Asian
3%
Source
Peer reviewed?
Yes
Paul, I. M., Savage, J. S., Anzman-Frasca, S., Marini, M. E., Mindell, J. A., & Birch, L. L. (2016). INSIGHT responsive parenting intervention and infant sleep. Pediatrics, 138(1), 1-10. doi:10.1542/peds.2016-0762
Study Registration
Funding Sources
This research was supported by Award Numbers R01DK088244 and UL1TR000127 from the National Institutes of Health and 2011-67001-30117 from the U.S. Department of Agriculture. The research was also supported by the Children’s Miracle Network at Penn State Health Children’s Hospital and the Penn State Clinical and Translational Science Institute.
Study Design
| Design | Attrition | Baseline equivalence | Confounding factors | Valid, reliable measures? |
|---|---|---|---|---|
| Randomized controlled trial | Low | Not assessed for randomized controlled trials with low attrition |
No |
Yes, details reported below for findings on valid, reliable outcomes that otherwise rate at least moderate |
Notes
Information on sample sizes was obtained from Paul et al. (2014) and correspondence with the author. Information to characterize the statistical significance of some findings was based on correspondence with the author.
Study Participants
Study participants were mother and infant dyads recruited after delivery in one Pennsylvania hospital. To be eligible, dyads had to include full-term, singleton births, with infants of normal birth weight. Mothers were English-speaking, primiparous, and at least 20 years old. A total of 291 dyads were randomly assigned to either the Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) intervention (145 dyads) or a comparison intervention (146 dyads). Mother–infant dyads were randomly assigned to the INSIGHT intervention or the comparison intervention two weeks after birth, and outcomes were measured until the children’s first birthday. In the study, 89 percent of mothers were White, 6 percent were Black, 3 percent were Asian, and 1 percent reported another race. Most mothers (56 percent) had annual household incomes between $25,000 and $99,000; 11 percent had annual household incomes below $25,000.
Setting
The study took place in Hershey, Pennsylvania.
Home Visiting Services
INSIGHT consisted of home visits conducted when infants were 3 to 4, 16, 28, and 40 weeks old, followed by annual clinic-based visits at 1, 2, and 3 years old. The curriculum taught parents to respond promptly and in developmentally appropriate ways to infant cues across four behavioral states (drowsy, sleepy, fussy, and alert/calm). Research nurses provided parents with developmentally appropriate sleep guidance during each visit. The guidance addressed bedtime routines, sleep location, and night waking. During and between visits, caregivers were provided with information and resources on responsive feeding, lactation support, soothing practices, and home safety (including crib safety and choking hazards). When infants were 2 weeks old, participants received a mailed packet with information on infant feeding.
Comparison Conditions
Families assigned to the comparison condition were not eligible to receive intervention services through the INSIGHT program. However, these families received a similar number of home visits as the INSIGHT group (when infants were 3 to 4, 16, 28, and 40 weeks old) and annual clinic-based visits at 1, 2, and 3 years old. The home visits focused solely on home safety topics, including crib safety. When infants were 2 weeks old, participants received a mailed packet with information on infant feeding.
Were any subgroups examined?
No
Subgroups examined
There were no subgroups reported in this manuscript.
Study Participants
Study participants were mother and infant dyads recruited after delivery in one Pennsylvania hospital. To be eligible, dyads had to include full-term, singleton births, with infants of normal birth weight. Mothers were English-speaking, primiparous, and at least 20 years old. A total of 291 dyads were randomly assigned to either the Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) intervention (145 dyads) or a comparison intervention (146 dyads). Mother–infant dyads were randomly assigned to the INSIGHT intervention or the comparison intervention two weeks after birth, and outcomes were measured until the children’s first birthday. In the study, 89 percent of mothers were White, 6 percent were Black, 3 percent were Asian, and 1 percent reported another race. Most mothers (56 percent) had annual household incomes between $25,000 and $99,000; 11 percent had annual household incomes below $25,000.
