Collaboration to Promote Early Childhood Well Being in Families Experiencing Homelessness

Families Experiencing Homelessness With Children Under 48 Months of Age Clinical Trial

Official title:

Collaboration to Promote Early Childhood Well Being in Families Experiencing Homelessness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03530137
• Other study ID #: Pro00094422
• Status: Completed
• Phase: N/A
• Start date: May 24, 2018
• Est. completion date: August 31, 2019

Study information

• Verified date: June 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Families Experiencing Homelessness With Children Under 48 Months of Age

Intervention

Behavioral:
• Healthy Home
An evidence-based health literacy curriculum will be developed and implemented based on competencies of understanding and applying health information. The
• 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.
• HealthySteps
Healthy Steps helps families identify, understand and manage parenting challenges like feeding, behavior, sleep, development and adjusting to life with a young child

Locations

Country	Name	City	State
United States	Families Moving Forward	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the intervention as measured by a composite of satisfaction surveys and focus groups with families and staff.		up to 12 months
Primary	Changes in parent and child functioning as measured by composite of observation and self-report.		Baseline and 12 months
Secondary	Sustainability as measured by focus groups of staff		up to 12 months