Table 4.
Outcomes of questionnaires used to determine effect of melatonin on sleep problems in children with neurodevelopmental disorders. Figures are mean (SD) scores
| Melatonin | Placebo | Adjusted difference (95% CI) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| No of children | Baseline | Week 12 | Change | No of children | Baseline | Week 12 | Change | |||
| CSDI scale 0-12 | 60 | 7.5 (2.4) | 5.1 (2.9) | −2.4 (2.8) | 65 | 7.0 (2.1) | 5.8 (2.5) | −1.3 (2.2) | −1.00 (−1.8 to −0.2)* | |
| Aberrant behaviour checklist: | ||||||||||
| Irritability, agitation, crying (scale 0-45) | 64 | 16.6 (10.3) | 13.5 (10.1) | −3.1 (6.6) | 68 | 15.5 (10.3) | 13.6 (10.0) | −1.9 (6.7) | −1.0 (−3.1 to 1.2) | |
| Lethargy, social withdrawal (scale 0-48) | 60 | 12.4 (9.6) | 9.3 (8.3) | −3.1(6.2) | 67 | 10.8 (8.8) | 8.0 (7.5) | −2.8(6.0) | 0.3 (−1.5 to 2.1) | |
| Stereotypic behaviour (scale 0-21) | 64 | 6.1 (4.9) | 5.1 (4.5) | −1.0 (3.6) | 69 | 5.0 (4.8) | 4.3 (4.1) | −0.7 (3.4) | 0.1(−0.9 to 1.2) | |
| Hyperactivity, non- compliance (scale 0-48) | 64 | 23.5 (9.9) | 18.6 (10.4) | −4.9 (7.7) | 68 | 21.9 (11.1) | 18.9 (11.2) | −3.0 (8.5) | −1.5 (−4.1 to 1.2) | |
| Inappropriate speech (scale 0-12) | 64 | 4.8 (3.2) | 3.5 (2.7) | −1.3 (2.7) | 67 | 3.7 (3.2) | 3.2 (3.2) | −0.6 (2.2) | −0.4 (−1.1 to 0.4) | |
| PedsQL family impact module: | ||||||||||
| HRQoL (scale 0-100) | 64 | 53.3 (17.5) | 58.7 (20.8) | 5.4 (14.7) | 69 | 56.2 (18.0) | 57.5 (20.6) | 1.3 (15.7) | 3.5 (−1.6 to 8.7) | |
| Family functioning (scale 0-100) | 64 | 50.2 (21.3) | 56.6 (23.6) | 6.4 (16.9) | 69 | 50.1 (22.8) | 52.1 (23.7) | 2.0 (14.6) | 4.4 (−0.8 to 9.7) | |
| ESS (scale 0-24) | 62 | 6.7 (5.4) | 5.4 (4.5) | −1.3 (5.0) | 66 | 6.9 (5.3) | 7.1 (5.0) | 0.3 (3.8) | −1.6 (−2.9 to −0.3)* | |
CSDI=composite sleep disturbance index; PedsQL=paediatric quality of life inventory; HRQoL=health related quality of life; ESS=Epworth sleepiness scale.
*P<0.05
†Higher scores are worse for CSDI, ABC, and ESS, and lower scores are worse for PedsQL.