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

NCT03388294 | Completed Results

• 2 other identifiers: 17-02921R21HD091547-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder; Neurodevelopmental Disorders

Keywords

communication; sensory; early intervention; parent coaching

Outcome Measures

Primary Outcomes (2)

• Change in Mean Percent of Parent Child Dyadic Engagement Over Time From Baseline to 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.

  Baseline, Posttest 1 (6-8 weeks after baseline)

• Change in Mean Percent of Parent Child Dyadic Engagement Over Time From Baseline to 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.

  Baseline, Posttest 2 (13-16 weeks after baseline)

Secondary Outcomes (19)

• Change in Rating of Parent Responsiveness to Child Sensory Reactivity Cues From Baseline to Posttest 1

  Baseline, Posttest 1 (6-8 weeks after baseline)

• Change in Rating of Parent Responsiveness to Child Sensory Reactivity Cues From Baseline to Posttest 2

  Baseline, posttest 2 (13-16 weeks after baseline)

• Change in Rating of Parent Responsiveness to Child Prelinguistic Communication Cues From Baseline to Posttest 1

  Baseline, Posttest 1 (6-8 weeks after pretest)

• Change in Rating of Parent Responsiveness to Child Prelinguistic Communication Cues From Baseline to Posttest 2

  Baseline, Posttest 2 (13-16 weeks after baseline)

• Change in Rate of Infant Intentional Communication Over Time, Baseline to Posttest 1

  Baseline, Posttest 1 (6-8 weeks after pretest)

Study Arms (2)

PC followed by SR

EXPERIMENTAL

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

SR followed by PC

EXPERIMENTAL

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

Interventions

Parents and Infants Engaged BEHAVIORAL

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.

Also known as: PIE

PC followed by SR; SR followed by PC

Eligibility Criteria

• Age: 11 Months - 16 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• "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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• University of Southern California: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27607, United States

Location

Related Publications (23)

• 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.

  BACKGROUND

• Baranek GT, Watson LR, Turner-Brown L, Field SH, Crais ER, Wakeford L, Little LM, Reznick JS. Preliminary efficacy of adapted responsive teaching for infants at risk of autism spectrum disorder in a community sample. Autism Res Treat. 2015;2015:386951. doi: 10.1155/2015/386951. Epub 2015 Jan 11.

  PMID: 25648749 BACKGROUND

• Watson LR, Baranek GT, Roberts JE, David FJ, Perryman TY. Behavioral and physiological responses to child-directed speech as predictors of communication outcomes in children with autism spectrum disorders. J Speech Lang Hear Res. 2010 Aug;53(4):1052-64. doi: 10.1044/1092-4388(2009/09-0096). Epub 2010 Jul 14.

  PMID: 20631229 BACKGROUND

• Turner-Brown LM, Baranek GT, Reznick JS, Watson LR, Crais ER. The First Year Inventory: a longitudinal follow-up of 12-month-old to 3-year-old children. Autism. 2013 Sep;17(5):527-40. doi: 10.1177/1362361312439633. Epub 2012 Jul 10.

  PMID: 22781058 BACKGROUND

• Guthrie W, Swineford LB, Nottke C, Wetherby AM. Early diagnosis of autism spectrum disorder: stability and change in clinical diagnosis and symptom presentation. J Child Psychol Psychiatry. 2013 May;54(5):582-90. doi: 10.1111/jcpp.12008.

  PMID: 23078094 BACKGROUND

• Barnett MA, Gustafsson H, Deng M, Mills-Koonce WR, Cox M. Bidirectional Associations Among Sensitive Parenting, Language Development, and Social Competence. Infant Child Dev. 2012 Jul;21(4):374-393. doi: 10.1002/icd.1750.

  PMID: 25126021 BACKGROUND

• Mahoney G, Perales F. Relationship-focused early intervention with children with pervasive developmental disorders and other disabilities: a comparative study. J Dev Behav Pediatr. 2005 Apr;26(2):77-85. doi: 10.1097/00004703-200504000-00002.

  PMID: 15827458 BACKGROUND

• Kochanska G, Forman DR, Aksan N, Dunbar SB. Pathways to conscience: early mother-child mutually responsive orientation and children's moral emotion, conduct, and cognition. J Child Psychol Psychiatry. 2005 Jan;46(1):19-34. doi: 10.1111/j.1469-7610.2004.00348.x.

  PMID: 15660641 BACKGROUND

• Sameroff AJ, Mackenzie MJ. Research strategies for capturing transactional models of development: the limits of the possible. Dev Psychopathol. 2003 Summer;15(3):613-40. doi: 10.1017/s0954579403000312.

  PMID: 14582934 BACKGROUND

• Baker JK, Fenning RM, Howland MA, Baucom BR, Moffitt J, Erath SA. Brief Report: A Pilot Study of Parent-Child Biobehavioral Synchrony in Autism Spectrum Disorder. J Autism Dev Disord. 2015 Dec;45(12):4140-6. doi: 10.1007/s10803-015-2528-0.

