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Evaluation of a Novel Intervention for Infants At Risk for Neurodevelopmental Disorders (PIE)

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ClinicalTrials.gov Identifier: NCT03388294
Recruitment Status : Recruiting
First Posted : January 2, 2018
Last Update Posted : March 15, 2018
Sponsor:
Collaborators:
University of Southern California
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief 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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Neurodevelopmental Disorders Behavioral: Parents and Infants Engaged Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: The intervention phases of the study will use a randomized comparative trial design, with two phases. For Study Phase 1, dyads will participate in pretesting; then families will be randomized, stratifying by child age, to one of two treatment arms. Arm 1 families will participate in initial coaching on the PIE sensory reactivity (SR) domain, and Arm 2 families will participate in initial coaching on the PIE prelinguistic communication (PC) domain. Families will participate in 6 weekly coaching sessions in their respective treatment arms, and return for Posttest-1. For Study Phase 2, dyads in Arm 1 will receive 6 weekly coaching sessions on the PC domain, and dyads in Arm 2 will receive 6 weekly coaching sessions on the SR domain. Then families will return for Posttest-2. Follow-up assessments are planned at 3 months after Posttest-2, and at ages 30 and 36 months, to track diagnostic and developmental outcomes of this at-risk sample.
Masking: Single (Outcomes Assessor)
Masking Description: Assessors at all time points after randomization will be blind to the child's treatment arm allocation. Since parents are being coached as part of the intervention, it is not possible to keep them blind to their treatment arm.
Primary Purpose: Treatment
Official Title: Evaluation of a Novel Intervention for Infants At Risk for Neurodevelopmental Disorders
Actual Study Start Date : March 8, 2018
Estimated Primary Completion Date : August 15, 2019
Estimated Study Completion Date : July 15, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PC followed by SR
Parents will be coached for 6 weekly sessions in the Parents and Infants Engaged (PIE) intervention pre-linguistic (PC) domain to identify their child's pre-linguistic communication bids during daily routines and respond to those bids in ways that optimize parent-child engagement. After posttest 1, they will be coached for 6 weekly sessions on sensory reactivity bids.
Behavioral: Parents and Infants Engaged
A novel in-home parent coaching intervention addressing transactions between pre-linguistic communication and sensory reactivity in infants at-risk for autism and other NDs on the one hand, and parent responses to infant cues on the other hand, using live coaching and video feedback methods.
Other Name: PIE

Experimental: SR followed by PC
Parents will be coached for 6 weekly sessions in the Parents and Infants Engaged (PIE) intervention sensory reactions (SR) domain to identify their child's sensory reactions to daily activities and respond to those reactions or modify the environment in ways that optimize parent-child engagement. After posttest 1, they will be coached for 6 weekly sessions on pre-linguistic communication bids.
Behavioral: Parents and Infants Engaged
A novel in-home parent coaching intervention addressing transactions between pre-linguistic communication and sensory reactivity in infants at-risk for autism and other NDs on the one hand, and parent responses to infant cues on the other hand, using live coaching and video feedback methods.
Other Name: PIE




Primary Outcome Measures :
  1. Change in Parent Child Engagement Coding from pretest to posttest 1 [ Time Frame: Baseline, posttest 1 (6-8 weeks after pretest) ]
    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 joint engagement (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.

  2. Change in Parent Child Engagement Coding from pretest to posttest 2 [ Time Frame: Baseline, posttest 2 (13-16 weeks after pretest) ]
    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 joint engagement (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.


Secondary Outcome Measures :
  1. Change in Mullen Scales of Early Learning Receptive Language T-Scores from pretest to posttest 2 [ Time Frame: Baseline, posttest 2 (13-16 weeks after pretest) ]
    The MSEL is a standardized developmental assessment for children birth to 58 months, frequently used in studies of children with NDs, and comprised of 4 scales: Fine Motor, Visual Reception, Receptive Language, and Expressive Language. The investigators will administer only the Receptive and Expressive Language subscales of the MSEL at the second posttest and the first follow up assessment. To be eligible for the intervention portion of the study, children have to score at least 1 s.d. below the mean on either the Receptive or Expressive Language subscale of the MSEL. The investigators will report t scores (Mean = 50, SD = 10)and the standardized total Early Learning Composite (Mean = 100, SD = 15). Higher scores indicate greater developmental skills.

  2. Change in Mullen Scales of Early Learning Expressive Language T-scores from pretest to posttest 2 [ Time Frame: Baseline, posttest 2 (13-16 weeks after pretest) ]
    The MSEL is a standardized developmental assessment for children birth to 58 months, frequently used in studies of children with NDs, and comprised of 4 scales: Fine Motor, Visual Reception, Receptive Language, and Expressive Language. The investigators will administer only the Receptive and Expressive Language subscales of the MSEL at the second posttest and the first follow up assessment. To be eligible for the intervention portion of the study, children have to score at least 1 s.d. below the mean on either the Receptive or Expressive Language subscale of the MSEL. The investigators will report t scores (Mean = 50, SD = 10)and the standardized total Early Learning Composite (Mean = 100, SD = 15). Higher scores indicate greater developmental skills.

  3. Change in Sensory Processing Assessment for Young Children from Pretest to Posttest 2 [ Time Frame: Baseline, posttest 2 (13-16 weeks after pretest) ]
    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), 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).

