Intimate Partner ViolenceNCT04517994
Implementation of Strength at Home for Military Couples
A study testing Active Treatment and Supportive Treatment in people with Intimate Partner Violence, run by Boston VA Research Institute, Inc. at 1 site in United States.
Trial summary
The Strength at Home Couples program is designed to enhance intimate relationships and prevent intimate partner violence (IPV) among service members and their partners in light of the unique stressors and experiences of this population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intimate Partner Violence
- What is being tested?
- Active Treatment and Supportive Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2015to 30 Sep 2021
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Couples must be in an intimate relationship
- Must be over the age of 18
- Both members of the couple report no occurrence of physical IPA in the past 3 months and no severe aggression in the past 12
- At least one member reports at or below a score of 100 on the Dyadic Adjustment Scale
- Both members must provide research consent
Who cannot join
- Will be excluded on the basis of reading difficulties that preclude valid completion of the assessment instruments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Strength at Home Couples Program to Prevent Military Partner Violence
The Strength at Home Couples program is designed to enhance intimate relationships and prevent intimate partner violence (IPV) among service members and their partners in light of the unique stressors and experiences of this population.
Read the detailed description
A Hybrid Type-I Implementation-effectiveness research design will allow the research team, comprising investigators with expertise in treatment development, efficacy and effectiveness research, and implementation science, to simultaneously investigate the effectiveness of SAH-C in a military population while identifying any barriers to implementation that would need to be addressed before SAH-C could be successfully implemented on a larger scale.
SAH-C derives from a unique fusion of interventions for trauma and IPA, integrating elements of cognitive processing therapy for PTSD,39 couples therapy for PTSD,40 and a cognitive behavioral intervention for IPA.41 SAH-C consists of 10 two-hour weekly sessions, co-led by two therapists. This was the minimum length deemed necessary to incorporate components addressing the proposed IPA mechanisms and is consistent with the briefest IPA interventions.42 During each session, couples are provided assignments to practice skills together and to assist with the consolidation of material. A group couples format is used because group cohesion among clients appears to be associated with IPA prevention.43 Group interventions also use less time and resources than individual-based interventions.
- Conditions
- Intimate Partner Violence
- Being tested
- Active Treatment, Supportive Treatment
- Keywords
- Prevention, Domestic Violence, Military Couples, Veterans, Marital Relationship, Trauma, PTSD, Implementation
- Medical subject headings
- Wounds and Injuries, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active TreatmentBehavioural
See arm description.
Supportive TreatmentBehavioural
See arm description.
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Experimental | The intervention includes components from empirically validated interventions for intimate relationship difficulties and PTSD. This includes core themes of trust, self-esteem, power and control, conflict-management skills, and communication skills training. Receives: Behavioral: Active Treatment |
| Supportive Treatment | Active comparator | Broadly based on the principles and techniques of client centered (Rogerian) therapy, and the fundamental principles and practices for experiential group psychotherapy as specified by Yalom. The group also draws upon the work of Murphy's Supportive Therapy protocol specifically for group intervention with domestic abuse perpetrators. Receives: Behavioral: Supportive Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Domestic Violence Prevention - Revised Conflict Tactics Scale (CTS2)
Changes of physical and psychological IPV as evidenced by change in CTS2 responses. Each item response option ranges in value from 0-7 with 0 being the minimum value and 7 being the maximum value. Scale is a 78-item measure with higher scores meaning greater conflict.
Measured: Intake/Pre-Treatment
Domestic Violence Prevention - Change in CTS2
Changes of physical and psychological IPV as evidenced by change in CTS2 responses. Each item response option ranges in value from 0-7 with 0 being the minimum value and 7 being the maximum value. Scale is a 78-item measure with higher scores meaning greater conflict.
Measured: Post-treatment (after 10 weeks of class)
Domestic Violence Prevention - Change in CTS2
Changes of physical and psychological IPV as evidenced by change in CTS2 responses. Each item response option ranges in value from 0-7 with 0 being the minimum value and 7 being the maximum value. Scale is a 78-item measure with higher scores meaning greater conflict.
Measured: 3-month post-group follow-up (3-months after last class)
Relationship Satisfaction: Dyadic Adjustment Scale
Changes in relationship satisfaction as evidenced by answers to the Dyadic Adjustment Scale. Items 1-15 options: Always Agree, Almost Always Agree, Occasionally Disagree, Frequently Disagree, Almost Always Disagree, Always Disagree. Item 16-22: All the Time, Most of the Time, More Often than Not, Rarely, Never. Item 23: Every day, Almost Every Day, Occasionally, Rarely, Never. Item 24: All of them, Most of them, Some of them, Very few of them, None of them. Items 25-28: Never, Less than once a month, Once or twice a month, Once or twice a week, Once a day, More often. Items 29-30: Yes/No. Item 31: Extremely Unhappy, Fairly Unhappy, A Little Unhappy, Happy, Very Happy, Extremely Happy, Perfect. Item 32: six statements in which the participant picks the statement that best describes how they feel about the future of their relationship. Overall score ranges from 0 to 151; higher scores indicating a more positive adjustment and lower level of distress within relationship.
