Background
Methods
Ethics statement
Participants and procedures
Intervention
Sleep intervention
Information about infants’ patterns (cognitions)
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▪ Infants have developmental shifts | |
▪ Infant feeding requirements at night | |
▪ Sleep-wake-feed-play and usual sleep patterns and typical sleep progression | |
▪ Infant behaviors associated with sleep types and tiredness cues | |
Negative Sleep Associations (cognitions)
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▪ Movement to sleep | |
▪ Feeding to sleep | |
▪ Putting an infant to bed asleep | |
▪ Reactive co-sleeping | |
Unrealistic expectations about sleep (cognitions)
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▪ Less napping and late bedtimes will promote night sleep | |
▪ Nap and bedtimes do not matter | |
▪ Parents’ approaches can differ | |
Effects of sleep loss on infants and parents (cognitions)
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▪ Associations between behavioral sleep problems and infant growth and development | |
▪ Associations between sleep disturbance, parental mood, confidence, and problem-solving | |
Strategies to Reduce Night Waking (behaviors)
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▪ Daytime, bedtime, and naptime routines | |
▪ Minimal stimulation before bed | |
▪ Feeding 20 min prior to settling | |
▪ Controlled comforting with periodic checking | |
▪ Avoid reactive co-sleeping |
Safety control
Training and intervention fidelity
Content
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▪ Circadian rhythms & sleep cycle characteristics | |
▪ Normal sleep amount & patterns for 6-to-12 month-olds | |
▪ Developmental shifts in infant sleep and unrealistic parental expectations | |
▪ Effects of sleep fragmentation & short cycles | |
▪ Routines daytime & pre-sleep | |
▪ Negative sleep associations | |
▪ Effects of sleep problems on infants | |
▪ Effects of sleep problems on parents | |
▪ Trials and reviews of behavioral sleep interventions | |
▪ Strategies to reduce night waking | |
▪ Screening infants for conditions requiring medical referral | |
Skills
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▪ Screening infants for conditions requiring medical referral |
Outcome measures
Statistical analyses
Results
Category | Sleep intervention | Safety control |
---|---|---|
Infants | n = 117 | n = 118 |
Age, mean (SD), mo | 6.7 (0.92) | 6.8 (0.96) |
Male, No. (%) | 74 (64) | 57 (48)** |
Breastfed, No. (%) | 99 (85) | 113 (96)** |
Parents | n = 229 | n = 233 |
Age, mean (SD), y | 35.5 (5.6) | 35.4 (5.1) |
Married or in stable relationship, No. (%) | 110 (97) | 110 (97) |
Number of children, mean (SD) | 1.3 (0.7) | 1.3 (0.7) |
Education, mean (SD), y | 17 (2.8) | 17 (2.8) |
Family Income, Canadian dollars, No. (%) | ||
$10,000 - 29,999 | 12 (6) | 8 (4) |
$30,000 - 59,999 | 22 (11) | 42 (20) |
$60,000 - $89,999 | 36 (17) | 42 (20) |
$90,000 -109,000 | 56 (27) | 32 (15) |
≥ $110,000 | 81 (39) | 91 (42)a |
Cultural Identity, No. (%)b | ||
Canadian | 111 (50) | 123 (54) |
Chinese | 23 (10) | 19 (8) |
European | 30 (14) | 25 (11) |
South Asian | 21 (9) | 20 (9) |
Other | 38 (17) | 42 (18) |
Primary outcome
Sleep intervention | Safety control | Adjusted difference at outcome | 95 % confidence interval | P-value | |||
---|---|---|---|---|---|---|---|
Baseline | 6 Week | Baseline | 6 Week | ||||
Actigraphy | n = 113 | n = 96 | n = 109 | n = 96 | |||
Night wake episodes | 8.2 (3.8) | 7.9 (5.4) | 8.8 (3.4) | 7.7 (4.3) | −0.2 | −1.32 to 0.91 | 0.72 |
Long wake episodes | 4 (1.5) | 3.2 (1.6) | 4.2 (1.4) | 3.2 (1.2) | 0.02 | −0.35 to 0.4 | 0.91 |
Longest sleep period | 164 (46.2) | 204.4 (87.5) | 168 (53.2) | 188.1 (50.2) | 20.02 | 0.48 to 39.56 | 0.05 |
Sleep diary | n = 114 | n = 106 | n = 116 | n = 106 | |||
