Domestic ViolencePhase 1NCT00164268
Ke Ala Lokahi Demonstration Project for Sexual and Domestic Violence Prevention
A Phase 1 study testing Ke Ala Lokahi (Native Hawaiian cultural intervention) in people with Domestic Violence, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial summary
The purpose of the project is to examine the efficacy of a culturally-based intervention, compared to standard agency services, in enhancing self-care among Native Hawaiian women and decreasing IPV/SV perpetration and related factors among Native Hawaiian men. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Domestic Violence
- What is being tested?
- Ke Ala Lokahi (Native Hawaiian cultural intervention)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Aug 2005
- Phase
- Phase 1
- 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
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Men and women self-identified as Native Hawaiian referred for agency services due to intimate partner or sexual violence
Who cannot join
- See above. No other exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ke Ala Lokahi Demonstration Project for the Early Intervention and Prevention of Sexual and Domestic Violence Among Racial and Ethnic Populations
The purpose of the project is to examine the efficacy of a culturally-based intervention, compared to standard agency services, in enhancing self-care among Native Hawaiian women and decreasing IPV/SV perpetration and related factors among Native Hawaiian men.
Read the detailed description
Turning Point for Families in Hilo, Hawaii is developing, implementing, and evaluating a culturally-based intervention using Native Hawaiian values, beliefs, and practices to address intimate partner and sexual violence among Native Hawaiian perpetrators and victims/survivors.
- Conditions
- Domestic Violence
- Being tested
- Ke Ala Lokahi (Native Hawaiian cultural intervention)
- Keywords
- Intimate partner violence, Sexual violence, Cultural intervention, Native Hawaiian
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ke Ala Lokahi (Native Hawaiian cultural intervention)Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Subsequent incidents of intimate partner or sexual violence for up to 2 years post-intervention
Secondary outcomes (1)
Attitudes, behaviors, and cultural identity assessed at 3-months, 6-months, and 15-months following treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startOct 2002
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Domestic ViolenceStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Investigators
- Linda Slutter, Principal investigator, Turning Point for Families
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00164268
- Sponsor's protocol ID
- CDC-NCIPC-11249
- Other IDs
- US4/CCU919035-02
- Status last verified
- Sep 2007
- First submitted
- 9 Sep 2005
- Last updated
- 10 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ke Ala Lokahi Demonstration Project for the Early Intervention and Prevention of Sexual and Domestic Violence Among Racial and Ethnic Populations
- ClinicalTrials.gov ID
- NCT00164268
- Acronym / sponsor ID
- CDC-NCIPC-11249
- Conditions
- Domestic Violence
- Keywords
- Intimate partner violence, Sexual violence, Cultural intervention, Native Hawaiian
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Study start
- Oct 2002
- Study completion
- Aug 2005 (actual)
- First posted
- 14 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.
The purpose of the project is to examine the efficacy of a culturally-based intervention, compared to standard agency services, in enhancing self-care among Native Hawaiian women and decreasing IPV/SV perpetration and related factors among Native Hawaiian men.
Detailed description
Turning Point for Families in Hilo, Hawaii is developing, implementing, and evaluating a culturally-based intervention using Native Hawaiian values, beliefs, and practices to address intimate partner and sexual violence among Native Hawaiian perpetrators and victims/survivors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women self-identified as Native Hawaiian referred for agency services due to intimate partner or sexual violence
Key exclusion criteria (1 listed)
- See above. No other exclusion criteria.
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 |
|---|---|---|
| Ke Ala Lokahi (Native Hawaiian cultural intervention) | Behavioural | – |
Primary outcome
Subsequent incidents of intimate partner or sexual violence for up to 2 years post-intervention
1 secondary outcome
Attitudes, behaviors, and cultural identity assessed at 3-months, 6-months, and 15-months following treatment initiation
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 10 Sep 2007.
Related trials for Domestic Violence
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Self-Dehumanization and Hesitation to Report Domestic Violence
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Community Resiliency Collective Efficacy Intervention
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Enrolling by invitation
Evaluation of a Trauma-Informed Partner Violence Intervention Program
Domestic Violence, Post Traumatic Stress Disorder
Not yet recruiting
Metacognitive Interpersonal Therapy for Male Intimate Partner Violence Perpetrators With Personality Disorders
Intimate Partner Violence, Personality Disorders
RecruitingObservational study
Evaluation of the Impact on Mental and Physical Health of Caring for Women Who Are Victims of Sexual and Gender-based Violence, Using a Coordinated Multidisciplinary Approach in Women's Centres or Traditional Health Centres.
Domestic and/or Sexual Violence
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.
Linda Slutter principal investigator
Turning Point for Families
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ke Ala Lokahi (Native Hawaiian cultural intervention) in people with Domestic Violence, 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 10 Sep 2007. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Subsequent incidents of intimate partner or sexual violence for up to 2 years post-intervention. 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 10 Sep 2007.