Setting
The study took place in Hershey, Pennsylvania.
Home Visiting Services
INSIGHT consisted of home visits conducted when infants were 3 to 4, 16, 28, and 40 weeks old, followed by annual clinic-based visits at 1, 2, and 3 years old. The curriculum taught parents to respond promptly and in developmentally appropriate ways to infant cues across four behavioral states (drowsy, sleepy, fussy, and alert/calm). Research nurses provided parents with developmentally appropriate sleep guidance during each visit. The guidance addressed bedtime routines, sleep location, and night waking. During and between visits, caregivers were provided with information and resources on responsive feeding, lactation support, soothing practices, and home safety (including crib safety and choking hazards). When infants were 2 weeks old, participants received a mailed packet with information on infant feeding.
Comparison Conditions
Families assigned to the comparison condition were not eligible to receive intervention services through the INSIGHT program. However, these families received a similar number of home visits as the INSIGHT group (when infants were 3 to 4, 16, 28, and 40 weeks old) and annual clinic-based visits at 1, 2, and 3 years old. The home visits focused solely on home safety topics, including crib safety. When infants were 2 weeks old, participants received a mailed packet with information on infant feeding.
Were any subgroups examined?
No
Subgroups examined
There were no subgroups reported in this manuscript.
Findings that rate moderate or high in this manuscript
| Outcome measure | Timing of follow-up | Rating | Direction of Effect | Effect size (absolute value) | Stastical significance | Sample size | Sample description | |
|---|---|---|---|---|---|---|---|---|
Bedtime routine: duration less than or equal to 45 minutes |
16 weeks old |
High | 0.35 | Statistically significant, p= 0.03 |
262 mother/child dyads | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Bedtime routine: read book |
16 weeks old |
High | 0.50 | Statistically significant, p <.01 |
262 mother/child dyads | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Bedtime routine: rocking |
16 weeks old |
High | 0.21 | Not statistically significant, p= 0.23 |
262 mother/child dyads | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Bedtime routine: bath |
16 weeks old |
High | 0.15 | Not statistically significant, p= 0.34 |
262 mother/child dyads | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Bedtime routine: music |
16 weeks old |
High | 0.06 | Not statistically significant, p= 0.57 |
262 mother/child dyads | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Bedtime routine: watch television |
16 weeks old |
High | 0.06 | Not statistically significant, p= 0.93 |
262 mother/child dyads | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Bedtime routine: bottle feed/breastfeed |
16 weeks old |
High | 0.34 | Not statistically significant, p= 0.16 |
262 mother/child dyads | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Bedtime routine: fed as last activity before bed |
16 weeks old |
High | 0.59 | Statistically significant, p <.01 |
262 mother/child dyads | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Bedtime routine: cereal in bottle |
16 weeks old |
High | 0.23 | Not statistically significant, p= 0.37 |
262 mother/child dyads | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Bedtime 8 PM or earlier |
16 weeks old |
High | 0.60 | Statistically significant, p <.01 |
262 infants | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Sleeps in own room |
16 weeks old |
High | 0.10 | Not statistically significant, p= 0.65 |
262 infants | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Falls asleep swaddled |
16 weeks old |
High | 0.41 | Statistically significant, p= 0.01 |
262 infants | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Falls asleep with pacifier |
16 weeks old |
High | 0.14 | Not statistically significant, p= 0.46 |
262 infants | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Falls asleep with white noise |
16 weeks old |
High | 0.15 | Not statistically significant, p= 0.42 |
262 infants | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Falls asleep being held |
16 weeks old |
High | 0.30 | Not statistically significant, p= 0.06 |
262 infants | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Falls asleep alone in room, in crib (self-soothes) |
16 weeks old |
High | 0.43 | Statistically significant, p= 0.01 |
262 infants | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Falls asleep in less than or equal to 15 minutes |
16 weeks old |
High | 0.28 | Not statistically significant, p= 0.07 |
262 infants | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Greater than or equal to 2 wakings per night |
16 weeks old |