  4. Change in The Behavioral Observation of Social Communication Change (BOSCC) from pretest to posttest 2 [ Time Frame: Baseline, posttest 2 (13-16 weeks after pretest) ]
    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 typical social communication skills, lower scores indicate poorer skills.

  5. Change in The Attention Following Protocol (AF Protocol) from pretest to posttest 2 [ Time Frame: Baseline, posttest 2 (13-16 weeks after pretest) ]
    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.

  6. Baseline expressive communication level: The MacArthur-Bates Communicative Development Inventory [ Time Frame: Baseline ]
    A parent report measure of children's expressive communication skills, such as vocabulary and pre-grammar abilities. The Words and Gestures (toddler) form will be used. Total words and gestures endorsed by parents will be reported. Greater words and gestures reported indicates larger expressive vocabulary.

  7. Change in The Sensory Experiences Questionnaire version 2.1 from pretest to posttest 1 [ Time Frame: Baseline, posttest 1 (6-8 weeks after pretest) ]
    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.

  8. Change in The Sensory Experiences Questionnaire version 2.1 from pretest to posttest 2 [ Time Frame: Baseline, posttest 2 (13-16 weeks after pretest) ]
    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.

  9. Baseline level of parent stress: Parental Stress Scale [ Time Frame: Baseline ]
    The Parental Stress Scale is a brief, 18-item scale designed to assess parent stress in nonclinical or clinical populations. It has acceptable levels of internal consistency (coefficient α = .83) and test-retest reliability (r = .81 over 6 weeks). It has good concurrent validity with the widely used Parent StressIndex (r =.75), which is a longer, more intrusive measure. A total score will be reported (range = 18-90).

  10. Change in Respiratory sinus arrhythmia from pretest to posttest 1 [ Time Frame: Baseline, posttest 1 (6-8 weeks after pretest) ]
    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.

  11. Change in Respiratory sinus arrhythmia from pretest to posttest 2 [ Time Frame: Baseline, posttest 2 (13-16 weeks after pretest) ]
    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.

  12. Change in skin conductance levels from pretest to posttest 1 [ Time Frame: Baseline, posttest 1 (6-8 weeks after pretest) ]
    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.

  13. Change in skin conductance levels from pretest to posttest 2 [ Time Frame: Baseline, posttest 2 (13-16 weeks after pretest) ]
    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.

  14. Change in Parent Responsiveness to Child Prelinguistic Communication Cues from pretest to posttest 1 [ Time Frame: Baseline, posttest 1 (6-8 weeks after pretest) ]
    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.

  15. Change in Parent Responsiveness to Child Prelinguistic Communication Cues from pretest to posttest 2 [ Time Frame: Baseline, posttest 2 (13-16 weeks after pretest) ]
    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.

  16. Change in Parent Responsiveness to Child Sensory Reactivity Cues from pretest to posttest 1 [ Time Frame: Baseline, posttest 1 (6-8 weeks after pretest) ]
    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.

  17. Change in Parent Responsiveness to Child Sensory Reactivity Cues from pretest to posttest 2 [ Time Frame: Baseline, posttest 2 (13-16 weeks after pretest) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Months to 16 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 at-risk while misclassifying less than 5% of the TD sample as a-risk) AND 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 HYPO or 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)
  • Inclusion criteria for the low risk control group will be scoring below the 95th percentile on the FYI between 11 and 16 months. Inclusion criteria for the high risk but ineligible for intervention control group will be scoring at or above the at-risk score on the FYI but not meeting criteria on the SPA and/or MSEL during their behavioral assessment.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03388294


Contacts
Contact: Sallie W Nowell, MS 919-843-5498 nowell@unc.edu
Contact: Linda R Watson, EdD (919) 966-9466 linda_watson@med.unc.edu

Locations
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27607
Contact: Study Coordinator    919-843-5498    PIEstudy@unc.edu   
Contact: Linda R Watson, EdD    9199669466    lwatson@med.unc.edu   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
University of Southern California
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Grace T Baranek, PhD University of Southern California
Principal Investigator: Linda R Watson, EdD University of North Carolina, Chapel Hill

Publications:
Tamis-LeMonda CS, Kuchirko Y, Song L. Why is infant language learning facilitated by parental responsiveness? Current Directions in Psychological Science. 2014;23(2):121-126.
Ben-Sasson A, Carter AS. The contribution of sensory-regulatory markers to the accuracy of ASD screening at 12 months. Research in Autism Spectrum Disorders. 2013;7(7):879-888.
Baranek GT, Watson LR, Crais E, Reznick S. First-year inventory (FYI) 2.0. University of North Carolina at Chapel Hill; 2003.
Watson LR, Roberts JE, Baranek GT, Yoder P. Respiratory sinus arrhythmia as a predictor of language outcomes in children with autism. International Journal of Psychophysiology. 2012;85(3):348. Accessed 9/28/2015 2:41:37 PM.

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03388294     History of Changes
Other Study ID Numbers: 17-0292
1R21HD091547-01 ( U.S. NIH Grant/Contract )
First Posted: January 2, 2018    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of North Carolina, Chapel Hill:
communication
sensory
early intervention
parent coaching

Additional relevant MeSH terms:
Disease
Autism Spectrum Disorder
Neurodevelopmental Disorders
Pathologic Processes
Child Development Disorders, Pervasive
Mental Disorders