N/A N=72 Randomized Single-blind Treatment

Evaluation of a Novel Intervention for Infants At Risk for Neurodevelopmental Disorders

Autism Spectrum Disorder · Neurodevelopmental Disorders

Bottom Line

View on ClinicalTrials.gov: NCT03388294 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2021

Primary outcome: Primary: Change in Mean Percent of Parent Child Dyadic Engagement Over Time From Baseline to Posttest 1 — 22.01; 16.91; 26.55; 27.09 percent time in dyadic engagement — p=0.028

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Parents and Infants Engaged (Behavioral)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: University of North Carolina, Chapel Hill
Primary completion: Apr 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Mean Percent of Parent Child Dyadic Engagement Over Time From Baseline to Posttest 1	22.01; 16.91; 26.55; 27.09	0.028 sig
PRIMARY Change in Mean Percent of Parent Child Dyadic Engagement Over Time From Baseline to Posttest 2	22.01; 16.91; 30.12; 35.23	<0.001 sig
SECONDARY Change in Rating of Parent Responsiveness to Child Sensory Reactivity Cues From Baseline to Posttest 1	3.73; 3.47; 4.33; 4.02	0.87
SECONDARY Change in Rating of Parent Responsiveness to Child Sensory Reactivity Cues From Baseline to Posttest 2	3.73; 3.47; 4.03; 4.39	0.006 sig
SECONDARY Change in Rating of Parent Responsiveness to Child Prelinguistic Communication Cues From Baseline to Posttest 1	4.04; 4.57; 4.54; 4.88	0.76
SECONDARY Change in Rating of Parent Responsiveness to Child Prelinguistic Communication Cues From Baseline to Posttest 2	4.04; 4.57; 4.39; 4.32	0.849
SECONDARY Change in Rate of Infant Intentional Communication Over Time, Baseline to Posttest 1	0.48; 0.48; 0.71; 0.67	0.063
SECONDARY Change in Rate of Infant Intentional Communication Over Time, Baseline to Posttest 2	0.48; 0.48; 0.92; 1.03	<0.001 sig
SECONDARY Change in Respiratory Sinus Arrhythmia From Baseline to Posttest 2 During Social Stimuli	4.07; 4.54; 4.52; 4.25	—
SECONDARY Change in Respiratory Sinus Arrhythmia From Baseline to Posttest 2 During Non-Social Stimuli	3.81; 4.24; 4.36; 3.61	—
SECONDARY Change in Skin Conductance Levels From Baseline to Posttest 2	—	—
SECONDARY Change in The Behavioral Observation of Social Communication Change (BOSCC) From Baseline to Posttest 2	34.06; 30.96; 29.40; 29.62	0.036 sig
SECONDARY Change in The Attention Following Protocol (AF Protocol) From Baseline to Posttest 2	2.14; 2.93; 3.78; 4.00	0.0002 sig
SECONDARY Change in Mullen Scales of Early Learning Receptive Language T-Scores From Baseline to Posttest 2	30.19; 34.33; 30.56; 33.71	0.864
SECONDARY Change in Mullen Scales of Early Learning Expressive Language T-scores From Baseline to Posttest 2	32.38; 32.93; 34.06; 37.29	0.12
SECONDARY Change in Sensory Processing Assessment for Young Children From Baseline to Posttest 2 in Hypo-Reactivity	2.58; 2.10; 2.61; 1.99	0.881
SECONDARY Change in Sensory Processing Assessment for Young Children From Baseline to Posttest 2 in Hyper-Reactivity	1.66; 1.55; 1.59; 1.59	0.846
SECONDARY Change in The Sensory Experiences Questionnaire Version 2.1 From Baseline to Posttest 1 in Hypo-reactivity	2.18; 1.92; 2.26; 2.04	—
SECONDARY Change in The Sensory Experiences Questionnaire Version 2.1 From Baseline to Posttest 1 in Hyper-reactivity	2.03; 1.81; 1.92; 1.85	—
SECONDARY Change in The Sensory Experiences Questionnaire Version 2.1 From Baseline to Posttest 2 in Hypo-reactivity	2.18; 1.92; 2.31; 2.27	—
SECONDARY Change in The Sensory Experiences Questionnaire Version 2.1 From Baseline to Posttest 2 in Hyper-reactivity	2.03; 1.81; 1.92; 2.21	—

Summary

This study entails a "proof of concept" evaluation of a novel intervention, Parents and Infants Engaged (PIE), for prodromal infants at-risk for neurodevelopmental disorders (NDs). The objectives of the current study are to examine whether the PIE intervention (a) transforms parent-infant transactions over time as intended, thereby facilitating increases in the time infants spend in joint engagement with their parents, and (b) is associated with improved social-communication functioning and positive changes in indices of autonomic self-regulation in infants at-risk for NDs.

Eligibility Criteria

Inclusion Criteria

For the intervention trial: infant must meet risk criteria on the First Years Inventory (Calculated based on data collected in another study where risk status on the FYI was confirmed with follow up at 3 years. We empirically determined combinations of the two FYI domain scores that would sort respondents into "at-risk" and "not-at-risk." The resulting cut-points enabled us to sort children such that we capture about 1/3 of those who would go on to be confirmed as having a autism spectrum diagnosis while misclassifying less than 5% of the typically developing (TD) sample as at-risk). Infants also must score at least one s.d. below the mean on either the Receptive or Expressive subscale t scores AND meet the following SPA inclusion criteria on hyporeactivity (HYPO) or hyperreactivity (HYPER):
"HYPO": Cut-point (equal or greater than) of 1.69 for Mean of the raw orienting score across 7 items, each with the range of 1 to 4 possible points)
"HYPER": Cut-point (equal or greater than) of .333 for Mean of the raw approach/avoid novel toys score across 9 items, each with the range of 0 to 2 possible points) OR Any clear "defensive" response on orienting items or "Yes" to covering ears to sound (in stereotypies checklist)

Exclusion Criteria

families who speak English < 50% of the time at home
infants with previously identified genetic disorders (e.g., Down syndrome)
infants with identified vision/hearing/physical impairments.

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Data sourced from ClinicalTrials.gov (NCT03388294). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.