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OpenTrials
Completed

NCT Number: NCT03530137

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.

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Key information

Conditions

Families Experiencing Homelessness With Children Under 48 Months of Age

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Families Moving Forward

Durham, North Carolina, 27701, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Healthy Home

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).

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

Behavioral

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

Primary outcomes

  1. Feasibility of the intervention as measured by a composite of satisfaction surveys and focus groups with families and staff.

    Time frame: up to 12 months

  2. Changes in parent and child functioning as measured by composite of observation and self-report.

    Time frame: Baseline and 12 months

Secondary outcomes

  1. Sustainability as measured by focus groups of staff

    Time frame: up to 12 months

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 21, 2018
Registry last updated
Oct 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.