. Author manuscript; available in PMC: 2021 Apr 29.

Published in final edited form as: J Am Acad Child Adolesc Psychiatry. 2020 Jan 23;60(2):252–261.e3. doi: 10.1016/j.jaac.2019.12.007

TABLE 1.

Changes From Baseline in Child Sleep and Caregiver Variables at Week 106 in Pediatric Prolonged-Release Melatonin (PedPRM) and Placebo Groups

Variable	PedPRM (n = 38)^a		Placebo (n = 35)^a
Variable	Mean change from baseline^b	(95% CI)	Mean change from baseline^b	(95% CI)
CSDI (scale of 0–12)	−3.18	(−4.49, −1.86)	−3.59	(−4.86, −2.31)
p^c		< .001		< .001
CSDI caregiver satisfaction (scale of 1–5)	1.79	(1.35,2.24)	1.82	(1.40,2.25)
p^c		< .001		< .001
WHO-5^c (scale of 0–25)	3.44	(1.51,5.36)	1.52	(−0.55, 3.58)
p^c		.001		.145
PSQI (scale of 0–21)	−1.26	(−2.46, −0.07)	−1.88	(−3.28, −0.48)
p^c		.039		.010

Note: CSDI = Composite Sleep Disturbance Index; PSQI = Pittsburgh Sleep Quality Index; WHO-5 = 5-item World Health Organization Well-Being Index.

Participants in the PedPRM randomized group had 104 weeks of continuous treatment, and participants in the placebo group had 91 weeks of continuous PedPRM treatment.

Baseline = 2 weeks single-blind placebo run-in before randomization.

Paired t test for the change from baseline levels, significance at p < .05.