Clinical trial NCT02428465: Purposeful Parenting: Enhanced Anticipatory Guidance for the First Year of Life
Official title: Purposeful Parenting: Enhanced Anticipatory Guidance for the First Year of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parenting
Keywords: Purposeful Parenting
Parenting stress
Social-emotional and linguistic (SEL) skills
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: HRSA/Maternal and Child Health Bureau
First posted: 2015-04-28
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Responsive Parenting
timeFrame: At intervention conclusion (child is 12 months)
measure: Responsive Parenting
timeFrame: 6 months post intervention (child is 18 months)
Secondary outcomes:
measure: Parental knowledge of infant/toddler development, health and safety, and positive parenting practices
timeFrame: At intervention conclusion (child is 12 months) and 6 months post intervention (child is 18 months)
measure: Parenting stress
timeFrame: At intervention conclusion (child is 12 months) and 6 months post intervention (child is 18 months)
measure: Satisfaction and confidence in parenting skills
timeFrame: At intervention conclusion (child is 12 months) and 6 months post intervention (child is 18 months)
Other outcomes:
measure: Social and emotional competence
timeFrame: At intervention conclusion (child is 12 months) and 6 months post intervention (child is 18 months)
measure: Child language and communication skills
timeFrame: At intervention conclusion (child is 12 months) and 6 months post intervention (child is 18 months)
measure: Cost
timeFrame: Collected for duration of the intervention (12 months of intervention per child)
measure: Barriers and Facilitators to Intervention Sustainability
timeFrame: Interviews conducted once at 36 months (study conclusion)
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Roxbury
country: United States
facility: Dimock Health Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Megan H Bair-Merritt, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coker TR, Windon A, Moreno C, Schuster MA, Chung PJ. Well-child care clinical practice redesign for young children: a systematic review of strategies and tools. Pediatrics. 2013 Mar;131 Suppl 1(Suppl 1):S5-25. doi: 10.1542/peds.2012-1427c.
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