Purposeful Parenting: Enhanced Anticipatory Guidance for the First Year of

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Parenting

Clinical Trial Details

NCT number	NCT02428465
Study type	Interventional
Source	Boston Medical Center
Contact
Status	Completed
Phase	N/A
Start date	November 2015
Completion date	December 1, 2018

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms