Manuscript Details

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

Peer Reviewed

Model(s): Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT)
Study Registration: ClinicalTrials.gov
High rating
Study reviewed under: Handbook of Procedures and Standards, Version 2
Study design characteristics contributing to rating
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 from the review of this manuscript

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.

Child Health
Outcome Measure Timing of Follow-Up Rating Direction of Effect Effect Size (Absolute Value) Stastical Significance Sample Size Sample Description
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) 8 weeks old High
0.42 Statistically significant, p <.01 252 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
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
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
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
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
Total daily sleep duration (minutes) 40 weeks old High
Not statistically significant, p >.05 251 infants INSIGHT vs. comparison, Pennsylvania 2012-2014, full sample
Effect rating key
Favorable finding / Statistically significant
Unfavorable finding / Statistically significant
Ambiguous finding / Statistically significant
No effect / Not statistically significant
Positive Parenting Practices
Outcome Measure Timing of Follow-Up Rating Direction of Effect Effect Size (Absolute Value) Stastical Significance Sample Size Sample Description
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
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: 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: 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: 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: 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 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 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: 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: 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: 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: 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: 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: 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: 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 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: 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: 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: 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 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
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
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
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 being held 40 weeks old High
0.51 Statistically significant, p <.01 251 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
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
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 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 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 16 weeks old High
0.15 Not statistically significant, p= 0.42 262 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
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
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
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 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
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: change diaper 16 weeks old High
0.03 Not statistically significant, p= 0.86 262 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
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 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: 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: 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: 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: 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
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
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
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
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
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
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
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 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 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 white noise 40 weeks old High
0.40 Statistically significant, p= 0.02 251 infants 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
Effect rating key
Favorable finding / Statistically significant
Unfavorable finding / Statistically significant
Ambiguous finding / Statistically significant
No effect / Not statistically significant

Note: Tables do not include findings that HomVEE rated low or indeterminate, or found to be ineligible for review.

This study included participants with the following characteristics at enrollment:

Race/Ethnicity

The race and ethnicity categories may sum to more than 100 percent if Hispanic ethnicity was reported separately or respondents could select two or more race or ethnicity categories.

Asian
3%
Black or African American
6%
Hispanic or Latino
7%
Native Hawaiian or Pacific Islander
<1%
White
89%
Unknown
1%

Maternal Education

Some college or Associate's degree
26%
Bachelor's degree or higher
62%
Unknown
12%

Other Characteristics

Indigenous population
<1%

This study included participants from the following locations:

  • Pennsylvania
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.

Intervention condition
Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT)

Note: Navigate to the model page for more information about the home visiting model. See the source manuscript for more information about how the model was implemented in this study.

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.

Subgroups examined

There were no subgroups reported in this manuscript.

Author Affiliation

The authors are affiliated with several universities, including Pennsylvania State University, and are developers of the INSIGHT program.

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.