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Clinical Trials/NCT02428465
NCT02428465
Completed
N/A

Purposeful Parenting: Enhanced Anticipatory Guidance for the First Year of Life

Boston Medical Center2 sites in 1 country290 target enrollmentNovember 2015
ConditionsParenting

Overview

Phase
N/A
Intervention
Not specified
Conditions
Parenting
Sponsor
Boston Medical Center
Enrollment
290
Locations
2
Primary Endpoint
Responsive Parenting
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Pediatricians' provision of parenting-focused anticipatory guidance often does not meet parents' needs; the few studies that have investigated primary-care based strategies to promote positive parenting rely on time-intensive, high-cost interventions, thereby limiting their generalizability. Therefore, the Purposeful Parenting was developed as a universal program of enhanced anticipatory guidance. At each well-child visit in the first year of a child's life, Purposeful Parenting provides parents with: 1) scripted anticipatory guidance and handouts focused on the child's emerging social-emotional and linguistic (SEL) skills, brain development and the importance of responsive parenting; and 2) a "reminder" item (e.g., a "Smile at Me" onesie) that allows for in-office role modeling and promotes practicing of an age-specific, nurturing parent-child interaction. If an in-office intervention is missed (e.g. parent cancels visit, interventionist out sick) the intervention will be delivered by telephone if possible by the site-based clinical interventionists and the "reminder" items will be mailed.

Detailed Description

The investigators will conduct a two-phase study. Phase I (months 1-4) will entail a brief pilot of Purposeful Parenting in three Boston-based health centers to optimize quality and logistical details. Phase II (months 5-36) will determine, with a parallel group randomized controlled trial (RCT), whether delivering Purposeful Parenting leads to increased responsive parenting at the intervention's conclusion (in intervention vs control parents), assessed using a validated observational measure. The investigators will enroll 260 low-income families with a full term newborn infant who present for well-child care. Families randomized to the control group will receive usual anticipatory guidance at each well-child visit in the first 12 months of life. Families randomized to the intervention group will receive usual anticipatory guidance plus Purposeful Parenting. As secondary outcomes, the investigators will explore the degree to which Purposeful Parenting (in intervention vs control parents) increases parental knowledge about responsive parenting and child development, reduces parenting stress and improves perceptions of parenting self-efficacy (via validated parental self-report measures) at the conclusion of the intervention. Investigators will explore potential differences by study group in child SEL development at the conclusion of the intervention. In addition, investigators will examine differences in the above listed outcomes are 6 months following the intervention. The RCT will include the collection of process level data including cost.

Registry
clinicaltrials.gov
Start Date
November 2015
End Date
December 1, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Megan Bair-Merritt

Associate Professor of Pediatrics

Boston Medical Center

Eligibility Criteria

Inclusion Criteria

  • Families (parent \>=18 years of age) with a newborn, born at \>= 34 weeks, presenting for well-child care
  • Family plans to remain at that practice
  • English or Spanish speaking

Exclusion Criteria

  • Debilitating chronic condition; prematurity (\<34 weeks gestation)

Outcomes

Primary Outcomes

Responsive Parenting

Time Frame: 6 months post intervention (child is 18 months)

Responsive parenting will be assessed using the Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLOTM), which involves an observer watching a 10 minute videotaped interaction to assess interaction between a parent and her infant or toddler. The PICCOLO is well-validated with inter-rater reliability=0.77; scale reliability=0.78; content, construct and predictive validity are acceptable.

Secondary Outcomes

  • Parental knowledge of infant/toddler development, health and safety, and positive parenting practices(At intervention conclusion (child is 12 months) and 6 months post intervention (child is 18 months))
  • Parenting stress(At intervention conclusion (child is 12 months) and 6 months post intervention (child is 18 months))
  • Satisfaction and confidence in parenting skills(At intervention conclusion (child is 12 months) and 6 months post intervention (child is 18 months))

Study Sites (2)

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