High | 0.11 | Not statistically significant, p= 0.53 |
262 infants | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Greater than or equal to 2 night feedings |
16 weeks old |
High | 0.11 | Not statistically significant, p= 0.50 |
262 infants | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Night waking: give few minutes to fall back to sleep |
16 weeks old |
High | 0.27 | Not statistically significant, p= 0.09 |
262 mothers | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Night waking: pick up and hold/rock back to sleep |
16 weeks old |
High | 0.03 | Not statistically significant, p= 0.76 |
262 mothers | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Night waking: rub/pat but do not pick up |
16 weeks old |
High | 0.18 | Not statistically significant, p= 0.29 |
262 mothers | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Night waking: feed back to sleep |
16 weeks old |
High | 0.48 | Statistically significant, p <.01 |
262 mothers | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Night waking: give pacifier |
16 weeks old |
High | 0.08 | Not statistically significant, p= 0.50 |
262 mothers | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Night waking: change diaper |
16 weeks old |
High | 0.03 | Not statistically significant, p= 0.86 |
262 mothers | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Dream feeds: nighttime feeding initiated by parent |
16 weeks old |
High | 0.61 | Statistically significant, p <.01 |
262 mothers | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Bedtime routine: duration less than or equal to 45 minutes |
40 weeks old |
High | 0.32 | Statistically significant, p= 0.04 |
251 mother/child dyads | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Bedtime routine: read book |
40 weeks old |
High | 0.30 | Not statistically significant, p= 0.05 |
251 mother/child dyads | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Bedtime routine: rocking |
40 weeks old |
High | 0.00 | Not statistically significant, p= 0.89 |
251 mother/child dyads | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Bedtime routine: bath |
40 weeks old |
High | 0.08 | Not statistically significant, p= 0.65 |
251 mother/child dyads | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Bedtime routine: music |
40 weeks old |
High | 0.10 | Not statistically significant, p= 0.59 |
251 mother/child dyads | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Bedtime routine: watch television |
40 weeks old |
High | 0.36 | Not statistically significant, p= 0.13 |
251 mother/child dyads | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Bedtime routine: bottle feed/breastfeed |
40 weeks old |
High | 0.08 | Not statistically significant, p= 0.85 |
251 mother/child dyads | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Bedtime routine: fed as last activity before bed |
40 weeks old |
High | 0.34 | Not statistically significant, p= 0.05 |
251 mother/child dyads | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Bedtime routine: cereal in bottle |
40 weeks old |
High | 0.05 | Not statistically significant, p= 0.86 |
251 mother/child dyads | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Bedtime 8 PM or earlier |
40 weeks old |
High | 0.47 | Statistically significant, p <.01 |
251 infants | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Sleeps in own room |
40 weeks old |
High | 0.12 | Not statistically significant, p= 0.37 |
251 infants | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Falls asleep swaddled |
40 weeks old |
High | 0.43 | Not statistically significant, p= 0.57 |
251 infants | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Falls asleep with pacifier |
40 weeks old |
High | 0.08 | Not statistically significant, p= 0.66 |
251 infants | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Falls asleep with white noise |
40 weeks old |
High | 0.40 | Statistically significant, p= 0.02 |
251 infants | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Falls asleep being held |
40 weeks old |
High | 0.51 | Statistically significant, p <.01 |
251 infants | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Falls asleep alone in room, in crib (self-soothes) |
40 weeks old |
High | 0.32 | Statistically significant, p= 0.04 |
251 infants | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Falls asleep in less than or equal to 15 minutes |
40 weeks old |
High | 0.32 | Not statistically significant, p= 0.06 |
251 infants | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Greater than or equal to 2 wakings per night |
40 weeks old |
High | 0.12 | Not statistically significant, p= 0.50 |
251 infants | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Greater than or equal to 2 night feedings |
40 weeks old |
High | 0.05 | Not statistically significant, p= 0.70 |
