Primary Care and Parenting

NCT03146572 | Completed Early Phase 1

• 2 other identifiers: 2014-0337_2SDBP
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study to evaluate potential impact of a brief, low-cost primary care-based intervention of parenting self-efficacy, knowledge, and behavior.

Conditions

Parenting; Knowledge, Attitudes, Practice; Development, Child

Outcome Measures

Primary Outcomes (3)

• Change in Parental Knowledge

  Change in parental knowledge regarding importance of talking with children

  Enrollment and 7 months post-enrollment

• Change in participation in cognitively stimulating activities

  Change in participation in cognitively stimulating activities such as reading and play as measured by the StimQ

  Enrollment and 7 months post-enrollment

• Change in parenting self-efficacy

  Change in perceived self-efficacy in parenting activity as measured by The Tool to Measure Parenting Self Efficacy

  Enrollment and 7 months post-enrollment

Study Arms (2)

Intervention

EXPERIMENTAL

Parent of child to receive intervention, Sit Down and Play

Behavioral: Sit Down and Play

Control

ACTIVE COMPARATOR

Parent will receive handout to promote positive behavior

Other: Handout

Interventions

Sit Down and Play BEHAVIORAL

Sit Down and Play (SDP) is designed to be a brief, low-cost intervention that incorporates key theoretical constructs to elicit positive parenting behaviors. It is intended to be delivered by existing clinical staff, nonprofessionals, or volunteers during each of the eight well-child visits between 2-24 months of age while a family waits to be seen by their pediatrician in the examination room

Also known as: Handout

Intervention

Handout OTHER

Handout providing written descriptions of strategies to encourage positive parenting behaviors

Control

Eligibility Criteria

• Age: 6 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Parent is 18 years or older Child is present for a 6, 9, or 12 month well-child visit who attends University of Illinois at Chicago (UIC) for well-child care Adult present with child at appointment is parent/caregiver of child

You may not qualify if:

• Parent is non-English speaking Child is acutely sick

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Society of Developmental and Behavioral Pediatrics: collaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Behavior

Study Officials

• Reshma Shah, MD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: May 7, 2017
• First Posted: May 10, 2017
• Study Start: April 3, 2017
• Primary Completion: February 11, 2018
• Study Completion: April 6, 2018
• Last Updated: February 13, 2020

Record last verified: 2020-02

Locations

US (1)