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

Insomnia Clinical Trial

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

Status Recruiting

Clinical Trial 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").

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

• NCT number: NCT05726890
• Study type: Interventional
• Source: Ben-Gurion University of the Negev
• Contact: Liat Tikotzky, PhD
• Phone: +972545497243
• Email: liatti@bgu.ac.il
• Status: Recruiting
• Phase: N/A
• Start date: March 9, 2023
• Completion date: September 2027