Trial Outcomes & Findings for Evaluation of a Novel Intervention for Infants At Risk for Neurodevelopmental Disorders (NCT NCT03388294)
NCT ID: NCT03388294
Last Updated: 2021-10-29
Results Overview
This system entails continuous coding of infants' attention engagement into one of 6 mutually exclusive states: unengaged, onlooking, object engaged, person-engaged, supported joint engagement, and coordinated joint engagement. Due to the importance of the construct of engagement to our PIE theory of change, the total percent of time in dyadic engagement (higher level supported + coordinated) will serve as the most proximal intervention outcome (i.e., changes expected at Posttest-1). Recent studies with children with NDs have shown that the coding system is sensitive to change in joint engagement after relatively short interventions.
COMPLETED
NA
72 participants
Baseline, Posttest 1 (6-8 weeks after baseline)
2021-10-29
Participant Flow
Unit of analysis: Dyads
Participant milestones
| Measure |
PC Followed by SR
Parents will first be coached to respond to their infant's pre-linguistic communication (PC) cues. After posttest 1, they will be coached in responding to the infant's sensory reactivity (SR) cues.
Parents and Infants Engaged (PIE): A parent coaching intervention addressing transactions between pre-linguistic communication and sensory reactivity in infants at-risk for autism and other neurodevelopmental disorders (NDs) on the one hand, and parent responses to infant cues on the other hand.
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SR Followed by PC
Parents will first be coached to respond to their infant's sensory reactivity (SR) cues. After posttest 1, they will be coached in responding to the infant's pre-linguistic communication (PC) cues.
Parents and Infants Engaged (PIE): A parent coaching intervention addressing transactions between pre-linguistic communication and sensory reactivity in infants at-risk for autism and other neurodevelopmental disorders (NDs) on the one hand, and parent responses to infant cues on the other hand.
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Overall Study
STARTED
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42 21
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30 15
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Overall Study
Posttest 1
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38 19
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30 15
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Overall Study
Posttest 2
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38 19
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30 15
|
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Overall Study
COMPLETED
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38 19
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30 15
|
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Overall Study
NOT COMPLETED
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4 2
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0 0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Parent age data unavailable.
Baseline characteristics by cohort
| Measure |
PC Followed by SR
n=21 Dyads
Using the PIE intervention, parents will first be coached to respond to their infant's pre-linguistic communication cues. After posttest 1, they will be coached in responding to the infant's sensory reactivity cues.
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SR Followed by PC
n=15 Dyads
Using the PIE intervention, parents will first be coached to respond to their infant's sensory reactivity cues. After posttest 1, they will be coached in responding to the infant's pre-linguistic communication cues.
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Total
n=36 Dyads
Total of all reporting groups
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|---|---|---|---|
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Age, Customized
Infant age
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13.95 Months
STANDARD_DEVIATION 1.66 • n=21 Participants • Parent age data unavailable.
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14.07 Months
STANDARD_DEVIATION 1.67 • n=15 Participants • Parent age data unavailable.
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14.00 Months
STANDARD_DEVIATION 1.64 • n=36 Participants • Parent age data unavailable.
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Sex: Female, Male
Infants · Female
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7 Participants
n=21 Participants • Gender reported separately for parent/caregiver and infants.
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3 Participants
n=15 Participants • Gender reported separately for parent/caregiver and infants.
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10 Participants
n=36 Participants • Gender reported separately for parent/caregiver and infants.
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Sex: Female, Male
Infants · Male
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14 Participants
n=21 Participants • Gender reported separately for parent/caregiver and infants.
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12 Participants
n=15 Participants • Gender reported separately for parent/caregiver and infants.
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26 Participants
n=36 Participants • Gender reported separately for parent/caregiver and infants.
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Sex: Female, Male
Parents/Caregivers · Female
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17 Participants
n=21 Participants • Gender reported separately for parent/caregiver and infants.
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14 Participants
n=15 Participants • Gender reported separately for parent/caregiver and infants.
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31 Participants
n=36 Participants • Gender reported separately for parent/caregiver and infants.
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Sex: Female, Male
Parents/Caregivers · Male
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4 Participants
n=21 Participants • Gender reported separately for parent/caregiver and infants.
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1 Participants
n=15 Participants • Gender reported separately for parent/caregiver and infants.
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5 Participants
n=36 Participants • Gender reported separately for parent/caregiver and infants.
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Ethnicity (NIH/OMB)
Infants · Hispanic or Latino
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5 Participants
n=21 Participants • Data reported separately for parent/caregiver and infants.
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2 Participants
n=15 Participants • Data reported separately for parent/caregiver and infants.
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7 Participants
n=36 Participants • Data reported separately for parent/caregiver and infants.
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Ethnicity (NIH/OMB)
Infants · Not Hispanic or Latino
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15 Participants
n=21 Participants • Data reported separately for parent/caregiver and infants.
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13 Participants
n=15 Participants • Data reported separately for parent/caregiver and infants.
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28 Participants
n=36 Participants • Data reported separately for parent/caregiver and infants.
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Ethnicity (NIH/OMB)
Infants · Unknown or Not Reported
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1 Participants
n=21 Participants • Data reported separately for parent/caregiver and infants.