Night wake episodes | 3.1 (1.2) | 1.7 (1) | 3.1 (1.2) | 2.2 (1.1) | −0.45 | −0.7 to −0.19 | <.001 |
% infants with sleep problem (average = 2 wakes per night) | 93 (81.6 %) | 33 (31.1 %) | 96 (82.8 %) | 64 (60.4 %) | −29.9 % | −43.63 to −16.22 | <.001 |
Parent report | n = 117 | n = 108 | n = 118 | n = 107 | |||
% of infants with severe night waking | 32 (14 %) | 4 (4 %) | 44 (18 %) | 15 (14 %) | −10 % | −16.8 to −2.2 | 0.01 |
Secondary outcomes
Baseline mean (SD) (n) | 6 week follow-up mean (SD) (n) | Baseline adjusted difference | 95 % confidence interval | P-value | |
---|---|---|---|---|---|
Fatigue MAFa | |||||
Sleep intervention | 26.8 (9.2) (n = 206) | 18.7 (8.1) (n = 206) | −3.7 | −5.74 to −1.68 | 0.001 |
Safety control | 27.1 (8.6) (n = 204) | 22.3 (9.2) (n = 204) | |||
Depression CES-Db | |||||
Sleep intervention | 13.8 (9) (n = 206) | 9.4 (7.7) (n = 206) | −2 | −3.7 to −0.4 | 0.02 |
Safety control | 15.4 (10.2) (n = 205) | 12 (9) (n = 205) | |||
Sleep quality PSQIc | |||||
Sleep intervention | 8.1 (3.6) (n = 206) | 5.7 (3) (n = 206) | −0.88 | −1.5 to −0.2 | 0.009 |
Safety control | 8.3 (3.4) (n = 201) | 6.5 (3.3) (n = 202) | |||
Cognitions MCISQd | |||||
Sleep intervention | n = 223 | n = 205 | |||
Safety control | n = 230 | n = 205 | |||
Sleep doubtse | |||||
Sleep intervention | 7.2 (4.1) | 4.3 (3.6) | −1.3 | −2.0 to −0.6 | <.001 |
Safety control | 6.9 (4.2) | 5.5 (4) | |||
Sleep angerf | |||||
Sleep intervention | 6.8 (3.4) | 5.2 (3.1) | −1.1 | −1.8 to −0.4 | 0.003 |
Safety control | 7.3 (4) | 6.5 (3.8) | |||
Sleep and feedingg | |||||
Sleep intervention | 7.3 (3.6) | 3.9 (3.4) | −1.4 | −2.1 to −0.7 | <.001 |
Safety control | 6.9 (3.6) | 5.2 (3.3) | |||
Setting sleep limitsh | |||||
Sleep intervention | 14.9 (4.9) | 10.1 (4.8) | −2.48 | −3.5 to −1.5 | <.001 |
Safety control | 14.9 (4.9) | 12.4 (5.2) | |||
Sleep safetyi | |||||
Sleep intervention | 2.9 (2.5) | 1.9 (2) | −0.3 | 0.7 to 0.1 | 0.12 |
Safety control | 2.7 (2.4) | 2.2 (2.3) |
Variable & caregivers | Sleep intervention | Safety control | Baseline adjusted difference | 95 % confidence interval | P value | ||
---|---|---|---|---|---|---|---|
Mean (SD) | n | Mean (SD) | n | ||||
Fatigue MAFa | |||||||
Primary caregiver | 19.3 (8.1) | 108 | 23.5 (9.2) | 105 | −4.2 | −6.45 to −1.96 | <.001 |
Secondary caregiver | 18.1 (8.1) | 98 | 21.1 (9) | 99 | −2.7 | −4.90 to −0.50 | .02 |
Depression CES-Db | |||||||
Primary caregiver | 9.1 (7.9) | 108 | 12.5 (8.4) | 106 | −2.87 | −4.81 to −0.93 | .004 |
Secondary caregiver | 9.7 (7.5) | 98 | 11.5 (9.7) | 100 | −0.77 | −2.89. to 1.36 | .48 |
Sleep quality PSQIc | |||||||
Primary caregiver | 6.2 (3.1) | 108 | 7.1 (3.4) | 107 | −0.88 | −1.70 to −0.06 | .04 |
Secondary caregiver | 5.1 (2.8) | 98 | 5.9 (3.1) | 95 | −0.72 | −1.45 to 0.01 | .05 |
Cognitions MCISQd | |||||||
Sleep doubtse | |||||||
Primary caregiver | 4.6 (3.5) | 108 | 5.9 (4) | 107 | −1.56 | −2.43 to −0.68 | <.001 |
Secondary caregiver | 3.9 (3.7) | 97 | 5.1 (4.1) | 98 | −1.26 | −2.14 to −0.39 | .005 |
Sleep angerf | |||||||
Primary caregiver | 5 (3.3) | 108 | 6.6 (4.2) | 107 | −1.37 | 2.25 to - 0.50 | .002 |
Secondary caregiver | 5.3 (2.9) | 97 | 6.3 (3.3) | 98 | −0.75 | 1.54 to 0.31 | .06 |
Sleep and feedingg | |||||||
Primary caregiver | 4.5 (3.6) | 108 | 6 (3.3) | 107 | −1.59 | 2.41 to - 0.77 | <.001 |
Secondary caregiver | 3.2 (3.2) | 97 | 4.4 (3.2) | 98 | −1.4 | 2.19 to - 0.61 | <.001 |
Setting sleep limitsh | |||||||
Primary caregiver | 10.8 (4.8) | 108 | 13.5 (5.2) | 107 | −2.63 | −3.80 to −1.47 | <.001 |
Secondary caregiver | 9.2 (4.8) | 97 | 11.1 (4.9) | 98 | −2 | −3.12 to −0.88 | <.001 |
Sleep safetyi | |||||||
Primary caregiver | 2.2 (2) | 108 | 2.5 (2.2) | 107 | −0.42 | 0.91 to 0.07 | .09 |
Secondary caregiver | 1.7 (2) | 97 | 2 (2.3) | 98 | −0.3 | 0.80 to 0.20 | .25 |