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

Ben-Gurion University of the Negev

Status: Enrolling

Conditions: Insomnia

Treatments: Behavioral: bedtime intervention for early childhood insomnia; Behavioral: bedtime and nighttime intervention for early childhood insomnia

Study type: Interventional

Funder types: Other

Identifiers

NCT05726890

0276-22-SOR

Details and patient eligibility

About

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").

Full 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.

Enrollment: 230 estimated patients

Sex: All

Ages: 9 to 18 months old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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230 participants in 2 patient groups

bedtime checking

Experimental group

Description:

The intervention is based on the principles of graduated extinction, defined as an "effective and recommended therapy in the treatment of bedtime problems and night-wakings" by the AASM. The basic guidelines for this intervention are: (1) When the infant shows tired signs, he/she should be put to bed awake; (2) parents should minimize their involvement after putting the infant to bed; (3) if the child protests/cries, the parent should check the infant's crib every few minutes (e.g., 5 minutes), briefly comfort the infant without taking him/her out of the crib, and help the infant resume a sleeping position/find sleep aids (e.g., pacifier); (4) disengage and leave the crib until the next visit, (5) In order to increase consistency, the same parent should implement the intervention. In the "bedtime checking" arm, parents will be instructed to implement the changes only at bedtime and will be asked to continue soothing their infant at night, as they normally do

Treatment:

Behavioral: bedtime intervention for early childhood insomnia

standard checking

Active Comparator group

Description:

Same as for "bedtime checking" at bedtime, but in the standard checking arm, parents apply the intervention guidelines also when the infant wakes up during the night.

Treatment:

Behavioral: bedtime and nighttime intervention for early childhood insomnia