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0 Participants
n=15 Participants • Data reported separately for parent/caregiver and infants.
|
1 Participants
n=36 Participants • Data reported separately for parent/caregiver and infants.
|
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Ethnicity (NIH/OMB)
Parents/Caregivers · Hispanic or Latino
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3 Participants
n=21 Participants • Data reported separately for parent/caregiver and infants.
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3 Participants
n=15 Participants • Data reported separately for parent/caregiver and infants.
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6 Participants
n=36 Participants • Data reported separately for parent/caregiver and infants.
|
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Ethnicity (NIH/OMB)
Parents/Caregivers · Not Hispanic or Latino
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14 Participants
n=21 Participants • Data reported separately for parent/caregiver and infants.
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10 Participants
n=15 Participants • Data reported separately for parent/caregiver and infants.
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24 Participants
n=36 Participants • Data reported separately for parent/caregiver and infants.
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Ethnicity (NIH/OMB)
Parents/Caregivers · Unknown or Not Reported
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4 Participants
n=21 Participants • Data reported separately for parent/caregiver and infants.
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2 Participants
n=15 Participants • Data reported separately for parent/caregiver and infants.
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6 Participants
n=36 Participants • Data reported separately for parent/caregiver and infants.
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Race (NIH/OMB)
Infants · American Indian or Alaska Native
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0 Participants
n=21 Participants • Race reported separately for parent/caregiver and infants.
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0 Participants
n=15 Participants • Race reported separately for parent/caregiver and infants.
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0 Participants
n=36 Participants • Race reported separately for parent/caregiver and infants.
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Race (NIH/OMB)
Infants · Asian
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1 Participants
n=21 Participants • Race reported separately for parent/caregiver and infants.
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1 Participants
n=15 Participants • Race reported separately for parent/caregiver and infants.
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2 Participants
n=36 Participants • Race reported separately for parent/caregiver and infants.
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Race (NIH/OMB)
Infants · Native Hawaiian or Other Pacific Islander
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0 Participants
n=21 Participants • Race reported separately for parent/caregiver and infants.
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0 Participants
n=15 Participants • Race reported separately for parent/caregiver and infants.
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0 Participants
n=36 Participants • Race reported separately for parent/caregiver and infants.
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Race (NIH/OMB)
Infants · Black or African American
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2 Participants
n=21 Participants • Race reported separately for parent/caregiver and infants.
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2 Participants
n=15 Participants • Race reported separately for parent/caregiver and infants.
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4 Participants
n=36 Participants • Race reported separately for parent/caregiver and infants.
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Race (NIH/OMB)
Infants · White
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13 Participants
n=21 Participants • Race reported separately for parent/caregiver and infants.
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12 Participants
n=15 Participants • Race reported separately for parent/caregiver and infants.
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25 Participants
n=36 Participants • Race reported separately for parent/caregiver and infants.
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Race (NIH/OMB)
Infants · More than one race
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3 Participants
n=21 Participants • Race reported separately for parent/caregiver and infants.
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0 Participants
n=15 Participants • Race reported separately for parent/caregiver and infants.
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3 Participants
n=36 Participants • Race reported separately for parent/caregiver and infants.
|
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Race (NIH/OMB)
Infants · Unknown or Not Reported
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2 Participants
n=21 Participants • Race reported separately for parent/caregiver and infants.
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0 Participants
n=15 Participants • Race reported separately for parent/caregiver and infants.
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2 Participants
n=36 Participants • Race reported separately for parent/caregiver and infants.
|
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Race (NIH/OMB)
Parents/Caregivers · American Indian or Alaska Native
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1 Participants
n=21 Participants • Race reported separately for parent/caregiver and infants.
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0 Participants
n=15 Participants • Race reported separately for parent/caregiver and infants.
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1 Participants
n=36 Participants • Race reported separately for parent/caregiver and infants.
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Race (NIH/OMB)
Parents/Caregivers · Asian
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1 Participants
n=21 Participants • Race reported separately for parent/caregiver and infants.
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0 Participants
n=15 Participants • Race reported separately for parent/caregiver and infants.
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1 Participants
n=36 Participants • Race reported separately for parent/caregiver and infants.
|
|
Race (NIH/OMB)
Parents/Caregivers · Native Hawaiian or Other Pacific Islander
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0 Participants
n=21 Participants • Race reported separately for parent/caregiver and infants.
|
0 Participants
n=15 Participants • Race reported separately for parent/caregiver and infants.
|
0 Participants
n=36 Participants • Race reported separately for parent/caregiver and infants.
|
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Race (NIH/OMB)
Parents/Caregivers · Black or African American
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1 Participants
n=21 Participants • Race reported separately for parent/caregiver and infants.
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1 Participants
n=15 Participants • Race reported separately for parent/caregiver and infants.
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2 Participants
n=36 Participants • Race reported separately for parent/caregiver and infants.
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Race (NIH/OMB)
Parents/Caregivers · White
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12 Participants
n=21 Participants • Race reported separately for parent/caregiver and infants.
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11 Participants
n=15 Participants • Race reported separately for parent/caregiver and infants.
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23 Participants
n=36 Participants • Race reported separately for parent/caregiver and infants.
|
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Race (NIH/OMB)
Parents/Caregivers · More than one race
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2 Participants
n=21 Participants • Race reported separately for parent/caregiver and infants.
