Recruiting

Responsive Parenting

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT04856501

Conditions

Premature Birth

Eligibility Criteria

Sex: All

Age: 1 - 2

Healthy Volunteers: Not accepted

Interventions

PALS intervention condition

Control condition

Study Details

Brief summary:

The purpose of this study is to determine whether participation in the Play and Learning Strategies (PALS) parenting intervention results in increased caregiver responsiveness behaviors and to test if participation in PALS results in increases in toddler skills and/or toddler neurological development.

Conditions

Premature Birth

Study ID

NCT04856501

Start date

Aug 7, 2020

Status verified date

Mar, 2025

Completion date

Jun 30, 2025

Anticipated

Primary completion date

Jun 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 2

Healthy Volunteers: Not accepted

Inclusion Criteria:

- Maternal age over 18-years when child was born

Exclusion Criteria:

  • presence of known/suspected congenital anomalies including chromosomal or complex congenital heart disease
  • congenital infection including TORCH (Toxoplasmosis, Rubella, Cytomegalovirus, Herpes Simplex and others),untreated maternal HIV, or maternal syphilis
  • bilateral grade 3/4 intraventricular hemorrhage,intraparenchymal hemorrhage, hydrocephalus
  • Cerebral palsy with Gross Motor Function Classification of III or higher
  • blindness-
  • deafness
  • Current maternal drug use or maternal drug use during pregnancy
  • families who reside outside the catchment area (>1 hour drive from the Texas Medical Center)
  • Child with contraindication for MRI. If the mother of the child is pregnant, thinks she might be pregnant, or has a contraindication for MRI, another relative of the child will be asked to assist with the MRIs

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: PALS intervention condition

active comparator: Control condition

Interventions

PALS intervention condition

The Play and Learning Strategies (PALS) intervention provides parents with behaviors that, collectively, are known as a responsive parenting style. Four constructs make up this responsive parenting style: 1) contingent responsiveness, (responses are conditionally linked to the child's signals) 2) warm sensitivity (high levels of affection and understanding of child states), 3) maintaining vs. redirecting attention, and 4) verbal scaffolding (providing child appropriate language supports). Parents assigned to this intervention will be paired with a coach who will guide them through the program over the course of 9 weekly sessions. The intervention (ePALS) will be implemented via an internet adaptation through the Children's Learning Institute's ENGAGE platform. However, ePALS could easily be adapted for other platforms and accessed with any web-enabled device.

Control condition

Families assigned to the control condition will be provided with a website with information corresponding to milestones of toddler development. Control families will be asked to review that week's materials before the each of the 9 weekly coach calls. The active control condition serves three important purposes: 1) Maintains an active line of communication and accurate contact records for Post-test 1 and Post-test 2 session scheduling; 2) Masks participant's awareness of intervention vs. control assignment; and 3) Approximates communication with intervention staff such that results showing ePALS effects are attributable to intervention rather than regular communication with an interventionist.

