the night from baseline to 1-week and 2-week start of intervention
timeFrame: baseline and 1- and 2-week start of intervention
measure: Change in parents' actigraphic minutes awake during the night from baseline to 1-week and 2-week start of intervention
timeFrame: baseline and 1- and 2-week start of intervention
measure: Change in infant sleep logs' number of night-wakings from baseline to 1-week and 2-week start of intervention.
timeFrame: baseline and 1- and 2-week start of intervention
measure: Change in parents' sleep logs' number of night-wakings from baseline to 1-week and 2-week start of intervention.
timeFrame: baseline and 1- and 2-week start of intervention
measure: Change in infant sleep logs' minutes awake during the night from baseline to 1-week and 2-week start of intervention.
timeFrame: baseline and 1- and 2-week start of intervention
measure: Change in parents' sleep logs' minutes awake during the night from baseline to 1-week and 2-week start of intervention.
timeFrame: baseline and 1- and 2-week start of intervention
measure: Change in infant sleep logs' subjective sleep quality from baseline to 1-week and 2-week start of intervention.
timeFrame: baseline and 1- and 2-week start of intervention
measure: Change in parents' sleep logs' subjective sleep quality from baseline to 1-week and 2-week start of intervention.
timeFrame: baseline and 1- and 2-week start of intervention
measure: Attrition from intervention
timeFrame: baseline and 2-week start of intervention.
Secondary outcomes:
measure: Change in infant sleep logs' sleep latency from baseline to 2-week start of intervention
timeFrame: baseline and 2-week start of intervention.
measure: Change in infant actigraphic sleep duration from baseline to 2-week start of intervention
timeFrame: baseline and 2-week start of intervention.
measure: Change in infant sleep-logs' sleep duration from baseline to 2-week start of intervention
timeFrame: baseline and 2-week start of intervention.
measure: Change in parents' actigraphic sleep duration from baseline to 2-week start of intervention
timeFrame: baseline and 2-week start of intervention.
measure: Change in parents' sleep-logs' sleep duration from baseline to 2-week start of intervention
timeFrame: baseline and 2-week start of intervention.
measure: Change in infant actigraphic longest sleep period from baseline to 2-week start of intervention.
timeFrame: baseline and 2-week start of intervention.
measure: Change in parents' actigraphic longest sleep period from baseline to 2-week start of intervention.
timeFrame: baseline and 2-week start of intervention.
measure: Change in infant observed sleep latency from baseline to 2-week start of intervention.
timeFrame: baseline and 2-week start of intervention.
measure: Change in infant observed number of night-wakings from baseline to 2-week start of intervention
timeFrame: baseline and 2-week start of intervention.
measure: Change in infant observed minutes awake during the night from baseline to 2-week start of intervention
timeFrame: baseline and 2-week start of intervention.
measure: Change in infant observed sleep duration from baseline to 2-week start of intervention.
timeFrame: baseline and 2-week start of intervention.
measure: 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.
timeFrame: First 3 days of intervention and last 3 days of intervention
measure: Change in infant observed nocturnal self-soothing behavior from start of intervention to end of intervention.
timeFrame: First 3 days of intervention and last 3 days of intervention
measure: Adherence with intervention guidelines - interval from infant crying to parental approach
timeFrame: Measured daily during the two week intervention.
measure: Adherence with intervention guidelines - total time of parental presence in infant room
timeFrame: Measured daily during the two week intervention.
measure: Adherence with intervention guidelines - type of parental help.
timeFrame: Measured daily during the two week intervention.
measure: Adherence with intervention guidelines based on daily logs.
timeFrame: Measured daily during the two week intervention.
measure: Change in infant actigraphic number of night-wakings from baseline to 4 weeks post intervention and to 6 and 12 months post intervention.
timeFrame: baseline and 4 weeks, 6 months, 12 months post intervention.
measure: Change in parent actigraphic number of night-wakings from baseline to 4 weeks post intervention and to 6 and 12 months post intervention.
timeFrame: baseline and 4 weeks, 6 months, 12 months post intervention.
measure: Change in infant actigraphic minutes awake during the night from baseline to 4 weeks post intervention and to 6 and 12 months post intervention.
timeFrame: baseline and 4 weeks, 6 months, 12 months post intervention.
measure: Change in parent actigraphic minutes awake during the night from baseline to 4 weeks post intervention and to 6 and 12 months post intervention.
timeFrame: baseline and 4 weeks, 6 months, 12 months post intervention.
measure: Change in infant daily logs' number of night-wakings from baseline to 4 weeks post intervention and to 6 and 12 months post intervention.
timeFrame: baseline and 4 weeks, 6 months, 12 months post intervention.
measure: Change in parent daily logs' number of night-wakings from baseline to 4 weeks post intervention and to 6 and 12 months post intervention.
timeFrame: baseline and 4 weeks, 6 months, 12 months post intervention.
measure: Change in infant daily logs' minutes awake during the night from baseline to 4 weeks post intervention and to 6 and 12 months post intervention.
timeFrame: baseline and 4 weeks, 6 months, 12 months post intervention.
measure: Change in parent daily logs' minutes awake during the night from baseline to 4 weeks post intervention and to 6 and 12 months post intervention.
timeFrame: baseline and 4 weeks, 6 months, 12 months post intervention.
measure: Change in parents' subjective rating of the infant's sleep problem from baseline to 4 weeks post intervention and to 6 and 12 months post intervention.
timeFrame: baseline and 4 weeks, 6 months, 12 months post intervention.
Other outcomes:
Locations:
city: Be'er Sheva
country: Israel
facility: Ben-Gurion University of the Negev
Study officials:
affiliation: Ben-Gurion University of the Negev
name: Liat Tikotzky, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.