A Randomized Control Trial of a Responsive Parenting Intervention to Support Healthy Brain Development and Self-regulation in Toddlers Born Preterm

Overview

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.

Interventions

• Behavioral 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). Parent
• Behavioral 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

Primary outcome measures

• 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)]

Secondary outcome measures (4)

• Maternal depression as measured by the Beck's Depression Inventory [Time frame: Post-test 1 (1-2 weeks post intervention)]
• Degree of chaos in the home as measured by the CHAOS questionnaire [Time frame: Post-test 1 (1-2 weeks post intervention)]
• COVID-19 Exposure and Family Impact as assessed by the COVID-19 Exposure and Family Impact Survey - Exposure Score [Time frame: Post-test 1 (1-2 weeks post intervention)]
• COVID-19 Exposure and Family Impact as assessed by the COVID-19 Exposure and Family Impact Survey - Impact Score [Time frame: Post-test 1 (1-2 weeks post intervention)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT04856501 · HSC-MS-17-0190 · 1R01HD100560-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