Child AbuseNCT00216710
Evaluation of the Healthy Families Alaska Program
A study testing Home Visiting in people with Child Abuse, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study will assess the effectiveness of early home visitation by a professional in preventing child maltreatment, promoting healthy family functioning, and promoting child health and development. 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 Visiting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 1999to 21 Jan 2005
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Family resides in a community served by one of six HFAK programs participating in the study
- Family identified as at-risk by HFAK staff following the usual HFAK protocol
Who cannot join
- Family was previously enrolled in HFAK
- Mother unable to speak English well enough to complete study activities.
- Family unwilling to enroll in the HFAK program.
Trial locations and contacts
1 site in 1 country.
About this study
This study will assess the effectiveness of early home visitation by a professional in preventing child maltreatment, promoting healthy family functioning, and promoting child health and development.
The investigators will test the following hypotheses regarding the effectiveness of early paraprofessional home visiting for at-risk families
- Actual home visiting services adhere to HFAK standards.
- HFAK promotes healthy family functioning, promotes child health and development, and prevents child abuse and neglect.
- Adherence to HFAK process standards is positively associated with achievement of outcomes.
Read the detailed description
Healthy Families Alaska (HFAK) is a well-established child abuse prevention program targeted to at-risk families. HFAK is based on the Healthy Families America initiative promoted by Prevent Child Abuse America. The State Department of Health and Social Services (DHSS) administers the HFAK program.
In 1998, the Alaska State Legislature requested a controlled study of HFAK to determine its effectiveness in preventing child maltreatment, promoting healthy family functioning, and promoting child health and development. DHSS awarded the Johns Hopkins University School of Medicine a contract to conduct the study from July 1999 through June 2004.
The study is a randomized trial of six HFAK sites throughout Alaska. It aims to compare services actually provided to HFAK standards, assess program success in achieving intended outcomes, and relate program impact to service delivery.
Families are enrolled over 21 months beginning in January 2000. Families are randomized to either the HFAk group or the control group. Baseline data on family attributes are collected from HFAK files and maternal interviews. HFAK service data are collected from the program's management information system, record reviews, surveys of staff, and staff focus groups. Outcome data are collected when the children were two years old through maternal interview, home-based observations, child developmental testing, review of medical records, and review of OCS child welfare records.
- Conditions
- Child Abuse
- Being tested
- Home Visiting
- Keywords
- Child abuse, Neglect, Home visitation, Program evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home VisitingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Home Visited Mothers | Experimental | Mothers randomized to the home visited group received AK State-funded home visiting services. Frequency of home visits was determined by home visiting staff based on mothers' needs. Mothers could receive home visiting services until their child turned 3 years old Receives: Behavioral: Home Visiting |
| Control Mothers | No intervention | Mothers randomized to the control group did not receive home visiting services, but were offered referrals to other community-based services, as was usual protocol with home visiting agencies were operating at capacity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Abuse and Neglect
Substantiated and unsubstantiated reports of abuse; maternal self-report of harsh discipline
Measured: From child's birth (baseline) to 24 months of age
Child Development
Child cognitive, motor and psychosocial development
Measured: 24 months
Secondary outcomes (6)
Child Health
Hospitalizations, ED use, injuries requiring medical care, adequate well child care, immunizations
Measured: From child's birth (baseline) to 24 months of age
Maternal Life Course
Educational attainment, employment, social support, rapid repeat birth
Measured: At time of study follow-up (child 24 months of age)
Maternal Psychosocial Functioning
Mental health, substance use, intimate partner violence
Measured: At time of study follow-up (child 24 months of age)
Parenting Knowledge
Knowledge of child development; recognition of child delay
Measured: At time of study follow-up (child 24 months of age)
Parenting Attitudes
Use of corporal punishment, infant caregiving, expectations of children, empathy towards child's needs
Measured: At time of study follow-up (child 24 months of age)
Parenting Behavior
Observational measures of parent/child interaction and quality of the home environment, use of corporal punishment, use of nonviolent discipline
Measured: At time of study follow-up (child 24 months of age)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJul 1999
- Primary completion21 Feb 2004
- Study completion21 Jan 2005
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 Johns Hopkins 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
- Single group
- Masking
- None (open label)
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- State of Alaska Department of Health and Social Services
- Investigators
- Anne K Duggan, ScD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00216710
- Sponsor's protocol ID
- 99-0155
- Other IDs
- Contract Number 067727
- Status last verified
- Aug 2017
- First submitted
- 16 Sep 2005
- Last updated
- 30 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Healthy Families Alaska Program
- ClinicalTrials.gov ID
- NCT00216710
- Acronym / sponsor ID
- 99-0155
- Conditions
- Child Abuse
- Keywords
- Child abuse, Neglect, Home visitation, Program evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- State of Alaska Department of Health and Social Services
- Study start
- Jul 1999
- Primary completion
- 21 Feb 2004 (actual)
- Study completion
- 21 Jan 2005 (actual)
- First posted
- 22 Sep 2005 (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 study will assess the effectiveness of early home visitation by a professional in preventing child maltreatment, promoting healthy family functioning, and promoting child health and development.