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0 Participants
n=15 Participants • Race reported separately for parent/caregiver and infants.
|
2 Participants
n=36 Participants • Race reported separately for parent/caregiver and infants.
|
|
Race (NIH/OMB)
Parents/Caregivers · Unknown or Not Reported
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4 Participants
n=21 Participants • Race reported separately for parent/caregiver and infants.
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3 Participants
n=15 Participants • Race reported separately for parent/caregiver and infants.
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7 Participants
n=36 Participants • Race reported separately for parent/caregiver and infants.
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Region of Enrollment
United States
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42 Participants
n=42 Participants
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30 Participants
n=30 Participants
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72 Participants
n=72 Participants
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PRIMARY outcome
Timeframe: Baseline, Posttest 1 (6-8 weeks after baseline)Population: Four dyads in the PC followed by SR and 1 dyad in the SR followed by PC were unavailable at Posttest 1
This system entails continuous coding of infants' attention engagement into one of 6 mutually exclusive states: unengaged, onlooking, object engaged, person-engaged, supported joint engagement, and coordinated joint engagement. Due to the importance of the construct of engagement to our PIE theory of change, the total percent of time in dyadic engagement (higher level supported + coordinated) will serve as the most proximal intervention outcome (i.e., changes expected at Posttest-1). Recent studies with children with NDs have shown that the coding system is sensitive to change in joint engagement after relatively short interventions.
Outcome measures
| Measure |
PC Followed by SR
n=21 Dyads
Using the PIE intervention, parents will first be coached to respond to their infant's pre-linguistic communication cues. After posttest 1, they will be coached in responding to the infant's sensory reactivity cues.
|
SR Followed by PC
n=15 Dyads
Using the PIE intervention, parents will first be coached to respond to their infant's sensory reactivity cues. After posttest 1, they will be coached in responding to the infant's pre-linguistic communication cues.
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|---|---|---|
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Change in Mean Percent of Parent Child Dyadic Engagement Over Time From Baseline to Posttest 1
Posttest 1
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26.55 percent time in dyadic engagement
Standard Deviation 14.62
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27.09 percent time in dyadic engagement
Standard Deviation 7.81
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Change in Mean Percent of Parent Child Dyadic Engagement Over Time From Baseline to Posttest 1
Baseline
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22.01 percent time in dyadic engagement
Standard Deviation 13.63
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16.91 percent time in dyadic engagement
Standard Deviation 9.70
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PRIMARY outcome
Timeframe: Baseline, Posttest 2 (13-16 weeks after baseline)Population: Three dyads in the PC followed by SR and 2 dyads in the SR followed by PC were unavailable at Posttest 2
This system entails continuous coding of infants' attention engagement into one of 6 mutually exclusive states: unengaged, onlooking, object engaged, person-engaged, supported joint engagement, and coordinated joint engagement. Due to the importance of the construct of engagement to our PIE theory of change, the total percent of time in dyadic engagement (higher level supported + coordinated) will serve as the most proximal intervention outcome (i.e., changes expected at Posttest-1). Recent studies with children with NDs have shown that the coding system is sensitive to change in joint engagement after relatively short interventions.
Outcome measures
| Measure |
PC Followed by SR
n=21 Dyads
Using the PIE intervention, parents will first be coached to respond to their infant's pre-linguistic communication cues. After posttest 1, they will be coached in responding to the infant's sensory reactivity cues.
|
SR Followed by PC
n=15 Dyads
Using the PIE intervention, parents will first be coached to respond to their infant's sensory reactivity cues. After posttest 1, they will be coached in responding to the infant's pre-linguistic communication cues.
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|---|---|---|
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Change in Mean Percent of Parent Child Dyadic Engagement Over Time From Baseline to Posttest 2
Posttest 2
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30.12 percent time in dyadic engagement
Standard Deviation 16.78
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35.23 percent time in dyadic engagement
Standard Deviation 22.12
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Change in Mean Percent of Parent Child Dyadic Engagement Over Time From Baseline to Posttest 2
Baseline
|
22.01 percent time in dyadic engagement
Standard Deviation 13.63
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16.91 percent time in dyadic engagement
Standard Deviation 9.70
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SECONDARY outcome
Timeframe: Baseline, Posttest 1 (6-8 weeks after baseline)Population: Data for 1 enrolled parent was unavailable at Baseline and data 3 enrolled parents were unavailable at Posttest 1
Parent-child interaction videos will be coded for parent responsiveness to child sensory reactivity cues. These are each rated on a 0-7 scale. Higher scores indicate greater responsivity from parents.
Outcome measures
| Measure |
PC Followed by SR
n=20 Participants
Using the PIE intervention, parents will first be coached to respond to their infant's pre-linguistic communication cues. After posttest 1, they will be coached in responding to the infant's sensory reactivity cues.
|
SR Followed by PC
n=15 Participants
Using the PIE intervention, parents will first be coached to respond to their infant's sensory reactivity cues. After posttest 1, they will be coached in responding to the infant's pre-linguistic communication cues.
