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

Boston Medical Center (BMC)

Status: Completed

Conditions: Parenting

Treatments: Behavioral: Purposeful Parenting

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02428465

H-33740

Details and patient eligibility

About

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.

Full 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.

Enrollment: 290 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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290 participants in 2 patient groups

Purposeful Parenting

Experimental group

Description:

Families randomized to the intervention group will receive their pediatric provider's usual anticipatory guidance plus Purposeful Parenting.

Treatment:

Behavioral: Purposeful Parenting

Control Group

No Intervention group

Description:

Families randomized to the control group will receive usual anticipatory guidance, delivered at the discretion of their pediatric provider, at each well-child visit in the first 12 months of life.