Clinical trial NCT04856501: A Randomized Control Trial of a Responsive Parenting Intervention to Support Healthy Brain Development and Self-regulation in Toddlers Born Preterm
Official title: A Randomized Control Trial of a Responsive Parenting Intervention to Support Healthy Brain Development and Self-regulation in Toddlers Born Preterm
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Premature Birth
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Herman H. Fleishman Foundation
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-04-23
Enrollment: 300
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Parental contingent responsiveness as measured by the Parent-child Toy Play Observation
timeFrame: Baseline, Post-test 1 (1-2 weeks after intervention)
measure: Change in Parental warm sensitivity (display of positive affect) as measured by the Parent-child Toy Play Observation
timeFrame: Baseline, Post-test 1 (1-2 weeks after intervention)
measure: Change in Parental warm sensitivity (warmth) as measured by the Parent-child Toy Play Observation
timeFrame: Baseline, Post-test 1 (1-2 weeks after intervention)
measure: Change in Parental maintaining of child's signals and interests as measured by the Parent-child Toy Play Observation
timeFrame: Baseline, Post-test 1 (1-2 weeks after intervention)
measure: Change in Parental verbal scaffolding as measured by the Parent-child Toy Play Observation
timeFrame: Baseline, Post-test 1 (1-2 weeks after intervention)
measure: Change in Child attentional engagement (engagement with environment) as measured by the Parent-child Toy Play Observation
timeFrame: Baseline, Post-test 1 (1-2 weeks after intervention)
measure: Change in Child attentional engagement (social engagement) as measured by the Parent-child Toy Play Observation
timeFrame: Baseline, Post-test 1 (1-2 weeks after intervention)
measure: Change in Child emotional regulation as measured by the Parent-child Toy Play Observation
timeFrame: Baseline, Post-test 1 (1-2 weeks after intervention)
measure: Change in Child cooperation as measured by the Parent-child Toy Play Observation
timeFrame: Baseline, Post-test 1 (1-2 weeks after intervention)
measure: Change in Child emotional regulation (proximity seeking behaviors) as assessed by score on Waiting Task
timeFrame: Baseline, Post-test 1 (1-2 weeks after intervention)
measure: Change in Child emotional regulation (venting/aggression/distress behaviors) as assessed by score on Waiting Task
timeFrame: Baseline, Post-test 1 (1-2 weeks after intervention)
measure: Change in Child emotional regulation (disengaged behavior) as assessed by score on Waiting Task
timeFrame: Baseline, Post-test 1 (1-2 weeks after intervention)
measure: Change in Child inhibition (verbal distraction) as assessed by score on Waiting Task
timeFrame: Baseline, Post-test 1 (1-2 weeks after intervention)
measure: Change in Child inhibition (self-distraction) as assessed by score on Waiting Task
timeFrame: Baseline, Post-test 1 (1-2 weeks after intervention)
measure: Change in number of times parent exhibit warm sensitivity (physical soothing behaviors) as measured by the Waiting Task
timeFrame: Baseline, Post-test 1 (1-2 weeks after intervention)
measure: Change in number of times parent exhibits parental verbal scaffolding (verbal distraction behaviors) as measured by the Waiting Task
timeFrame: Baseline, Post-test 1 (1-2 weeks after intervention)
measure: Change in number of times parent exhibits parental contingent responsiveness (responsive behavior - promotion behaviors) as measured by the Waiting Task
timeFrame: Baseline, Post-test 1 (1-2 weeks after intervention)
measure: Change in Number of times parent exhibits non-responsive behavior(prevention behaviors) as measured by the Waiting Task
timeFrame: Baseline, Post-test 1 (1-2 weeks after intervention)
measure: Change in number of times parent exhibits parental non-responsive behavior(destructive coping and harsh physical restraint behaviors) as measured by the Waiting Task
timeFrame: Baseline, Post-test 1 (1-2 weeks after intervention)
measure: Change in Childs problem solving skill as measured by the Independent Toy Play task
timeFrame: Baseline, Post-test-2 (4 months after post test1)
measure: Change in Child working memory as assessed by the 3-6-9 box task
timeFrame: Baseline, Post-test-2 (4 months after post test1)
