Child AbusePhase 2NCT00336193
Competency Training, Staff Performance, & Family Outcomes
A Phase 2 study testing Home visitation in people with Child Abuse, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial summary
This proposal examines the impact of an augmented competency based approach to training of home visitors and supervisors for delivery of the Nurse Family Partnership (NFP) on staff performance, fidelity to the program model, and family outcomes relative to child maltreatment and early behaviors associated with youth… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Child Abuse
- What is being tested?
- Home visitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,075 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Sep 2009
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- First time mothers (enrolled during pregnancy) and their children
Who cannot join
- See above. No other exclusion criteria will be used.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver Health Sciences Center
Denver, Colorado, 80262
About this study
Official title: University of Colorado Health Sciences Center: Competency Training, Staff Performance, & Family Outcomes
This proposal examines the impact of an augmented competency based approach to training of home visitors and supervisors for delivery of the Nurse Family Partnership (NFP) on staff performance, fidelity to the program model, and family outcomes relative to child maltreatment and early behaviors associated with youth violence. The central premise underlying the proposed study is that the augmented competency based curriculum and clinical consultation to supervisors will improve nurses' knowledge and skills in working with families, which in turn, will lead to greater fidelity to the home visit guidelines (i.e., quality implementation), which in turn, will result in better maternal and child health outcomes.
Read the detailed description
A two group experimental design will be used to examine the impact of an augmented competency-based curriculum for NFP home visitors and supervisors coupled with structured clinical consultation by NFP National Office professional development staff, as compared against the standard curriculum currently used, on quality of program implementation and family outcomes.
- Conditions
- Child Abuse
- Being tested
- Home visitation
- Keywords
- home visitation, family outcomes, competency training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home visitationBehavioural
Home visitation to improve maternal health and well-being and parenting practices
| Study group | Role | What they receive |
|---|---|---|
| Home visitation | Experimental | In the intervention condition, nurse home visitors receive enhanced training to improve delivery of parenting interventions to mothers Receives: Behavioral: Home visitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of children's home environment
Measured: 12 and 24 months
Children's emergency room visits/hospitalizations
Measured: 6, 12, 18, and 24 months
Children's adjustment and behavior
Measured: 21-22 months
Children's language development at 21 months
Measured: 21 months
Referrals to child protective services 6, 12, 18, and 24 months
Measured: 6, 12, 18, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2006 (estimated)
- Study startAug 2005
- Primary completionSep 2009
- Study completionSep 2009
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.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,075 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Investigators
- Ruth A O'Brien, RN PhD, Principal investigator, University of Colorado Denver Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00336193
- Sponsor's protocol ID
- CDC-NCIPC-4537
- Status last verified
- Feb 2011
- First submitted
- 10 Jun 2006
- Last updated
- 11 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- University of Colorado Health Sciences Center: Competency Training, Staff Performance, & Family Outcomes
- ClinicalTrials.gov ID
- NCT00336193
- Acronym / sponsor ID
- CDC-NCIPC-4537
- Conditions
- Child Abuse
- Keywords
- home visitation, family outcomes, competency training
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,075 participants (estimated)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Study start
- Aug 2005
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 13 Jun 2006 (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.
This proposal examines the impact of an augmented competency based approach to training of home visitors and supervisors for delivery of the Nurse Family Partnership (NFP) on staff performance, fidelity to the program model, and family outcomes relative to child maltreatment and early behaviors associated with youth violence. The central premise underlying the proposed study is that the augmented competency based curriculum and clinical consultation to supervisors will improve nurses' knowledge and skills in working with families, which in turn, will lead to greater fidelity to the home visit guidelines (i.e., quality implementation), which in turn, will result in better maternal and child health outcomes.
Detailed description
A two group experimental design will be used to examine the impact of an augmented competency-based curriculum for NFP home visitors and supervisors coupled with structured clinical consultation by NFP National Office professional development staff, as compared against the standard curriculum currently used, on quality of program implementation and family outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home visitation | Experimental | Behavioral: Home visitationIn the intervention condition, nurse home visitors receive enhanced training to improve delivery of parenting interventions to mothers |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- First time mothers (enrolled during pregnancy) and their children
Key exclusion criteria (1 listed)
- See above. No other exclusion criteria will be used.
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 |
|---|---|---|
| Home visitationHome visitation to improve maternal health and well-being and parenting practices | Behavioural | Home visitation |
Primary outcome
Assessment of children's home environment
Time frame: 12 and 24 months
Children's emergency room visits/hospitalizations
Time frame: 6, 12, 18, and 24 months
Children's adjustment and behavior
Time frame: 21-22 months
Children's language development at 21 months
Time frame: 21 months
Referrals to child protective services 6, 12, 18, and 24 months
Time frame: 6, 12, 18, and 24 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 11 Feb 2011.
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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.
Ruth A O'Brien, RN PhD principal investigator
University of Colorado Denver Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Home visitation in people with Child Abuse, run by Centers for Disease Control and Prevention 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 1 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 11 Feb 2011. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Assessment of children's home environment (time frame: 12 and 24 months). The study lists 5 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 11 Feb 2011.