Primary outcome measure

  • Change in Parental contingent responsiveness as measured by the Parent-child Toy Play Observation [ Time Frame: Baseline, Post-test 1 (1-2 weeks after intervention) ]
  • Change in Parental warm sensitivity (display of positive affect) as measured by the Parent-child Toy Play Observation [ Time Frame: Baseline, Post-test 1 (1-2 weeks after intervention) ]
  • Change in Parental warm sensitivity (warmth) as measured by the Parent-child Toy Play Observation [ Time Frame: Baseline, Post-test 1 (1-2 weeks after intervention) ]
  • Change in Parental maintaining of child's signals and interests as measured by the Parent-child Toy Play Observation [ Time Frame: Baseline, Post-test 1 (1-2 weeks after intervention) ]
  • Change in Parental verbal scaffolding as measured by the Parent-child Toy Play Observation [ Time Frame: Baseline, Post-test 1 (1-2 weeks after intervention) ]
  • Change in Child attentional engagement (engagement with environment) as measured by the Parent-child Toy Play Observation [ Time Frame: Baseline, Post-test 1 (1-2 weeks after intervention) ]
  • Change in Child attentional engagement (social engagement) as measured by the Parent-child Toy Play Observation [ Time Frame: Baseline, Post-test 1 (1-2 weeks after intervention) ]
  • Change in Child emotional regulation as measured by the Parent-child Toy Play Observation [ Time Frame: Baseline, Post-test 1 (1-2 weeks after intervention) ]
  • Change in Child cooperation as measured by the Parent-child Toy Play Observation [ Time Frame: Baseline, Post-test 1 (1-2 weeks after intervention) ]
  • Change in Child emotional regulation (proximity seeking behaviors) as assessed by score on Waiting Task [ Time Frame: Baseline, Post-test 1 (1-2 weeks after intervention) ]
  • Change in Child emotional regulation (venting/aggression/distress behaviors) as assessed by score on Waiting Task [ Time Frame: Baseline, Post-test 1 (1-2 weeks after intervention) ]
  • Change in Child emotional regulation (disengaged behavior) as assessed by score on Waiting Task [ Time Frame: Baseline, Post-test 1 (1-2 weeks after intervention) ]
  • Change in Child inhibition (verbal distraction) as assessed by score on Waiting Task [ Time Frame: Baseline, Post-test 1 (1-2 weeks after intervention) ]
  • Change in Child inhibition (self-distraction) as assessed by score on Waiting Task [ Time Frame: Baseline, Post-test 1 (1-2 weeks after intervention) ]
  • Change in number of times parent exhibit warm sensitivity (physical soothing behaviors) as measured by the Waiting Task [ Time Frame: Baseline, Post-test 1 (1-2 weeks after intervention) ]
  • Change in number of times parent exhibits parental verbal scaffolding (verbal distraction behaviors) as measured by the Waiting Task [ Time Frame: Baseline, Post-test 1 (1-2 weeks after intervention) ]
  • Change in number of times parent exhibits parental contingent responsiveness (responsive behavior - promotion behaviors) as measured by the Waiting Task [ Time Frame: Baseline, Post-test 1 (1-2 weeks after intervention) ]
  • Change in Number of times parent exhibits non-responsive behavior(prevention behaviors) as measured by the Waiting Task [ Time Frame: Baseline, Post-test 1 (1-2 weeks after intervention) ]
  • Change in number of times parent exhibits parental non-responsive behavior(destructive coping and harsh physical restraint behaviors) as measured by the Waiting Task [ Time Frame: Baseline, Post-test 1 (1-2 weeks after intervention) ]
  • Change in Childs problem solving skill as measured by the Independent Toy Play task [ Time Frame: Baseline, Post-test-2 (4 months after post test1) ]
  • Change in Child working memory as assessed by the 3-6-9 box task [ Time Frame: Baseline, Post-test-2 (4 months after post test1) ]
  • Change in Child's self-restraint as assessed by score on the Gift Wrap step of the Gift Wrap/Waiting for Bow task [ Time Frame: Baseline, Post-test-2 (4 months after post test1) ]
  • Change in Child's self-restraint as assessed by score on the Waiting for Bow step of the Gift Wrap/Waiting for Bow task [ Time Frame: Baseline, Post-test-2 (4 months after post test1) ]
  • Change in Child's distraction as assessed by score in the Waiting for Bow step of the Gift Wrap/Waiting for Bow task [ Time Frame: Baseline, Post-test-2 (4 months after post test1) ]
  • Change in Noncompliance behaviors of child toward parent as measured by the Tool task [ Time Frame: Baseline, Post-test-2 (4 months after post test1) ]
  • Change in anger behaviors of child as measured by the Tool task [ Time Frame: Baseline, Post-test-2 (4 months after post test1) ]
  • Change in anger/frustration behaviors specifically directed to parent as measured by the Tool task [ Time Frame: Baseline, Post-test-2 (4 months after post test1) ]
  • Change in child coping as measured by the Tool task [ Time Frame: Baseline, Post-test-2 (4 months after post test1) ]
  • Change in Child enthusiasm for the task as measured by the Tool task [ Time Frame: Baseline, Post-test-2 (4 months after post test1) ]
  • Change in Child persistence behaviors related to attention as measured by the Tool task [ Time Frame: Baseline, Post-test-2 (4 months after post test1) ]
  • Change in children's developing abilities in early language as assessed by the MacArthur-Bates Communicative Development Inventories (MB-CDIs) [ Time Frame: Baseline, Post-test 2 (4 months after post test1) ]
  • Change in Attention Disengagement to Positive and Negative Emotions as assessed by total time child looked at faces on screen during the looking task [ Time Frame: Baseline, Post-test 2 (4 months after post test1) ]
  • Change in Attention Disengagement to Positive and Negative Emotions as assessed by longest individual time child looked at faces on screen during the looking task [ Time Frame: Baseline, Post-test 2 (4 months after post test1) ]
  • Change in Attention Disengagement to Positive and Negative Emotions as assessed by the number of times child looked away from the faces and toward the distractor during the looking task [ Time Frame: Baseline, Post-test 2 (4 months after post test1) ]
  • Change in White matter structural integrity as indicated by fractional anisotropy measured by diffusion tensor imaging (DTI) magnetic resonance imaging (MRI) - uncinate fasciculus tract [ Time Frame: Baseline, Post-test 2 (4 months after post test1) ]
  • Change in White matter structural integrity as indicated by fractional anisotropy measured by diffusion tensor imaging (DTI) magnetic resonance imaging (MRI) - anterior thalamic radiation tract [ Time Frame: Baseline, Post-test 2 (4 months after post test1) ]
  • Change in White matter structural integrity as indicated by fractional anisotropy measured by diffusion tensor imaging (DTI) magnetic resonance imaging (MRI) - cingulum tract [ Time Frame: Baseline, Post-test 2 (4 months after post test1) ]
  • Change in White matter structural integrity as indicated by fractional anisotropy measured by diffusion tensor imaging (DTI) magnetic resonance imaging (MRI) - fornix tract [ Time Frame: Baseline, Post-test 2 (4 months after post test1) ]
  • Change in functional activity during rest as indicated by Resting Electroencephalography (EEG) value [ Time Frame: Baseline, Post-test 2 (4 months after post test1) ]
  • Change in functional activity when engaged in sustained activity as indicated by Event-related potential (ERP) negative central (NC) value recorded during EEG [ Time Frame: Baseline, Post-test 2 (4 months after post test1) ]
  • Change in functional activity when engaged in sustained activity as indicated by Event-related potential (ERP) positive slow wave (PSW) value recorded during EEG [ Time Frame: Baseline, Post-test 2 (4 months after post test1) ]

Central Contacts and Locations

Central contacts

Dana DeMaster, PhD

(713) 500-8315Dana.M.DeMaster@uth.tmc.edu

Kelly Vaughn

713-500-8243Kelly.A.Vaughn@uth.tmc.edu

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Dana DeMaster, PhD

(713) 500-8315Dana.M.DeMaster@uth.tmc.edu

Kelly Vaughn

713-500-8243Kelly.A.Vaughn@uth.tmc.edu

Principal Investigator:

Susan Landry

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Mar 28, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2025-03-28.