measure: Change in Child's self-restraint as assessed by score on the Gift Wrap step of the Gift Wrap/Waiting for Bow task
timeFrame: Baseline, Post-test-2 (4 months after post test1)
measure: Change in Child's self-restraint as assessed by score on the Waiting for Bow step of the Gift Wrap/Waiting for Bow task
timeFrame: Baseline, Post-test-2 (4 months after post test1)
measure: Change in Child's distraction as assessed by score in the Waiting for Bow step of the Gift Wrap/Waiting for Bow task
timeFrame: Baseline, Post-test-2 (4 months after post test1)
measure: Change in Noncompliance behaviors of child toward parent as measured by the Tool task
timeFrame: Baseline, Post-test-2 (4 months after post test1)
measure: Change in anger behaviors of child as measured by the Tool task
timeFrame: Baseline, Post-test-2 (4 months after post test1)
measure: Change in anger/frustration behaviors specifically directed to parent as measured by the Tool task
timeFrame: Baseline, Post-test-2 (4 months after post test1)
measure: Change in child coping as measured by the Tool task
timeFrame: Baseline, Post-test-2 (4 months after post test1)
measure: Change in Child enthusiasm for the task as measured by the Tool task
timeFrame: Baseline, Post-test-2 (4 months after post test1)
measure: Change in Child persistence behaviors related to attention as measured by the Tool task
timeFrame: Baseline, Post-test-2 (4 months after post test1)
measure: Change in children's developing abilities in early language as assessed by the MacArthur-Bates Communicative Development Inventories (MB-CDIs)
timeFrame: Baseline, Post-test 2 (4 months after post test1)
measure: Change in Attention Disengagement to Positive and Negative Emotions as assessed by total time child looked at faces on screen during the looking task
timeFrame: Baseline, Post-test 2 (4 months after post test1)
measure: 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
timeFrame: Baseline, Post-test 2 (4 months after post test1)
measure: 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
timeFrame: Baseline, Post-test 2 (4 months after post test1)
measure: Change in White matter structural integrity as indicated by fractional anisotropy measured by diffusion tensor imaging (DTI) magnetic resonance imaging (MRI) - uncinate fasciculus tract
timeFrame: Baseline, Post-test 2 (4 months after post test1)
measure: 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
timeFrame: Baseline, Post-test 2 (4 months after post test1)
measure: Change in White matter structural integrity as indicated by fractional anisotropy measured by diffusion tensor imaging (DTI) magnetic resonance imaging (MRI) - cingulum tract
timeFrame: Baseline, Post-test 2 (4 months after post test1)
measure: Change in White matter structural integrity as indicated by fractional anisotropy measured by diffusion tensor imaging (DTI) magnetic resonance imaging (MRI) - fornix tract
timeFrame: Baseline, Post-test 2 (4 months after post test1)
measure: Change in functional activity during rest as indicated by Resting Electroencephalography (EEG) value
timeFrame: Baseline, Post-test 2 (4 months after post test1)
measure: Change in functional activity when engaged in sustained activity as indicated by Event-related potential (ERP) negative central (NC) value recorded during EEG
timeFrame: Baseline, Post-test 2 (4 months after post test1)
measure: Change in functional activity when engaged in sustained activity as indicated by Event-related potential (ERP) positive slow wave (PSW) value recorded during EEG
timeFrame: Baseline, Post-test 2 (4 months after post test1)
Secondary outcomes:
measure: Maternal depression as measured by the Beck's Depression Inventory
timeFrame: Post-test 1 (1-2 weeks post intervention)
measure: Degree of chaos in the home as measured by the CHAOS questionnaire
timeFrame: Post-test 1 (1-2 weeks post intervention)
measure: COVID-19 Exposure and Family Impact as assessed by the COVID-19 Exposure and Family Impact Survey - Exposure Score
timeFrame: Post-test 1 (1-2 weeks post intervention)
measure: COVID-19 Exposure and Family Impact as assessed by the COVID-19 Exposure and Family Impact Survey - Impact Score
timeFrame: Post-test 1 (1-2 weeks post intervention)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Dana DeMaster, PhD
role: PRINCIPAL_INVESTIGATOR
References: