Collaboration to Promote Early Childhood Well Being in Families Experiencing Homelessness

NCT ID: NCT03530137

Last Updated: 2019-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-24

Study Completion Date

2019-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Families Experiencing Homelessness With Children Under 48 Months of Age

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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families living at Families Moving Forward (FMF)

Group Type OTHER

Healthy Home

Intervention Type BEHAVIORAL

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).

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Healthy Steps helps families identify, understand and manage parenting challenges like feeding, behavior, sleep, development and adjusting to life with a young child

Interventions

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Healthy Home

An evidence-based health literacy curriculum will be developed and implemented based on competencies of understanding and applying health information. The

Intervention Type 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.

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alison H Edie, DNP

Role: PRINCIPAL_INVESTIGATOR

Duke University

Karen A Carmody, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Families Moving Forward

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00094422

Identifier Type: -

Identifier Source: org_study_id

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