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|---|---|---|
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Change in Rating of Parent Responsiveness to Child Sensory Reactivity Cues From Baseline to Posttest 1
Baseline
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3.73 score on a scale
Standard Deviation 1.15
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3.47 score on a scale
Standard Deviation 0.76
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Change in Rating of Parent Responsiveness to Child Sensory Reactivity Cues From Baseline to Posttest 1
Posttest 1
|
4.33 score on a scale
Standard Deviation 0.98
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4.02 score on a scale
Standard Deviation 1.35
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SECONDARY outcome
Timeframe: Baseline, posttest 2 (13-16 weeks after baseline)Population: Data for 1 enrolled parent was unavailable at Baseline and data 3 enrolled parents were unavailable at Posttest 2
Parent-child interaction videos will be coded for parent responsiveness to child sensory reactivity cues. These are each rated on a 0-7 scale. Higher scores indicate greater responsivity from parents.
Outcome measures
| Measure |
PC Followed by SR
n=20 Participants
Using the PIE intervention, parents will first be coached to respond to their infant's pre-linguistic communication cues. After posttest 1, they will be coached in responding to the infant's sensory reactivity cues.
|
SR Followed by PC
n=15 Participants
Using the PIE intervention, parents will first be coached to respond to their infant's sensory reactivity cues. After posttest 1, they will be coached in responding to the infant's pre-linguistic communication cues.
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|---|---|---|
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Change in Rating of Parent Responsiveness to Child Sensory Reactivity Cues From Baseline to Posttest 2
Posttest 2
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4.03 score on a scale
Standard Deviation 0.93
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4.39 score on a scale
Standard Deviation 1.21
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Change in Rating of Parent Responsiveness to Child Sensory Reactivity Cues From Baseline to Posttest 2
Baseline
|
3.73 score on a scale
Standard Deviation 1.15
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3.47 score on a scale
Standard Deviation 0.76
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SECONDARY outcome
Timeframe: Baseline, Posttest 1 (6-8 weeks after pretest)Population: Data for 4 enrolled parents was unavailable at Posttest 1
Parent-child interaction videos will be coded for parent responsiveness to child prelinguistic communication cues. These are each rated on a 0-7 scale. Higher scores indicate greater responsivity from parents.
Outcome measures
| Measure |
PC Followed by SR
n=21 Participants
Using the PIE intervention, parents will first be coached to respond to their infant's pre-linguistic communication cues. After posttest 1, they will be coached in responding to the infant's sensory reactivity cues.
|
SR Followed by PC
n=15 Participants
Using the PIE intervention, parents will first be coached to respond to their infant's sensory reactivity cues. After posttest 1, they will be coached in responding to the infant's pre-linguistic communication cues.
|
|---|---|---|
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Change in Rating of Parent Responsiveness to Child Prelinguistic Communication Cues From Baseline to Posttest 1
Baseline
|
4.04 score on a scale
Standard Deviation 0.90
|
4.57 score on a scale
Standard Deviation 1.23
|
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Change in Rating of Parent Responsiveness to Child Prelinguistic Communication Cues From Baseline to Posttest 1
Posttest 1
|
4.54 score on a scale
Standard Deviation 0.97
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4.88 score on a scale
Standard Deviation 0.92
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SECONDARY outcome
Timeframe: Baseline, Posttest 2 (13-16 weeks after baseline)Population: Data for 4 enrolled parents was unavailable at Posttest 2
Parent-child interaction videos will be coded for parent responsiveness to child prelinguistic communication cues. These are each rated on a 0-7 scale. Higher scores indicate greater responsivity from parents.
Outcome measures
| Measure |
PC Followed by SR
n=21 Participants
Using the PIE intervention, parents will first be coached to respond to their infant's pre-linguistic communication cues. After posttest 1, they will be coached in responding to the infant's sensory reactivity cues.
|
SR Followed by PC
n=15 Participants
Using the PIE intervention, parents will first be coached to respond to their infant's sensory reactivity cues. After posttest 1, they will be coached in responding to the infant's pre-linguistic communication cues.
|
|---|---|---|
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Change in Rating of Parent Responsiveness to Child Prelinguistic Communication Cues From Baseline to Posttest 2
Baseline
|
4.04 score on a scale
Standard Deviation 0.90
|
4.57 score on a scale
Standard Deviation 1.23
|
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Change in Rating of Parent Responsiveness to Child Prelinguistic Communication Cues From Baseline to Posttest 2
Posttest 2
|
4.39 score on a scale
Standard Deviation 1.06
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4.32 score on a scale
Standard Deviation 0.95
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SECONDARY outcome
Timeframe: Baseline, Posttest 1 (6-8 weeks after pretest)Population: Data for 3 enrolled children was unavailable at Posttest 1
Rate of child intentional communication during parent-child interaction, coded from videos. Video recordings of parent-child interactions were coded for infants' intentional communication acts (i.e., acts directed to the parent): vocalizations, gestures, or both (acts combining vocalizations and gestures). A total acts variable was calculated for the sum of all communication acts in a recording. The total communication acts variable was transformed into a rate variable (instances per minute) for the purpose of this outcome.
