Child AbuseNCT00579449
Evaluation of a Home Visiting Program for First Time Parents
A study testing Healthy Families Durham and Yearly Checkup in people with Child Abuse, run by Duke University at 1 site in United States.
Trial summary
The purpose of this research is to evaluate the Healthy Families Durham (HFD) program by comparing the traditional 3-year program to 18-months of Healthy Families Durham to Yearly Visits with case management referrals to community services as usual, and to determine whether participation in the program reduces the… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Child Abuse
- What is being tested?
- Healthy Families Durham and Yearly Checkup
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 343 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Dec 2011
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- mother is a first-time parent (has been a primary caregiver of a child for less than 3 months total
- resident of Durham, North Carolina
- mother is being referred during pregnancy
- has at least one of the following risk factors: 16 years old or younger; lack of social support; history of substance abuse in the past 12 months; ever received treatment for alcohol or drug problems; history of domestic violence; history of being abused or neglected as a child; history of mental health problems in past 12 months; past child protective services involvement as a parent
Who cannot join
- actively suicidal or homicidal
- acutely psychotic
- moderately to severely mentally retarded
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Child and Family Health
Durham, North Carolina, 27701
About this study
The purpose of this research is to evaluate the Healthy Families Durham (HFD) program by comparing the traditional 3-year program to 18-months of Healthy Families Durham to Yearly Visits with case management referrals to community services as usual, and to determine whether participation in the program reduces the number of reports for child maltreatment within the first seven years of the child's life.
- Conditions
- Child Abuse
- Being tested
- Healthy Families Durham, Yearly Checkup
- Keywords
- child abuse, child neglect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Families DurhamBehavioural
Implementation of Healthy Families America program plus Parents As Teachers curriculum
Yearly CheckupBehavioural
Also called case management
Mother and child are assessed annually and based on responses and stated needs, referrals to community resources are made.
| Study group | Role | What they receive |
|---|---|---|
| HF 36 | Active comparator | For those randomly assigned to the 3-year HFD group, services begin during the third trimester of pregnancy. These families are assigned a Family Support Worker, who begins to initiate contact with the family at approximately 6 months gestation, when possible, so that the family can be engaged and services begun at seven months gestation. The Family Support Worker will provide home visiting services according the existing HFD model, which combines the empirically supported Parents as Teachers Curriculum (see attached description of the Parents as Teachers curriculum) provided in accordance with Healthy Families America standards of service delivery. The 3-year HFD group will receive services to the child's third birthday. Receives: Behavioral: Healthy Families Durham |
| HF 18 | Active comparator | For those randomly assigned to the 18-month HFD group, services begin during the third trimester of pregnancy. These families are assigned a Family Support Worker, who begins to initiate contact with the family at approximately 6 months gestation, so that the family can be engaged and services begun at seven months gestation. The Family Support Worker will provide home visiting services according the existing HFD model, which combines the empirically supported Parents as Teachers Curriculum (see attached description of the Parents as Teachers curriculum) provided in accordance with Healthy Families America standards of service delivery. Services for this group are terminated when the child is 18 months old, with clinically necessary referrals made for ongoing psychosocial and health needs. Receives: Behavioral: Healthy Families Durham |
| YC | Active comparator | For those assigned to the Yearly Checkup group, a clinically-trained member of the HFD team will make yearly home visits to conduct the evaluation assessment. Information about community services and assistance with referrals are provided based on needs identified. Receives: Behavioral: Yearly Checkup |
| MCC | No intervention | Women placed in the community services as usual (Maternity Care Coordination only) group will receive no additional services or assessments as a part of this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Durham County, North Carolina Department of Social Services reports of child maltreatment
Measured: 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study startMar 2005
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child AbuseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 343 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), The Duke Endowment
- Responsible party
- Sponsor
- Investigators
- Robert Murphy, Ph.D., Principal investigator, Duke UniversityKenneth Dodge, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00579449
