Self-efficacyISISNCT01410669
Motivational Interviewing Intervention for Intimate Partner Violence
A study testing Motivational interviewing (MI) in people with Self-efficacy, run by University of Iowa at 1 site in United States.
Trial summary
This project is a randomized trial to determine if motivational interviewing (MI) is an effective intervention to help women in abusive intimate relationships. The study objective is to motivate abused women to identify and achieve their own specific goals that can help them address the violence in their lives. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Self-efficacy
- What is being tested?
- Motivational interviewing (MI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 305 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Dec 2010
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Screens positive for IPV
- Literate in either English or Spanish
Who cannot join
- Less than 18 years of age
- pregnant at time of screening and consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Motivational Interviewing an Effective Intervention for Women Coping With Intimate Partner Violence
This project is a randomized trial to determine if motivational interviewing (MI) is an effective intervention to help women in abusive intimate relationships. The study objective is to motivate abused women to identify and achieve their own specific goals that can help them address the violence in their lives. This project will be integrated into the setting of a busy family planning clinic in the mid-western United States, which serves a largely rural population. Intimate partner violence (IPV) is screened using the Women's Experience with Battering Scale (WEB), a modified Abuse Assessment Screen (AAS), and the Danger Assessment Screen (DAS). An expected 250 women who screen positive for IPV will be enrolled, randomized to the intervention or to usual care group, and complete the 6-month study protocol. All subjects complete a self-administered computer-based questionnaire at the initial and 6-month follow up visits to measure self-efficacy (primary outcome), stage of readiness to change, selected IPV-related health correlates (e.g., depression), and steps taken and resources used. The MI intervention is an "active listening" counseling technique aimed at guiding the patient towards identifying feasible, personalized goals and steps she can take to increase her self-efficacy and control in the relationship. The trained study interviewer will work with participants to identify steps they can safely take and local resources to help them meet their goals. The MI protocol consists of a face-to-face counseling session at baseline with follow-up telephone interviews conducted at 1-, 2-, and 4-months post-intervention to reinforce the intervention and assess the participants' level safety. The control group will receive usual care, which includes talking with a Level 3 Domestic Violence Advocate and receiving a comprehensive list of domestic violence resources. Effectiveness of the MI intervention will be determined by increased self-efficacy, measured by the Domestic Violence Coping and Self-Efficacy Scale, a validated tool for use among women with a recent history of domestic abuse; and by a reduction in depressive symptoms (CESD-10). The impact of the intervention will be assessed by an increase in participants' readiness-to-change, and extent of their involvement in a wide variety of self-help and coping activities over the follow-up period. If successful, this screening and intervention program will be translated to other clinical settings.
- Conditions
- Self-efficacy
- Being tested
- Motivational interviewing (MI)
- Keywords
- Self-efficacy, Intimate partner violence, Randomized clinical trial, Depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewing (MI)Behavioural
MI is a "client-centered" counseling approach developed to deliver stage-tailored intervention messages using non-confrontational, supportive communication strategies. The client is encouraged to explore the barriers and facilitating factors associated with the behavior change. The interviewer's role is to guide the conversation and avoid use of conventional directive approaches (e.g., persuasion, providing information).
In this trial, a trained motivational interviewer meets individually with patients randomized to the intervention for one-hour at baseline, followed by four MI telephone follow up contacts at 1-, 2-, and 4-months post baseline.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing (MI) | Experimental | Not described Receives: Behavioral: Motivational interviewing (MI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-efficacy
The Domestic Violence Coping Self-efficacy Measure by Benight et al (2004) was modified to measure self efficacy at baseline and 6-months post randomization
Measured: Change from Baseline in Self efficacy at 6 months
Secondary outcomes (1)
Depression
Depression at baseline and 6-month follow-up was measured using the 10 item Center for Epidemiologic Studies Depression Scale (CES-D )
Measured: Change from Baseline in depression at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2011 (estimated)
- Study startDec 2007
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Self-efficacyStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Investigators
- Audrey F Saftlas, PhD, Principal investigator, University of IowaCorinne Peek-Asa, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01410669
- Sponsor's protocol ID
- 5R49CE000924-03
- Acronym
- ISIS
- Status last verified
- Aug 2011
- First submitted
- 1 Aug 2011
- Last updated
- 5 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hameed M, O'Doherty L, Gilchrist G, Tirado-Munoz J, Taft A, Chondros P, Feder G, Tan M, Hegarty K. Psychological therapies for women who experience intimate partner violence. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013017. doi: 10.1002/14651858.CD013017.pub2.
