Families Experiencing Homelessness With Children Under 48 Months of AgeNCT03530137
Collaboration to Promote Early Childhood Well Being in Families Experiencing Homelessness
A study testing Healthy Home, Attachment and Biobehavioral Catch-up Infant (6-24 months) and Toddler (24-48 months). and HealthySteps in people with Families Experiencing Homelessness With Children Under 48 Months of Age, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Families Experiencing Homelessness With Children Under 48 Months of Age
- What is being tested?
- Healthy Home, Attachment and Biobehavioral Catch-up Infant (6-24 months) and Toddler (24-48 months). and HealthySteps
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2018to 31 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Non-English speaking subjects
Trial locations and contacts
1 site in 1 country.
United States1 site
Families Moving Forward
Durham, North Carolina, 27701
About this study
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.
- Being tested
- Healthy Home, Attachment and Biobehavioral Catch-up Infant (6-24 months) and Toddler (24-48 months)., HealthySteps
- Keywords
- homelessness, homeless children, homeless families
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy HomeBehavioural
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).Behavioural
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.
HealthyStepsBehavioural
Healthy Steps helps families identify, understand and manage parenting challenges like feeding, behavior, sleep, development and adjusting to life with a young child
| Study group | Role | What they receive |
|---|---|---|
| families living at Families Moving Forward (FMF) | Other | Not described Receives: Behavioral: Healthy Home; Behavioral: Attachment and Biobehavioral Catch-up Infant (6-24 months) and Toddler (24-48 months).; Behavioral: HealthySteps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the intervention as measured by a composite of satisfaction surveys and focus groups with families and staff.
Measured: up to 12 months
Changes in parent and child functioning as measured by composite of observation and self-report.
Measured: Baseline and 12 months
Secondary outcomes (1)
Sustainability as measured by focus groups of staff
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start24 May 2018
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Families Experiencing Homelessness With Children Under 48 Months of AgeStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alison H Edie, DNP, Principal investigator, Duke UniversityKaren A Carmody, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530137
- Sponsor's protocol ID
- Pro00094422
- Status last verified
- Jun 2019
- First submitted
- 8 May 2018
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaboration to Promote Early Childhood Well Being in Families Experiencing Homelessness
- ClinicalTrials.gov ID
- NCT03530137
- Acronym / sponsor ID
- Pro00094422
- Keywords
- homelessness, homeless children, homeless families
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 24 May 2018 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 21 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| families living at Families Moving Forward (FMF) | Other | Behavioral: Healthy Home, Behavioral: Attachment and Biobehavioral Catch-up Infant (6-24 months) and Toddler (24-48 months)., Behavioral: HealthySteps |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Non-English speaking subjects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy HomeAn evidence-based health literacy curriculum will be developed and implemented based on competencies of understanding and applying health information. The | Behavioural | families living at Families Moving Forward (FMF) |
| 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. | Behavioural | families living at Families Moving Forward (FMF) |
| HealthyStepsHealthy Steps helps families identify, understand and manage parenting challenges like feeding, behavior, sleep, development and adjusting to life with a young child | Behavioural | families living at Families Moving Forward (FMF) |
Primary outcome
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
Changes in parent and child functioning as measured by composite of observation and self-report.
Time frame: Baseline and 12 months
1 secondary outcome
Sustainability as measured by focus groups of staff
Time frame: up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison H Edie, DNP principal investigator
Duke University
Karen A Carmody, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Home, Attachment and Biobehavioral Catch-up Infant (6-24 months) and Toddler (24-48 months). and HealthySteps in people with Families Experiencing Homelessness With Children Under 48 Months of Age, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2019.