- Sponsor's protocol ID
- Pro00014616
- Other IDs
- 5K01MH70378-3, 6997, 5K01MH070378
- Status last verified
- Sep 2014
- First submitted
- 20 Dec 2007
- Last updated
- 22 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Home Visiting Program for First Time Parents
- ClinicalTrials.gov ID
- NCT00579449
- Acronym / sponsor ID
- Pro00014616
- Conditions
- Child Abuse
- Keywords
- child abuse, child neglect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 343 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), The Duke Endowment
- Study start
- Mar 2005
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 24 Dec 2007 (estimated)
- 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 research is to evaluate the Healthy Families Durham (HFD) program by comparing the traditional 3-year program to 18-months of Healthy Families Durham to Yearly Visits with case management referrals to community services as usual, and to determine whether participation in the program reduces the number of reports for child maltreatment within the first seven years of the child's life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HF 36 | Active comparator | Behavioral: Healthy Families DurhamFor those randomly assigned to the 3-year HFD group, services begin during the third trimester of pregnancy. These families are assigned a Family Support Worker, who begins to initiate contact with the family at approximately 6 months gestation, when possible, so that the family can be engaged and services begun at seven months gestation. The Family Support Worker will provide home visiting services according the existing HFD model, which combines the empirically supported Parents as Teachers Curriculum (see attached description of the Parents as Teachers curriculum) provided in accordance with Healthy Families America standards of service delivery. The 3-year HFD group will receive services to the child's third birthday. |
| HF 18 | Active comparator | Behavioral: Healthy Families DurhamFor those randomly assigned to the 18-month HFD group, services begin during the third trimester of pregnancy. These families are assigned a Family Support Worker, who begins to initiate contact with the family at approximately 6 months gestation, so that the family can be engaged and services begun at seven months gestation. The Family Support Worker will provide home visiting services according the existing HFD model, which combines the empirically supported Parents as Teachers Curriculum (see attached description of the Parents as Teachers curriculum) provided in accordance with Healthy Families America standards of service delivery. Services for this group are terminated when the child is 18 months old, with clinically necessary referrals made for ongoing psychosocial and health needs. |
| YC | Active comparator | Behavioral: Yearly CheckupFor those assigned to the Yearly Checkup group, a clinically-trained member of the HFD team will make yearly home visits to conduct the evaluation assessment. Information about community services and assistance with referrals are provided based on needs identified. |
| MCC | No intervention | –Women placed in the community services as usual (Maternity Care Coordination only) group will receive no additional services or assessments as a part of this study. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- mother is a first-time parent (has been a primary caregiver of a child for less than 3 months total
- resident of Durham, North Carolina
- mother is being referred during pregnancy
- has at least one of the following risk factors: 16 years old or younger; lack of social support; history of substance abuse in the past 12 months; ever received treatment for alcohol or drug problems; history of domestic violence; history of being abused or neglected as a child; history of mental health problems in past 12 months; past child protective services involvement as a parent
Key exclusion criteria (3 listed)
- actively suicidal or homicidal
- acutely psychotic
- moderately to severely mentally retarded
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 Families DurhamImplementation of Healthy Families America program plus Parents As Teachers curriculum | Behavioural | HF 18, HF 36 |
| Yearly CheckupAlso: case managementMother and child are assessed annually and based on responses and stated needs, referrals to community resources are made. | Behavioural | YC |
Primary outcome
Durham County, North Carolina Department of Social Services reports of child maltreatment
Time frame: 2011
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 22 Sep 2014.
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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.
Robert Murphy, Ph.D. principal investigator
Duke University
Kenneth Dodge, Ph.D. 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 Families Durham and Yearly Checkup in people with Child Abuse, 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 4 inclusion and 3 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 22 Sep 2014. 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?
Durham County, North Carolina Department of Social Services reports of child maltreatment (time frame: 2011). 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 22 Sep 2014.