The investigators will test the following hypotheses regarding the effectiveness of early paraprofessional home visiting for at-risk families
- Actual home visiting services adhere to HFAK standards.
- HFAK promotes healthy family functioning, promotes child health and development, and prevents child abuse and neglect.
- Adherence to HFAK process standards is positively associated with achievement of outcomes.
Detailed description
Healthy Families Alaska (HFAK) is a well-established child abuse prevention program targeted to at-risk families. HFAK is based on the Healthy Families America initiative promoted by Prevent Child Abuse America. The State Department of Health and Social Services (DHSS) administers the HFAK program.
In 1998, the Alaska State Legislature requested a controlled study of HFAK to determine its effectiveness in preventing child maltreatment, promoting healthy family functioning, and promoting child health and development. DHSS awarded the Johns Hopkins University School of Medicine a contract to conduct the study from July 1999 through June 2004.
The study is a randomized trial of six HFAK sites throughout Alaska. It aims to compare services actually provided to HFAK standards, assess program success in achieving intended outcomes, and relate program impact to service delivery.
Families are enrolled over 21 months beginning in January 2000. Families are randomized to either the HFAk group or the control group. Baseline data on family attributes are collected from HFAK files and maternal interviews. HFAK service data are collected from the program's management information system, record reviews, surveys of staff, and staff focus groups. Outcome data are collected when the children were two years old through maternal interview, home-based observations, child developmental testing, review of medical records, and review of OCS child welfare records.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home Visited Mothers | Experimental | Behavioral: Home VisitingMothers randomized to the home visited group received AK State-funded home visiting services. Frequency of home visits was determined by home visiting staff based on mothers' needs. Mothers could receive home visiting services until their child turned 3 years old |
| Control Mothers | No intervention | –Mothers randomized to the control group did not receive home visiting services, but were offered referrals to other community-based services, as was usual protocol with home visiting agencies were operating at capacity. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Family resides in a community served by one of six HFAK programs participating in the study
- Family identified as at-risk by HFAK staff following the usual HFAK protocol
Key exclusion criteria (3 listed)
- Family was previously enrolled in HFAK
- Mother unable to speak English well enough to complete study activities.
- Family unwilling to enroll in the HFAK program.
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 Visiting | Behavioural | Home Visited Mothers |
Primary outcome
Child Abuse and Neglect
Time frame: From child's birth (baseline) to 24 months of age
Substantiated and unsubstantiated reports of abuse; maternal self-report of harsh discipline
Child Development
Time frame: 24 months
Child cognitive, motor and psychosocial development
6 secondary outcomes
Child Health
Time frame: From child's birth (baseline) to 24 months of age
Maternal Life Course
Time frame: At time of study follow-up (child 24 months of age)
Maternal Psychosocial Functioning
Time frame: At time of study follow-up (child 24 months of age)
Parenting Knowledge
Time frame: At time of study follow-up (child 24 months of age)
Parenting Attitudes
Time frame: At time of study follow-up (child 24 months of age)
Parenting Behavior
Time frame: At time of study follow-up (child 24 months of age)
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 30 Aug 2017.
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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.
Anne K Duggan, ScD principal investigator
Johns Hopkins 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 Home Visiting in people with Child Abuse, run by Johns Hopkins 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 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 30 Aug 2017. 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 Abuse and Neglect (time frame: From child's birth (baseline) to 24 months of age). 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 30 Aug 2017.