Outcome measures
| Measure |
PC Followed by SR
n=21 Participants
Using the PIE intervention, parents will first be coached to respond to their infant's pre-linguistic communication cues. After posttest 1, they will be coached in responding to the infant's sensory reactivity cues.
|
SR Followed by PC
n=15 Participants
Using the PIE intervention, parents will first be coached to respond to their infant's sensory reactivity cues. After posttest 1, they will be coached in responding to the infant's pre-linguistic communication cues.
|
|---|---|---|
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Change in Rate of Infant Intentional Communication Over Time, Baseline to Posttest 1
Baseline
|
0.48 instances per minute
Standard Deviation 0.44
|
0.48 instances per minute
Standard Deviation 0.38
|
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Change in Rate of Infant Intentional Communication Over Time, Baseline to Posttest 1
Posttest 1
|
0.71 instances per minute
Standard Deviation 0.64
|
0.67 instances per minute
Standard Deviation 0.66
|
SECONDARY outcome
Timeframe: Baseline, Posttest 2 (13-16 weeks after pretest)Population: Data for 4 enrolled children were unavailable for Posttest 2
Rate of infant intentional communication during parent-child interaction, coded from videos. Video recordings of parent-child interactions were coded for infants' intentional communication acts (i.e., acts directed to the parent): vocalizations, gestures, or both (acts combining vocalizations and gestures). A total acts variable was calculated for the sum of all communication acts in a recording. The total communication acts variable was transformed into a rate variable (instances per minute) for the purpose of this outcome.
Outcome measures
| Measure |
PC Followed by SR
n=21 Participants
Using the PIE intervention, parents will first be coached to respond to their infant's pre-linguistic communication cues. After posttest 1, they will be coached in responding to the infant's sensory reactivity cues.
|
SR Followed by PC
n=15 Participants
Using the PIE intervention, parents will first be coached to respond to their infant's sensory reactivity cues. After posttest 1, they will be coached in responding to the infant's pre-linguistic communication cues.
|
|---|---|---|
|
Change in Rate of Infant Intentional Communication Over Time, Baseline to Posttest 2
Baseline
|
0.48 instances per minute
Standard Deviation 0.44
|
0.48 instances per minute
Standard Deviation 0.38
|
|
Change in Rate of Infant Intentional Communication Over Time, Baseline to Posttest 2
Posttest 2
|
0.92 instances per minute
Standard Deviation 0.53
|
1.03 instances per minute
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: Baseline, Posttest 2 (13-16 weeks after baseline)Population: Due to challenges getting infants to keep electrodes attached or remain still during procedure, some did not have data available for Baseline but did have data for Posttest 2 and vice versa. Data were unavailable for 15 enrolled children at Baseline and 21 enrolled children for Posttest 2.
Respiratory Sinus Arrhythmia (RSA) levels will be collected using a standard protocol while the child is seated in a high chair exposed to social and non-social stimuli. RSA indexes the variability in heartrate that is associated with respiratory inspiration and expiration. RSA levels are expected to increase with development during exposure to both social and nonsocial stimuli in the context of this protocol. Higher RSA levels during exposure to social stimuli involving child-directed speech have been predictive of better language outcomes in previous studies of preschoolers diagnosed with autism.
Outcome measures
| Measure |
PC Followed by SR
n=19 Participants
Using the PIE intervention, parents will first be coached to respond to their infant's pre-linguistic communication cues. After posttest 1, they will be coached in responding to the infant's sensory reactivity cues.
|
SR Followed by PC
n=10 Participants
Using the PIE intervention, parents will first be coached to respond to their infant's sensory reactivity cues. After posttest 1, they will be coached in responding to the infant's pre-linguistic communication cues.
|
|---|---|---|
|
Change in Respiratory Sinus Arrhythmia From Baseline to Posttest 2 During Social Stimuli
Baseline
|
4.07 ln(ms^2)
Standard Deviation 1.07
|
4.54 ln(ms^2)
Standard Deviation 0.94
|
|
Change in Respiratory Sinus Arrhythmia From Baseline to Posttest 2 During Social Stimuli
Posttest 2
|
4.52 ln(ms^2)
Standard Deviation 1.19
|
4.25 ln(ms^2)
Standard Deviation 1.07
|
SECONDARY outcome
Timeframe: Baseline, Posttest 2 (13-16 weeks after baseline)Population: Due to challenges getting infants to keep electrodes attached or remain still during procedure, some did not have data available for Baseline but did have data for Posttest 2 and vice versa. Data were unavailable for 15 enrolled children at Baseline and 20 enrolled children for Posttest 2.
Respiratory Sinus Arrhythmia (RSA) levels will be collected using a standard protocol while the child is seated in a high chair exposed to social and non-social stimuli. RSA indexes the variability in heartrate that is associated with respiratory inspiration and expiration. RSA levels are expected to increase with development during exposure to both social and nonsocial stimuli in the context of this protocol. Higher RSA levels during exposure to social stimuli involving child-directed speech have been predictive of better language outcomes in previous studies of preschoolers diagnosed with autism.
Outcome measures
| Measure |
PC Followed by SR
n=19 Participants
Using the PIE intervention, parents will first be coached to respond to their infant's pre-linguistic communication cues. After posttest 1, they will be coached in responding to the infant's sensory reactivity cues.
|
SR Followed by PC
n=10 Participants
Using the PIE intervention, parents will first be coached to respond to their infant's sensory reactivity cues. After posttest 1, they will be coached in responding to the infant's pre-linguistic communication cues.
