Child MaltreatmentNCT01304719
A Computer-based Intervention to Augment Home Visitation Services: The E-Parenting Project
A study testing Computer Assisted Healthy Families America Home Visitation and Healthy Families America Home Visitation in people with Child Maltreatment, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial summary
The current protocol aims to examine the effects of a computer-based intervention used in conjunction with existing Healthy Families America (HFA) home visitation programs on the challenges related to participant enrollment, retention, and motivation as well as parent and child outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Child Maltreatment
- What is being tested?
- Computer Assisted Healthy Families America Home Visitation and Healthy Families America Home Visitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 413 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Aug 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant or post-partum mothers who are eligible (i.e., score 25 or greater on the Kempe Family Stress Checklist and are not involved in CPS open case investigation at the time of HFA participation) and willing to participate in the HFA program are eligible to participate in the current study, with the following restrictions:
- Mothers must be 18 years or older and able to complete the baseline assessment within 4 weeks of delivery.
- Mothers have not completed any prior post-partum treatment plan.
- Participants must have functional cognitive abilities.
- Premature infants have to be released from hospital care within 6 weeks of birth.
- Participants must be able to communicate in English.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The current protocol aims to examine the effects of a computer-based intervention used in conjunction with existing Healthy Families America (HFA) home visitation programs on the challenges related to participant enrollment, retention, and motivation as well as parent and child outcomes.
Read the detailed description
The present study aims to determine whether a computer-based intervention can provide augmentation of home visiting services to decrease the risk of child maltreatment. The computer-based software includes modules on motivation, Cognitive Retraining, and elements of the ecobehavioral SafeCare approach. A total of 420 mother-infant dyads from four Healthy Families America (HFA) sites will be randomly assigned to either treatment as usual, software-supplemented home visitation, or community control conditions. For families in the software-supplemented condition, home visitors will present the software to parents via a Tablet PC during regular home visits. All parents will be followed-up at 6, 12, and 18 months by independent and blinded research assistants. Parents are evaluated for maltreatment and maltreatment risks as measured by self-report, home visitor report, blinded independent observers, and statewide CPS data. If validated, the proposed intervention can provide augmentation of home visiting services with unprecedented ease of dissemination, at negligible additional cost, and with limitless potential for further development.
- Conditions
- Child Maltreatment
- Being tested
- Computer Assisted Healthy Families America Home Visitation, Healthy Families America Home Visitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer Assisted Healthy Families America Home VisitationBehavioural
Computer modules added to home visitation protocol for Healthy Families America
Healthy Families America Home VisitationBehavioural
Healthy Families America Home Visitation Treatment as Usual
| Study group | Role | What they receive |
|---|---|---|
| Computer Assisted home visitation | Experimental | Home visitation with computer modules added Receives: Behavioral: Computer Assisted Healthy Families America Home Visitation |
| Home Visitation TAU | Experimental | Home Visitation Treatment as Usual Receives: Behavioral: Healthy Families America Home Visitation |
| Community Referral | No intervention | Community Referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child maltreatment reports
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startOct 2007
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child MaltreatmentStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 413 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Steven Ondersma, Ph.D., Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304719
- Sponsor's protocol ID
- 092506B3F
- Status last verified
- May 2013
- First submitted
- 10 Feb 2011
- Last updated
- 15 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Computer-based Intervention to Augment Home Visitation Services: The E-Parenting Project
- ClinicalTrials.gov ID
- NCT01304719
- Acronym / sponsor ID
- 092506B3F
- Conditions
- Child Maltreatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 413 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Study start
- Oct 2007
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 25 Feb 2011 (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 current protocol aims to examine the effects of a computer-based intervention used in conjunction with existing Healthy Families America (HFA) home visitation programs on the challenges related to participant enrollment, retention, and motivation as well as parent and child outcomes.
Detailed description
The present study aims to determine whether a computer-based intervention can provide augmentation of home visiting services to decrease the risk of child maltreatment. The computer-based software includes modules on motivation, Cognitive Retraining, and elements of the ecobehavioral SafeCare approach. A total of 420 mother-infant dyads from four Healthy Families America (HFA) sites will be randomly assigned to either treatment as usual, software-supplemented home visitation, or community control conditions. For families in the software-supplemented condition, home visitors will present the software to parents via a Tablet PC during regular home visits. All parents will be followed-up at 6, 12, and 18 months by independent and blinded research assistants. Parents are evaluated for maltreatment and maltreatment risks as measured by self-report, home visitor report, blinded independent observers, and statewide CPS data. If validated, the proposed intervention can provide augmentation of home visiting services with unprecedented ease of dissemination, at negligible additional cost, and with limitless potential for further development.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Computer Assisted home visitation | Experimental | Behavioral: Computer Assisted Healthy Families America Home VisitationHome visitation with computer modules added |
| Home Visitation TAU | Experimental | Behavioral: Healthy Families America Home VisitationHome Visitation Treatment as Usual |
| Community Referral | No intervention | –Community Referral |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pregnant or post-partum mothers who are eligible (i.e., score 25 or greater on the Kempe Family Stress Checklist and are not involved in CPS open case investigation at the time of HFA participation) and willing to participate in the HFA program are eligible to participate in the current study, with the following restrictions:
- Mothers must be 18 years or older and able to complete the baseline assessment within 4 weeks of delivery.
- Mothers have not completed any prior post-partum treatment plan.
- Participants must have functional cognitive abilities.
- Premature infants have to be released from hospital care within 6 weeks of birth.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Computer Assisted Healthy Families America Home VisitationComputer modules added to home visitation protocol for Healthy Families America | Behavioural | Computer Assisted home visitation |
| Healthy Families America Home VisitationHealthy Families America Home Visitation Treatment as Usual | Behavioural | Home Visitation TAU |
Primary outcome
Child maltreatment reports
Time frame: 18 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 15 May 2013.
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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.
Steven Ondersma, Ph.D. principal investigator
Wayne State 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 Computer Assisted Healthy Families America Home Visitation and Healthy Families America Home Visitation in people with Child Maltreatment, 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 6 inclusion and 0 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 15 May 2013. 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?
Child maltreatment reports (time frame: 18 months). 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 15 May 2013.