PubMed 32608505
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Motivational Interviewing an Effective Intervention for Women Coping With Intimate Partner Violence
- ClinicalTrials.gov ID
- NCT01410669
- Acronym / sponsor ID
- ISIS / 5R49CE000924-03
- Conditions
- Self-efficacy
- Keywords
- Self-efficacy, Intimate partner violence, Randomized clinical trial, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 5 Aug 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.
This project is a randomized trial to determine if motivational interviewing (MI) is an effective intervention to help women in abusive intimate relationships. The study objective is to motivate abused women to identify and achieve their own specific goals that can help them address the violence in their lives. This project will be integrated into the setting of a busy family planning clinic in the mid-western United States, which serves a largely rural population. Intimate partner violence (IPV) is screened using the Women's Experience with Battering Scale (WEB), a modified Abuse Assessment Screen (AAS), and the Danger Assessment Screen (DAS). An expected 250 women who screen positive for IPV will be enrolled, randomized to the intervention or to usual care group, and complete the 6-month study protocol. All subjects complete a self-administered computer-based questionnaire at the initial and 6-month follow up visits to measure self-efficacy (primary outcome), stage of readiness to change, selected IPV-related health correlates (e.g., depression), and steps taken and resources used. The MI intervention is an "active listening" counseling technique aimed at guiding the patient towards identifying feasible, personalized goals and steps she can take to increase her self-efficacy and control in the relationship. The trained study interviewer will work with participants to identify steps they can safely take and local resources to help them meet their goals. The MI protocol consists of a face-to-face counseling session at baseline with follow-up telephone interviews conducted at 1-, 2-, and 4-months post-intervention to reinforce the intervention and assess the participants' level safety. The control group will receive usual care, which includes talking with a Level 3 Domestic Violence Advocate and receiving a comprehensive list of domestic violence resources. Effectiveness of the MI intervention will be determined by increased self-efficacy, measured by the Domestic Violence Coping and Self-Efficacy Scale, a validated tool for use among women with a recent history of domestic abuse; and by a reduction in depressive symptoms (CESD-10). The impact of the intervention will be assessed by an increase in participants' readiness-to-change, and extent of their involvement in a wide variety of self-help and coping activities over the follow-up period. If successful, this screening and intervention program will be translated to other clinical settings.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing (MI) | Experimental | Behavioral: Motivational interviewing (MI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Screens positive for IPV
- Literate in either English or Spanish
Key exclusion criteria (2 listed)
- Less than 18 years of age
- pregnant at time of screening and consent
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 |
|---|---|---|
| Motivational interviewing (MI)MI is a "client-centered" counseling approach developed to deliver stage-tailored intervention messages using non-confrontational, supportive communication strategies. The client is encouraged to explore the barriers and facilitating factors associated with the behavior change. The interviewer's role is to guide the conversation and avoid use of conventional directive approaches (e.g., persuasion, providing information). In this trial, a trained motivational interviewer meets individually with patients randomized to the intervention for one-hour at baseline, followed by four MI telephone follow up contacts at 1-, 2-, and 4-months post baseline. | Behavioural | Motivational Interviewing (MI) |
Primary outcome
Self-efficacy
Time frame: Change from Baseline in Self efficacy at 6 months
The Domestic Violence Coping Self-efficacy Measure by Benight et al (2004) was modified to measure self efficacy at baseline and 6-months post randomization
1 secondary outcome
Depression
Time frame: Change from Baseline in depression at 6 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 5 Aug 2011.
- Derived from this study: PubMed 32608505Hameed M, O'Doherty L, Gilchrist G, Tirado-Munoz J, Taft A, Chondros P, Feder G, Tan M, Hegarty K. Psychological therapies for women who experience intimate partner violence. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013017. doi: 10.1002/14651858.CD013017.pub2.
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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.
Audrey F Saftlas, PhD principal investigator
University of Iowa
Corinne Peek-Asa, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interviewing (MI) in people with Self-efficacy, run by University of Iowa 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 3 inclusion and 2 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 5 Aug 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.
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?
Self-efficacy (time frame: Change from Baseline in Self efficacy at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01410669, which also lists 1 linked publication.
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 5 Aug 2011.