251 infants | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Give few minutes to fall back to sleep |
40 weeks old |
High | 0.02 | Not statistically significant, p= 0.93 |
251 mothers | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Night waking: pick up and hold/rock back to sleep |
40 weeks old |
High | 0.38 | Statistically significant, p= 0.02 |
251 mothers | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Night waking: rub/pat but do not pick up |
40 weeks old |
High | 0.55 | Statistically significant, p <.01 |
251 mothers | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Night waking: feed back to sleep |
40 weeks old |
High | 0.48 | Statistically significant, p= 0.01 |
251 mothers | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Night waking: give pacifier |
40 weeks old |
High | 0.13 | Not statistically significant, p= 0.42 |
251 mothers | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Night waking: change diaper |
40 weeks old |
High | 0.05 | Not statistically significant, p= 0.82 |
251 mothers | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Dream feeds: nighttime feeding initiated by parent |
40 weeks old |
High | 0.67 | Statistically significant, p <.01 |
251 mothers | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Put to bed for the night while still awake |
8 weeks old |
High | 0.63 | Statistically significant, p <.01 |
257 infants | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Bedtime 8 PM or earlier |
1 year old |
High | 0.22 | Not statistically significant, p= 0.11 |
245 infants | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Same bedtime routine every night |
1 year old |
High | 0.52 | Statistically significant, p <.01 |
244 infants | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Bedtime Routines Questionnaire (BRQ): Overall score |
1 year old |
High | Statistically significant, p= 0.02 |
242 infants | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
|||
Bedtime Routines Questionnaire (BRQ): Routine Behaviors subscale |
1 year old |
High | Not statistically significant, p= 0.05 |
242 infants | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
|||
Bedtime Routines Questionnaire (BRQ): Routine Environment subscale |
1 year old |
High | Statistically significant, p= 0.03 |
242 infants | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
| Outcome measure | Timing of follow-up | Rating | Direction of Effect | Effect size (absolute value) | Stastical significance | Sample size | Sample description | |
|---|---|---|---|---|---|---|---|---|
Total daily sleep duration (minutes) |
8 weeks old |
High | 0.20 | Not statistically significant, p= 0.10 |
248 infants | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Overnight sleep duration (minutes) |
8 weeks old |
High | 0.42 | Statistically significant, p <.01 |
252 infants | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Total daily sleep duration (minutes) |
16 weeks old |
High | 0.21 | Not statistically significant, p= 0.08 |
262 infants | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Overnight sleep duration (minutes) |
16 weeks old |
High | 0.31 | Statistically significant, p= 0.01 |
262 infants | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Total daily sleep duration (minutes) |
40 weeks old |
High | Not statistically significant, p >.05 |
251 infants | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
|||
Overnight sleep duration (minutes) |
40 weeks old |
High | 0.30 | Statistically significant, p= 0.01 |
251 infants | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
||
Daytime sleep duration (minutes) |
8 weeks old |
High | Not statistically significant, p >.05 |
252 infants | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
|||
Daytime sleep duration (minutes) |
16 weeks old |
High | Not statistically significant, p >.05 |
262 infants | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
|||
Daytime sleep duration (minutes) |
40 weeks old |
High | Not statistically significant, p >.05 |
251 infants | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
|||
Daytime sleep duration (minutes) |
1 year old |
High | Not statistically significant, p >.05 |
245 infants | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
|||
Overnight sleep duration (minutes) |
1 year old |
High | Not statistically significant, p >.05 |
245 infants | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
|||
Sleep 12 to 14 hours per day |
1 year old |
High | 0.38 | Not statistically significant, p >.05 |
245 infants | INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample |
This study included participants with the following characteristics at enrollment:
Race/Ethnicity
Maternal Education
Other Characteristics
This study included participants from the following locations:
- Pennsylvania