  PMID: 26183724 BACKGROUND

• Feldman R. Mutual influences between child emotion regulation and parent-child reciprocity support development across the first 10 years of life: Implications for developmental psychopathology. Dev Psychopathol. 2015 Nov;27(4 Pt 1):1007-23. doi: 10.1017/S0954579415000656.

  PMID: 26439059 BACKGROUND

• Hill-Soderlund AL, Mills-Koonce WR, Propper C, Calkins SD, Granger DA, Moore GA, Gariepy JL, Cox MJ. Parasympathetic and sympathetic responses to the strange situation in infants and mothers from avoidant and securely attached dyads. Dev Psychobiol. 2008 May;50(4):361-76. doi: 10.1002/dev.20302.

  PMID: 18393278 BACKGROUND

• Baranek GT. Autism during infancy: a retrospective video analysis of sensory-motor and social behaviors at 9-12 months of age. J Autism Dev Disord. 1999 Jun;29(3):213-24. doi: 10.1023/a:1023080005650.

  PMID: 10425584 BACKGROUND

• 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.

  BACKGROUND

• Watson LR, Crais ER, Baranek GT, Dykstra JR, Wilson KP. Communicative gesture use in infants with and without autism: a retrospective home video study. Am J Speech Lang Pathol. 2013 Feb;22(1):25-39. doi: 10.1044/1058-0360(2012/11-0145). Epub 2012 Jul 30.

  PMID: 22846878 BACKGROUND

• Beauchaine TP, Gatzke-Kopp L, Neuhaus E, Chipman J, Reid MJ, Webster-Stratton C. Sympathetic- and parasympathetic-linked cardiac function and prediction of externalizing behavior, emotion regulation, and prosocial behavior among preschoolers treated for ADHD. J Consult Clin Psychol. 2013 Jun;81(3):481-493. doi: 10.1037/a0032302. Epub 2013 Apr 1.

  PMID: 23544677 BACKGROUND

• Lam-Cassettari C, Wadnerkar-Kamble MB, James DM. Enhancing Parent-Child Communication and Parental Self-Esteem With a Video-Feedback Intervention: Outcomes With Prelingual Deaf and Hard-of-Hearing Children. J Deaf Stud Deaf Educ. 2015 Jul;20(3):266-74. doi: 10.1093/deafed/env008. Epub 2015 Mar 28.

  PMID: 25819293 BACKGROUND

• Hoivik MS, Lydersen S, Drugli MB, Onsoien R, Hansen MB, Nielsen TS. Video feedback compared to treatment as usual in families with parent-child interactions problems: a randomized controlled trial. Child Adolesc Psychiatry Ment Health. 2015 Feb 12;9:3. doi: 10.1186/s13034-015-0036-9. eCollection 2015.

  PMID: 25699090 BACKGROUND

• Beauchaine TP, Neuhaus E, Gatzke-Kopp LM, Reid MJ, Chipman J, Brekke A, Olliges A, Shoemaker S, Webster-Stratton C. Electrodermal responding predicts responses to, and may be altered by, preschool intervention for ADHD. J Consult Clin Psychol. 2015 Apr;83(2):293-303. doi: 10.1037/a0038405. Epub 2014 Dec 8.

  PMID: 25486374 BACKGROUND

• Baranek GT, Watson LR, Crais E, Reznick S. First-year inventory (FYI) 2.0. University of North Carolina at Chapel Hill; 2003.

  BACKGROUND

• Watson LR, Patten E, Baranek GT, Poe M, Boyd BA, Freuler A, Lorenzi J. Differential associations between sensory response patterns and language, social, and communication measures in children with autism or other developmental disabilities. J Speech Lang Hear Res. 2011 Dec;54(6):1562-76. doi: 10.1044/1092-4388(2011/10-0029). Epub 2011 Aug 23.

  PMID: 21862675 BACKGROUND

• 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.

  BACKGROUND

• Grzadzinski R, Carr T, Colombi C, McGuire K, Dufek S, Pickles A, Lord C. Measuring Changes in Social Communication Behaviors: Preliminary Development of the Brief Observation of Social Communication Change (BOSCC). J Autism Dev Disord. 2016 Jul;46(7):2464-79. doi: 10.1007/s10803-016-2782-9.

  PMID: 27062034 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Neurodevelopmental Disorders; Communication

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Mental Disorders; Behavior

Results Point of Contact

• Title: Linda R. Watson, EdD
• Organization: University of North Carolina at Chapel Hill

lwatson@med.unc.edu

919-966-1007

Study Officials

• Grace T Baranek, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

• Linda R Watson, EdD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: January 2, 2018
• Study Start: March 8, 2018
• Primary Completion: April 1, 2020
• Study Completion: May 30, 2021
• Last Updated: October 29, 2021
• Results First Posted: October 29, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)