|
|---|---|---|
|
Change in Respiratory Sinus Arrhythmia From Baseline to Posttest 2 During Non-Social Stimuli
Baseline
|
3.81 ln(ms^2)
Standard Deviation 0.96
|
4.24 ln(ms^2)
Standard Deviation 1.10
|
|
Change in Respiratory Sinus Arrhythmia From Baseline to Posttest 2 During Non-Social Stimuli
Posttest 2
|
4.36 ln(ms^2)
Standard Deviation 1.35
|
3.61 ln(ms^2)
Standard Deviation 4.24
|
SECONDARY outcome
Timeframe: Baseline, Posttest 2 (13-16 weeks after baseline)Population: Excessive movement artifacts in skin conductance data prevented derivation of valid skin conductance levels from children
Skin conductance levels will be collected using a standard protocol while the child is seated in a high chair exposed to social and non-social stimuli.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Posttest 2 (13-16 weeks after baseline)Population: Some video durations were too short to qualify for scoring per BOSCC protocol. Data were unavailable for 7 enrolled children at Baseline and 8 enrolled children for Posttest 2. The majority of enrolled children (i.e., 25) had data available at both timepoints; 4 enrolled children had data at Baseline only; 3 enrolled children at Posttest 2 only; and 4 enrolled children had no data available at either timepoint.
A treatment response measure of social communication behaviors and other behaviors associated with autism spectrum disorder (ASD). Administration of the BOSCC involves a 12-minute video recorded interaction between an examiner and a young child using two standard sets of toys and play with bubbles. Behaviors are coded from video. Total score range is 16-80. Higher scores indicate more atypical social communication skills, lower scores indicate better skills.
Outcome measures
| Measure |
PC Followed by SR
n=18 Participants
Using the PIE intervention, parents will first be coached to respond to their infant's pre-linguistic communication cues. After posttest 1, they will be coached in responding to the infant's sensory reactivity cues.
|
SR Followed by PC
n=14 Participants
Using the PIE intervention, parents will first be coached to respond to their infant's sensory reactivity cues. After posttest 1, they will be coached in responding to the infant's pre-linguistic communication cues.
|
|---|---|---|
|
Change in The Behavioral Observation of Social Communication Change (BOSCC) From Baseline to Posttest 2
Baseline
|
34.06 score on a scale
Standard Deviation 4.17
|
30.96 score on a scale
Standard Deviation 5.22
|
|
Change in The Behavioral Observation of Social Communication Change (BOSCC) From Baseline to Posttest 2
Posttest 2
|
29.40 score on a scale
Standard Deviation 6.47
|
29.62 score on a scale
Standard Deviation 6.83
|
SECONDARY outcome
Timeframe: Baseline, Posttest 2 (13-16 weeks after baseline)Population: Data were unavailable for enrolled child at Baseline and 4 enrolled children at Posttest 2
Designed to measure the extent to which children will follow attentional cues of the examiner. Six prompts for attention following are embedded into the larger study protocol. Items are scored dichotomously as yes "1" or no "0".Total score range is 0-6. Higher scores indicate more typical responses to bids for joint attention.
Outcome measures
| Measure |
PC Followed by SR
n=21 Participants
Using the PIE intervention, parents will first be coached to respond to their infant's pre-linguistic communication cues. After posttest 1, they will be coached in responding to the infant's sensory reactivity cues.
|
SR Followed by PC
n=14 Participants
Using the PIE intervention, parents will first be coached to respond to their infant's sensory reactivity cues. After posttest 1, they will be coached in responding to the infant's pre-linguistic communication cues.
|
|---|---|---|
|
Change in The Attention Following Protocol (AF Protocol) From Baseline to Posttest 2
Baseline
|
2.14 score on a scale
Standard Deviation 2.08
|
2.93 score on a scale
Standard Deviation 2.37
|
|
Change in The Attention Following Protocol (AF Protocol) From Baseline to Posttest 2
Posttest 2
|
3.78 score on a scale
Standard Deviation 2.34
|
4.00 score on a scale
Standard Deviation 2.25
|
SECONDARY outcome
Timeframe: Baseline, Posttest 2 (13-16 weeks after baseline)Population: Data were unavailable for 4 enrolled children at Posttest 2
The Mullen Scales of Early Learning (MSEL) is a standardized developmental assessment for children birth to 58 months, frequently used in studies of children with NDs, This outcome comprises changes in standardized T-scores (Mean = 50, SD = 10) on the MSEL Receptive Language scale. Higher scores indicate greater developmental skills.
Outcome measures
| Measure |
PC Followed by SR
n=21 Participants
Using the PIE intervention, parents will first be coached to respond to their infant's pre-linguistic communication cues. After posttest 1, they will be coached in responding to the infant's sensory reactivity cues.
|
SR Followed by PC
n=15 Participants
Using the PIE intervention, parents will first be coached to respond to their infant's sensory reactivity cues. After posttest 1, they will be coached in responding to the infant's pre-linguistic communication cues.
|
|---|---|---|
|
Change in Mullen Scales of Early Learning Receptive Language T-Scores From Baseline to Posttest 2
Baseline
|
30.19 score on a scale
Standard Deviation 8.73
|
34.33 score on a scale
Standard Deviation 12.72
|
|
Change in Mullen Scales of Early Learning Receptive Language T-Scores From Baseline to Posttest 2
Posttest 2
|
30.56 score on a scale
Standard Deviation 10.89
|
33.71 score on a scale
Standard Deviation 13.79
|
SECONDARY outcome
Timeframe: Baseline, posttest 2 (13-16 weeks after baseline)Population: Data were unavailable for 4 enrolled children at Posttest 2
The MSEL is a standardized developmental assessment for children birth to 58 months, frequently used in studies of children with NDs, This outcome comprises changes in standardized T-scores (Mean = 50, SD = 10) on the MSEL Expressive Language scale. Higher scores indicate greater developmental skills.
