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

Parenting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02428465
• Other study ID #: H-33740
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: December 1, 2018

Study information

• Verified date: December 2018
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Parenting

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts
United States	Dimock Health Center	Roxbury	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	HRSA/Maternal and Child Health Bureau

Country where clinical trial is conducted

United States, 

References & Publications (9)

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

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:S5-25. doi: 10.1542/peds.2012-1427c. Review. — View Citation

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.

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Social and emotional competence	Social and emotional competence will be assessed by the 42-item Brief Infant-Toddler Social and Emotional Assessment (BITSEA). Cronbach's alpha is 0.76, and test-retest reliability is 0.61-0.75. The measure correlates well with the Child Behavior Checklist.	At intervention conclusion (child is 12 months) and 6 months post intervention (child is 18 months)
Other	Child language and communication skills	Parent report of child language and communication skills will be assessed by the MacArthur-Bates Communicative Development Inventories (CDI). The CDI: Words and Gestures, used for children between the ages of 8 and 18 months, documents the child's understanding of early vocabulary items both understood and used, and records the communicative and symbolic gestures. The CDI: Words and Sentences, used for children between the ages of 16 and 30 months, documents the child's production and use of words and analyzes the early phases of grammar. The CDI has excellent test-retest reliability, concurrent validity and correlates well with other measures of child language development.	At intervention conclusion (child is 12 months) and 6 months post intervention (child is 18 months)
Other	Cost	Cost data (e.g., staff time and training; supplies and materials) collected to assess marginal cost of intervention	Collected for duration of the intervention (12 months of intervention per child)
Other	Barriers and Facilitators to Intervention Sustainability	Qualitative interviews with key stakeholders about barriers and facilitators of sustaining intervention	Interviews conducted once at 36 months (study conclusion)
Primary	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)
Primary	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	Parental knowledge of infant/toddler development, health and safety, and positive parenting practices	Parental knowledge of infant/toddler development, health and safety, and positive parenting practices will be assessed by the 75-item Knowledge of Infant Development (KIDI) scale. The scale was developed to be accessible to parents with limited literacy and to be culturally neutral. Cronbach's alpha for parents is 0.82; test-retest reliability for parents is 0.92; validity has also been deemed acceptable.	At intervention conclusion (child is 12 months) and 6 months post intervention (child is 18 months)
Secondary	Parenting stress	Parenting stress will be assessed by the 36-item short form of the Abidin's Parenting Stress Index (PSI), with subscales including perceptions of social isolation, attachment to the child and parental health. Cronbach's alpha is 0.91 for the total scale; six month test-retest coefficients are 0.68-0.85.	At intervention conclusion (child is 12 months) and 6 months post intervention (child is 18 months)
Secondary	Satisfaction and confidence in parenting skills	Satisfaction and confidence in parenting skills will be assessed by the 17-item Parenting Sense of Competency scale. Internal reliability is excellent, with Cronbach's alphas ranging from 0.75-0.88. Two sub-scales measure perceptions of efficacy and satisfaction in the parenting role.	At intervention conclusion (child is 12 months) and 6 months post intervention (child is 18 months)