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

NCT02428465 | Completed

• 1 other identifier: H-33740
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 2

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.

Conditions

Parenting

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Responsive Parenting

  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.

  At intervention conclusion (child is 12 months)

• Responsive Parenting

  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.

  6 months post intervention (child is 18 months)

Secondary Outcomes (3)

• 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)

Other Outcomes (4)

• Social and emotional competence

  At intervention conclusion (child is 12 months) and 6 months post intervention (child is 18 months)

• Child language and communication skills

  At intervention conclusion (child is 12 months) and 6 months post intervention (child is 18 months)

• Cost

  Collected for duration of the intervention (12 months of intervention per child)

Study Arms (2)

Purposeful Parenting

EXPERIMENTAL

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

Behavioral: Purposeful Parenting

Control Group

NO INTERVENTION

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.

Interventions

Purposeful Parenting 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.

Purposeful Parenting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Boston Medical Center: lead
• HRSA/Maternal and Child Health Bureau: collaborator

Study Sites (2)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Dimock Health Center

Roxbury, Massachusetts, 02119, United States

Location

Related Publications (9)

• 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.

  PMID: 23457149 BACKGROUND

• 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.

  PMID: 16951294 BACKGROUND

• Olson LM, Inkelas M, Halfon N, Schuster MA, O'Connor KG, Mistry R. Overview of the content of health supervision for young children: reports from parents and pediatricians. Pediatrics. 2004 Jun;113(6 Suppl):1907-16.

  PMID: 15173461 BACKGROUND

• Cook GA, Innocenti MS, Roggman LA, Jump Norman VK. PICCOLO: A simple parent-child interaction measure and its use in early intervention. New York, 2011.

  BACKGROUND

• Kruizinga I, Jansen W, Mieloo CL, Carter AS, Raat H. Screening accuracy and clinical application of the Brief Infant-Toddler Social and Emotional Assessment (BITSEA). PLoS One. 2013 Aug 30;8(8):e72602. doi: 10.1371/journal.pone.0072602. eCollection 2013.

  PMID: 24023626 BACKGROUND

• Rescorla L, Alley A. Validation of the language development survey (LDS): a parent report tool for identifying language delay in toddlers. J Speech Lang Hear Res. 2001 Apr;44(2):434-45. doi: 10.1044/1092-4388(2001/035).

  PMID: 11324663 BACKGROUND

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

  BACKGROUND

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

  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.

  PMID: 18991983 BACKGROUND

Study Officials

• Megan H Bair-Merritt, MD, MSCE

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: April 8, 2015
• First Posted: April 28, 2015
• Study Start: November 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 28, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)