Outcome measures
| Measure |
PC Followed by SR
n=21 Participants
Using the PIE intervention, parents will first be coached to respond to their infant's pre-linguistic communication cues. After posttest 1, they will be coached in responding to the infant's sensory reactivity cues.
|
SR Followed by PC
n=15 Participants
Using the PIE intervention, parents will first be coached to respond to their infant's sensory reactivity cues. After posttest 1, they will be coached in responding to the infant's pre-linguistic communication cues.
|
|---|---|---|
|
Change in Mullen Scales of Early Learning Expressive Language T-scores From Baseline to Posttest 2
Posttest 2
|
34.06 score on a scale
Standard Deviation 9.36
|
37.29 score on a scale
Standard Deviation 11.92
|
|
Change in Mullen Scales of Early Learning Expressive Language T-scores From Baseline to Posttest 2
Baseline
|
32.38 score on a scale
Standard Deviation 8.84
|
32.93 score on a scale
Standard Deviation 11.11
|
SECONDARY outcome
Timeframe: Baseline, posttest 2 (13-16 weeks after baseline)Population: Data were unavailable for 4 enrolled children at Baseline and 6 enrolled children at Posttest 2
A play-based assessment used to measure children's approach-avoidance to novel sensory toys (i.e., hyper-reactivity) and orienting responses (i.e., hypo-reactivity) across three sensory modalities (auditory, visual, tactile). The investigators will report a mean score for Hypo (range = 1-5) and Hyper (range = 1-5) sensory subscales. Higher scores indicate greater sensory differences in that domain (e.g. a high hypo domain score would indicate more hyposensitive reactions to sensory stimuli seen in the child).
Outcome measures
| Measure |
PC Followed by SR
n=21 Participants
Using the PIE intervention, parents will first be coached to respond to their infant's pre-linguistic communication cues. After posttest 1, they will be coached in responding to the infant's sensory reactivity cues.
|
SR Followed by PC
n=15 Participants
Using the PIE intervention, parents will first be coached to respond to their infant's sensory reactivity cues. After posttest 1, they will be coached in responding to the infant's pre-linguistic communication cues.
|
|---|---|---|
|
Change in Sensory Processing Assessment for Young Children From Baseline to Posttest 2 in Hypo-Reactivity
Baseline
|
2.58 score on a scale
Standard Deviation 0.68
|
2.10 score on a scale
Standard Deviation 0.85
|
|
Change in Sensory Processing Assessment for Young Children From Baseline to Posttest 2 in Hypo-Reactivity
Posttest 2
|
2.61 score on a scale
Standard Deviation 0.91
|
1.99 score on a scale
Standard Deviation 0.72
|
SECONDARY outcome
Timeframe: Baseline, posttest 2 (13-16 weeks after baseline)Population: Data were unavailable for 4 enrolled children at Baseline and 6 enrolled children at Posttest 2
A play-based assessment used to measure children's approach-avoidance to novel sensory toys (i.e., hyper-reactivity) and orienting responses (i.e., hypo-reactivity) across three sensory modalities (auditory, visual, tactile). The investigators will report a mean score for Hypo (range = 1-5) and Hyper (range = 1-5) sensory subscales. Higher scores indicate greater sensory differences in that domain (e.g. a high hypo domain score would indicate more hyposensitive reactions to sensory stimuli seen in the child).
Outcome measures
| Measure |
PC Followed by SR
n=21 Participants
Using the PIE intervention, parents will first be coached to respond to their infant's pre-linguistic communication cues. After posttest 1, they will be coached in responding to the infant's sensory reactivity cues.
|
SR Followed by PC
n=15 Participants
Using the PIE intervention, parents will first be coached to respond to their infant's sensory reactivity cues. After posttest 1, they will be coached in responding to the infant's pre-linguistic communication cues.
|
|---|---|---|
|
Change in Sensory Processing Assessment for Young Children From Baseline to Posttest 2 in Hyper-Reactivity
Baseline
|
1.66 score on a scale
Standard Deviation 0.39
|
1.55 score on a scale
Standard Deviation 0.40
|
|
Change in Sensory Processing Assessment for Young Children From Baseline to Posttest 2 in Hyper-Reactivity
Posttest 2
|
1.59 score on a scale
Standard Deviation 0.33
|
1.59 score on a scale
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: Baseline, posttest 1 (6-8 weeks after baseline)Population: No data are available for 3 enrolled children at Baseline and 16 at Posttest 1.
A 43 item parent questionnaire that asks about the child's responses to various sensory stimuli in the context of functional activities and daily routines in the child's environment. It also documents strategies parents use to respond to their child's behaviors. Hyper and Hypo mean domain scores will be reported (range = 1-5). Greater domain scores indicate a greater presence of that type of sensory response.
