Collaboration to Promote Early Childhood Well Being in Families Experiencing Homelessness

The purpose of this study is to help us learn what are the best services to promote young children's healthy development for families who are experiencing homelessness. Participants may participate in three programs: 1. Healthy Home: four weekly, one-hour group sessions on health topics; 2. Attachment and Biobehavioral Catch-up (ABC): 10, one-hour parenting with parent and child; 3. Healthy Steps: helps families identify, understand and manage parenting challenges completed at well child visits. Participants will be asked to complete surveys, participate in focus groups, and interviews about the experiences with the services offered. Questionnaires about understanding health issues and surveys about parenting behaviors and self-efficacy will also be completed. Study duration is approximately 10 - 12 weeks. Programs may be continued once families move into permanent housing.

Study Overview

• Status: Completed
• Conditions: Families Experiencing Homelessness With Children Under 48 Months of Age
• Intervention / Treatment: Behavioral: Healthy Home; Behavioral: Attachment and Biobehavioral Catch-up Infant (6-24 months) and Toddler (24-48 months).; Behavioral: HealthySteps

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27701
      • Families Moving Forward

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Head of household of families living at FMF with at least one child under 48 months.
• All subjects must be English speaking and able to give legally effective consent.

Exclusion Criteria:

• Non-English speaking subjects

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: families living at Families Moving Forward (FMF)

Behavioral: Healthy Home; An evidence-based health literacy curriculum will be developed and implemented based on competencies of understanding and applying health information. The; Behavioral: Attachment and Biobehavioral Catch-up Infant (6-24 months) and Toddler (24-48 months).; ABC includes 10 in-home, manualized sessions with parents and infants, targeting: 1) increasing parents' nurturing when children are distressed, 2) helping parents follow children's lead, 3) decreasing frightening parent behaviors, and (for ABC-Toddler) managing dysregulation.; Behavioral: HealthySteps; Healthy Steps helps families identify, understand and manage parenting challenges like feeding, behavior, sleep, development and adjusting to life with a young child

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Feasibility of the intervention as measured by a composite of satisfaction surveys and focus groups with families and staff.	up to 12 months
Changes in parent and child functioning as measured by composite of observation and self-report.	Baseline and 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Sustainability as measured by focus groups of staff	up to 12 months

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Alison H Edie, DNP, Duke University; Principal Investigator: Karen A Carmody, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2018
• Primary Completion (Actual): August 31, 2019
• Study Completion (Actual): August 31, 2019

Study Registration Dates

• First Submitted: May 8, 2018
• First Submitted That Met QC Criteria: May 8, 2018
• First Posted (Actual): May 21, 2018

Study Record Updates

• Last Update Posted (Actual): October 3, 2019
• Last Update Submitted That Met QC Criteria: October 2, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: homelessness; homeless children; homeless families
• Other Study ID Numbers: Pro00094422

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No