Cognitive-behavioral Therapy for Insomnia in School-aged Children

Insomnia stands out as the most prevalent sleep disorder in youth, inflicting a range of adverse consequences on both the child and the family. While cognitive-behavioral therapy for insomnia (CBT-I) is considered the first-line treatment, empirical investigations into its efficacy in school-aged children have been scarce. Moreover, the unique contributions and underlying mechanisms of individual treatment components of the CBT-I 'package' remain poorly understood. Sleep Restriction Therapy (SRT) is acknowledged as a core module of CBT-I in adults, presumably driving clinical change via increases in homeostatic sleep pressure that facilitate sleep onset and maintenance. Yet, the incremental benefits of SRT within the context of CBT-I have not been systematically examined. Similarly, the role of two key mechanisms in the CBT-I 'package'-pre-sleep hyperarousal and parental over-accommodation-as mediators of treatment outcome has not been investigated. As for treatment moderators, the frequently encountered lack of motivation among children to engage in therapy poses a notable barrier to effective insomnia treatment, a barrier that SRT may potentially alleviate by offering the appeal of a later bedtime. Given the unique characteristics of insomnia in school-aged children and the prominent role played by parents in etiology and treatment, understanding these processes is pivotal. The proposed dismantling trial is designed to address these issues by rigorously testing the efficacy of CBT-I, including and excluding the SRT module, meticulously examining underlying mechanisms, and determining which variation of the intervention may be more suitable for specific children.

A total of 120 children aged 7-11 with chronic insomnia disorder will be randomized to one of 3 study arms: (1) CBT-I; (2) CBT-I without SRT; or (3) a waitlist control group. Assessments will occur at baseline, mid- treatment, post-treatment, and 3-month follow-up. Insomnia and sleep-wake patterns will be assessed objectively via actigraphy, complemented by parent and child questionnaires, sleep diaries, and a clinical diagnostic interview. Additional factors will be measured, including the child's presleep hyperarousal, separation anxiety, behavioral and emotional problems, as well as parental accommodation, distress and anxiety, and cry tolerance. Some of these factors will be tested as possible mediators (pre-sleep hyperarousal, parental accommodation, child motivation to engage in treatment, and family adherence to treatment) and moderators (parent and child levels of emotional or behavioral problems at baseline) of treatment outcome. Parents' satisfaction with treatment will also be assessed at post-treatment. Participants allocated to the waitlist control group will all receive CBT-I after the 5-week waiting period.

• Child sleep duration - actigraphic [Time frame: Baseline, mid-treatment (3 weeks following baseline), post-treatment (5 weeks following baseline), and follow-up (three months following baseline)]
• Child sleep duration - parent reports [Time frame: Baseline, mid-treatment (3 weeks following baseline), post-treatment (5 weeks following baseline), and follow-up (three months following baseline)]
• Child number of awakenings - actigraphic [Time frame: Baseline, mid-treatment (3 weeks following baseline), post-treatment (5 weeks following baseline), and follow-up (three months following baseline)]
• Child number of awakenings - parent reports [Time frame: Baseline, mid-treatment (3 weeks following baseline), post-treatment (5 weeks following baseline), and follow-up (three months following baseline)]
• Number of nights of co-sleeping [Time frame: Baseline, mid-treatment (3 weeks following baseline), post-treatment (5 weeks following baseline), and follow-up (three months following baseline)]
• Child sleep related problems [Time frame: Baseline, mid-treatment (3 weeks following baseline), post-treatment (5 weeks following baseline), and follow-up (three months following baseline)]