Outcome measures
| Measure |
PC Followed by SR
n=21 Participants
Using the PIE intervention, parents will first be coached to respond to their infant's pre-linguistic communication cues. After posttest 1, they will be coached in responding to the infant's sensory reactivity cues.
|
SR Followed by PC
n=15 Participants
Using the PIE intervention, parents will first be coached to respond to their infant's sensory reactivity cues. After posttest 1, they will be coached in responding to the infant's pre-linguistic communication cues.
|
|---|---|---|
|
Change in The Sensory Experiences Questionnaire Version 2.1 From Baseline to Posttest 1 in Hypo-reactivity
Baseline
|
2.18 score on a scale
Standard Deviation 0.62
|
1.92 score on a scale
Standard Deviation 0.69
|
|
Change in The Sensory Experiences Questionnaire Version 2.1 From Baseline to Posttest 1 in Hypo-reactivity
Posttest 1
|
2.26 score on a scale
Standard Deviation 0.57
|
2.04 score on a scale
Standard Deviation 0.74
|
SECONDARY outcome
Timeframe: Baseline, posttest 1 (6-8 weeks after baseline)Population: Data were unavailable for 3 enrolled children at Baseline and 16 at Posttest 1
A 43 item parent questionnaire that asks about the child's responses to various sensory stimuli in the context of functional activities and daily routines in the child's environment. It also documents strategies parents use to respond to their child's behaviors. Hyper and Hypo mean domain scores will be reported (range = 1-5). Greater domain scores indicate a greater presence of that type of sensory response.
Outcome measures
| Measure |
PC Followed by SR
n=21 Participants
Using the PIE intervention, parents will first be coached to respond to their infant's pre-linguistic communication cues. After posttest 1, they will be coached in responding to the infant's sensory reactivity cues.
|
SR Followed by PC
n=15 Participants
Using the PIE intervention, parents will first be coached to respond to their infant's sensory reactivity cues. After posttest 1, they will be coached in responding to the infant's pre-linguistic communication cues.
|
|---|---|---|
|
Change in The Sensory Experiences Questionnaire Version 2.1 From Baseline to Posttest 1 in Hyper-reactivity
Baseline
|
2.03 score on a scale
Standard Deviation 0.34
|
1.81 score on a scale
Standard Deviation 0.33
|
|
Change in The Sensory Experiences Questionnaire Version 2.1 From Baseline to Posttest 1 in Hyper-reactivity
Posttest 1
|
1.92 score on a scale
Standard Deviation 0.39
|
1.85 score on a scale
Standard Deviation 0.29
|
SECONDARY outcome
Timeframe: Baseline, posttest 2 (13-16 weeks after baseline)Population: Data were unavailable for 3 enrolled participants at Baseline and 16 at Posttest 2.
A 43 item parent questionnaire that asks about the child's responses to various sensory stimuli in the context of functional activities and daily routines in the child's environment. It also documents strategies parents use to respond to their child's behaviors. Hyper and Hypo mean domain scores will be reported (range = 1-5). Greater domain scores indicate a greater presence of that type of sensory response.
Outcome measures
| Measure |
PC Followed by SR
n=21 Participants
Using the PIE intervention, parents will first be coached to respond to their infant's pre-linguistic communication cues. After posttest 1, they will be coached in responding to the infant's sensory reactivity cues.
|
SR Followed by PC
n=15 Participants
Using the PIE intervention, parents will first be coached to respond to their infant's sensory reactivity cues. After posttest 1, they will be coached in responding to the infant's pre-linguistic communication cues.
|
|---|---|---|
|
Change in The Sensory Experiences Questionnaire Version 2.1 From Baseline to Posttest 2 in Hypo-reactivity
Baseline
|
2.18 score on a scale
Standard Deviation 0.62
|
1.92 score on a scale
Standard Deviation 0.69
|
|
Change in The Sensory Experiences Questionnaire Version 2.1 From Baseline to Posttest 2 in Hypo-reactivity
Posttest 2
|
2.31 score on a scale
Standard Deviation 0.85
|
2.27 score on a scale
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: Baseline, Posttest 2 (13-16 weeks after baseline)Population: Data are unavailable for 3 enrolled children at Baseline and 16 at Posttest 2.
A 43 item parent questionnaire that asks about the child's responses to various sensory stimuli in the context of functional activities and daily routines in the child's environment. It also documents strategies parents use to respond to their child's behaviors. Hyper and Hypo mean domain scores will be reported (range = 1-5). Greater domain scores indicate a greater presence of that type of sensory response.
Outcome measures
| Measure |
PC Followed by SR
n=21 Participants
Using the PIE intervention, parents will first be coached to respond to their infant's pre-linguistic communication cues. After posttest 1, they will be coached in responding to the infant's sensory reactivity cues.
|
SR Followed by PC
n=15 Participants
Using the PIE intervention, parents will first be coached to respond to their infant's sensory reactivity cues. After posttest 1, they will be coached in responding to the infant's pre-linguistic communication cues.
|
|---|---|---|
|
Change in The Sensory Experiences Questionnaire Version 2.1 From Baseline to Posttest 2 in Hyper-reactivity
Baseline
|
2.03 score on a scale
Standard Deviation 0.34
|
1.81 score on a scale
Standard Deviation 0.33
|
|
Change in The Sensory Experiences Questionnaire Version 2.1 From Baseline to Posttest 2 in Hyper-reactivity
Posttest 2
|
1.92 score on a scale
Standard Deviation 0.22
|
2.21 score on a scale
Standard Deviation 0.59
|
Adverse Events
PC Followed by SR
SR Followed by PC
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Linda R. Watson, EdD
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place