Table 3.
Comparison of secondary outcomes between intervention and control children
| Outcomes | Intervention group | Control group | Adjusted difference (intervention−control) | Adjusted difference with multiple imputation (intervention−control) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No | Mean (SD) | No | Mean (SD) | Mean (95% CI) | Effect size | P value | Mean (95% CI) | Effect size | P value | |||
| Child sleep habits questionnaire—total score: | ||||||||||||
| Baseline | 121 | 57.8 (8.8) | 121 | 59.0 (7.8) | — | — | — | — | — | — | ||
| 3 months | 79 | 50.1 (8.3) | 83 | 55.1 (8.6) | –6.6 (–8.5 to –4.6) | –1.0 | <0.001 | –5.9 (–7.9 to –3.9) | –0.8 | <0.001 | ||
| 6 months | 102 | 53.2 (7.5) | 95 | 55.9 (8.8) | –3.8 (–5.6 to –2.0) | –0.6 | <0.001 | –3.8 (–5.7 to –1.9) | –0.6 | <0.001 | ||
| Pediatric quality of life inventory 4.0—psychosocial quality of life score: | ||||||||||||
| Baseline | 122 | 49.8 (12.5) | 122 | 48.6 (13.8) | — | — | — | — | — | — | ||
| 3 months | 77 | 61.7 (15.8) | 82 | 51.1 (13.2) | 9.4 (5.6 to 13.2) | 0.8 | <0.001 | 8.9 (5.2 to 12.6) | 0.7 | <0.001 | ||
| 6 months | 104 | 59.0 (15.0) | 94 | 52.1 (13.7) | 6.4 (2.7 to 10.1) | 0.5 | 0.001 | 6.0 (2.2 to 9.8) | 0.4 | 0.002 | ||
| Daily parent rating of evening and morning behaviour—total score: | ||||||||||||
| Baseline | 122 | 22.6 (5.0) | 122 | 22.7 (5.8) | — | — | — | — | — | — | ||
| 3 months | 77 | 16.6 (5.8) | 82 | 21.0 (5.8) | –4.7 (–6.5 to –2.8) | –0.8 | <0.001 | –3.8 (–5.6 to –2.1) | –0.6 | <0.001 | ||
| 6 months | 104 | 18.3 (6.4) | 95 | 20.7 (5.7) | –2.4 (–4.1 to –0.8) | –0.4 | 0.004 | –2.2 (–3.9 to –0.5) | –0.4 | 0.009 | ||
| Depression anxiety stress scales—total score: | ||||||||||||
| Baseline | 116 | 36.8 (25.3) | 115 | 39.6 (27.8) | — | — | — | — | — | — | ||
| 3 months | 74 | 29.4 (21.7) | 80 | 34.7 (26.9) | –5.3 (–13.0 to 2.4) | –0.2 | 0.18 | –5.1 (–11.1 to 0.9) | –0.3 | 0.09 | ||
| 6 months | 101 | 31.1 (23.6) | 90 | 33.9 (28.5) | –4.9 (–12.2 to 2.4) | 0.19 | 0.19 | –1.7 (–7.1 to 3.8) | –0.1 | 0.55 | ||
| Strengths and difficulties questionnaire parent report—total score | ||||||||||||
| Baseline | 122 | 22.6 (5.7) | 122 | 21.9 (5.4) | — | — | — | — | — | — | ||
| 3 months | 78 | 18.6 (5.0) | 82 | 21.4 (5.4) | –3.0 (–4.3 to –1.7) | –0.7 | <0.001 | –2.2 (–3.6 to –0.9) | –0.5 | 0.001 | ||
| 6 months | 103 | 18.7 (5.6) | 95 | 21.2 (5.5) | –2.1 (–3.4 to –0.7) | –0.4 | 0.003 | –1.9 (–3.3 to –0.6) | –0.4 | 0.006 | ||
| Strengths and difficulties questionnaire teacher report—total score: | ||||||||||||
| Baseline | 103 | 15.0 (7.3) | 101 | 17.2 (6.8) | — | — | — | — | — | — | ||
| 3 months | 82 | 13.5 (6.6) | 86 | 17.2 (6.8) | –1.7 (–3.4 to –0.1) | –0.2 | 0.04 | –1.8 (–3.3 to –0.3) | –0.3 | 0.02 | ||
| 6 months | 98 | 12.8 (6.7) | 98 | 16.5 (6.7) | –2.4 (–4.3 to –0.5) | –0.3 | 0.01 | –2.0 (–3.8 to –0.2) | –0.3 | 0.03 | ||
Differences (change in symptom severity from baseline for child sleep habits questionnaire, and difference in severity for strengths and difficulties questionnaire teacher report) adjusted for children’s age, sex, medication use (yes or no), total number of mental health comorbidities, parental age, parental completion of high school (yes or no), socioeconomic status (index of relative socioeconomic disadvantage).
For parent reported outcomes mean intervention versus control differences in change from baseline to outcome at three and six months adjusted for all confounding variables; for teacher reported outcomes, mean intervention versus control differences in outcome at three and six months, adjusted for baseline scores and all confounding variables.