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

NCT ID: NCT02428465

Last Updated: 2018-12-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 290 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2018-12-01

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.

Conditions

Parenting

Keywords

Purposeful Parenting; Parenting stress; Social-emotional and linguistic (SEL) skills

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Purposeful Parenting

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

Group Type: EXPERIMENTAL

Purposeful Parenting

Intervention Type: BEHAVIORAL

Purposeful Parenting reinforces responsive interactions that help promote emerging developmental skills. This information is presented over the course of a child's first 12 months, such that core lessons are the same but specific skills are designed to be developmentally appropriate. This repetitiveness, along with the provision of age-appropriate behavioral guidance, will allow parents to successfully engage in responsive interactions with their children.

Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Purposeful Parenting

Purposeful Parenting reinforces responsive interactions that help promote emerging developmental skills. This information is presented over the course of a child's first 12 months, such that core lessons are the same but specific skills are designed to be developmentally appropriate. This repetitiveness, along with the provision of age-appropriate behavioral guidance, will allow parents to successfully engage in responsive interactions with their children.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

HRSA/Maternal and Child Health Bureau

FED

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Megan Bair-Merritt

Associate Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Megan H Bair-Merritt, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

Boston Medical Center

Boston, Massachusetts, United States

Dimock Health Center

Roxbury, Massachusetts, United States

Countries

United States

References

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Reference Type: BACKGROUND

PMID: 23457149 (View on PubMed)

Magar NA, Dabova-Missova S, Gjerdingen DK. Effectiveness of targeted anticipatory guidance during well-child visits: a pilot trial. J Am Board Fam Med. 2006 Sep-Oct;19(5):450-8. doi: 10.3122/jabfm.19.5.450.

Reference Type: BACKGROUND

PMID: 16951294 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 24023626 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 11324663 (View on PubMed)

MacPhee D. Knowledge of infant development inventory. Chapel Hill, NC: University of North Carolina; 1981.

Reference Type: BACKGROUND

Abidin R. Parenting Stress Index: Professional Manual. 3rd ed. Odessa, FL: Psychological Assessment Resources; 1995.

Reference Type: BACKGROUND

Gilmore L, Cuskelly M. Factor structure of the Parenting Sense of Competence scale using a normative sample. Child Care Health Dev. 2009 Jan;35(1):48-55. doi: 10.1111/j.1365-2214.2008.00867.x. Epub 2008 Oct 22.

Reference Type: BACKGROUND

PMID: 18991983 (View on PubMed)

Other Identifiers

H-33740

Identifier Type: -

Identifier Source: org_study_id