Measured: Intake/Pre-Treatment
Change in Relationship Satisfaction: Dyadic Adjustment Scale
Changes in relationship satisfaction as evidenced by answers to the Dyadic Adjustment Scale. Items 1-15 options: Always Agree, Almost Always Agree, Occasionally Disagree, Frequently Disagree, Almost Always Disagree, Always Disagree. Item 16-22: All the Time, Most of the Time, More Often than Not, Rarely, Never. Item 23: Every day, Almost Every Day, Occasionally, Rarely, Never. Item 24: All of them, Most of them, Some of them, Very few of them, None of them. Items 25-28: Never, Less than once a month, Once or twice a month, Once or twice a week, Once a day, More often. Items 29-30: Yes/No. Item 31: Extremely Unhappy, Fairly Unhappy, A Little Unhappy, Happy, Very Happy, Extremely Happy, Perfect. Item 32: six statements in which the participant picks the statement that best describes how they feel about the future of their relationship. Overall score ranges from 0 to 151; higher scores indicating a more positive adjustment and lower level of distress within relationship.
Measured: Post-treatment (after 10 weeks of class)
Change in Relationship Satisfaction: Dyadic Adjustment Scale
Changes in relationship satisfaction as evidenced by answers to the Dyadic Adjustment Scale. Items 1-15 options: Always Agree, Almost Always Agree, Occasionally Disagree, Frequently Disagree, Almost Always Disagree, Always Disagree. Item 16-22: All the Time, Most of the Time, More Often than Not, Rarely, Never. Item 23: Every day, Almost Every Day, Occasionally, Rarely, Never. Item 24: All of them, Most of them, Some of them, Very few of them, None of them. Items 25-28: Never, Less than once a month, Once or twice a month, Once or twice a week, Once a day, More often. Items 29-30: Yes/No. Item 31: Extremely Unhappy, Fairly Unhappy, A Little Unhappy, Happy, Very Happy, Extremely Happy, Perfect. Item 32: six statements in which the participant picks the statement that best describes how they feel about the future of their relationship. Overall score ranges from 0 to 151; higher scores indicating a more positive adjustment and lower level of distress within relationship.
Measured: 3-month post-group follow-up (3-months after last class)
Domestic Violence Prevention - Multidimensional Measure of Emotional Abuse (MMEA)
Changes of physical and psychological IPV as evidenced by changes in MMEA scores. MMEA is a 28-item measurement tool with scale responses ranging from 0 to 7 where higher scores indicate greater emotional abuse.
Measured: Intake/Pre-Treatment
Domestic Violence Prevention - Change in MMEA
Changes of physical and psychological IPV as evidenced by changes in MMEA scores. MMEA is a 28-item measurement tool with scale responses ranging from 0 to 7 where higher scores indicate greater emotional abuse.
Measured: Post-treatment (after 10 weeks of class)
Domestic Violence Prevention - Change in MMEA
Changes of physical and psychological IPV as evidenced by changes in MMEA scores. MMEA is a 28-item measurement tool with scale responses ranging from 0 to 7 where higher scores indicate greater emotional abuse.
Measured: 3-month post-group follow-up (3-months after last class)
Secondary outcomes (3)
Suicidal Ideation
Changes in suicidal ideation through the suicidality measure asking about suicidal thoughts (the four response options include: I do not have thoughts, Sometimes I have thoughts, Most of the time I have thoughts, and I always have thoughts), suicide attempts (response is a fill in the blank), wish to live/die (the three response options include I have a moderate to strong wish to live/die, I have a weak wish to live/die, and I have no wish to live/die), and belongingness (some items will be reverse scored and the 7-point Likert scale includes 1[Not at all true for me], 2, 3, 4 [Somewhat true for me], 5, 6, 7 [Very true for me]). Lower scores indicate less suicidal ideation.
Measured: Intake/Pre-Treatment
Suicidal Ideation
Changes in suicidal ideation through the suicidality measure asking about suicidal thoughts (the four response options include: I do not have thoughts, Sometimes I have thoughts, Most of the time I have thoughts, and I always have thoughts), suicide attempts (response is a fill in the blank), wish to live/die (the three response options include I have a moderate to strong wish to live/die, I have a weak wish to live/die, and I have no wish to live/die), and belongingness (some items will be reverse scored and the 7-point Likert scale includes 1[Not at all true for me], 2, 3, 4 [Somewhat true for me], 5, 6, 7 [Very true for me]). Lower scores indicate less suicidal ideation.
Measured: Post-treatment (after 10 weeks of class)
Suicidal Ideation
Changes in suicidal ideation through the suicidality measure asking about suicidal thoughts (the four response options include: I do not have thoughts, Sometimes I have thoughts, Most of the time I have thoughts, and I always have thoughts), suicide attempts (response is a fill in the blank), wish to live/die (the three response options include I have a moderate to strong wish to live/die, I have a weak wish to live/die, and I have no wish to live/die), and belongingness (some items will be reverse scored and the 7-point Likert scale includes 1[Not at all true for me], 2, 3, 4 [Somewhat true for me], 5, 6, 7 [Very true for me]). Lower scores indicate less suicidal ideation.
Measured: 3-month post-group follow-up (3-months after last class)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start1 Sep 2015
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intimate Partner 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston VA Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Casey Taft, VA Boston Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04517994
- Sponsor's protocol ID
- CDMRP-PT140092
- Status last verified
- Apr 2022
- First submitted
- 26 Jan 2018
- Last updated
- 28 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strength at Home Couples Program to Prevent Military Partner Violence
- ClinicalTrials.gov ID
- NCT04517994
- Acronym / sponsor ID
- CDMRP-PT140092
- Conditions
- Intimate Partner Violence
- Keywords
- Prevention, Domestic Violence, Military Couples, Veterans, Marital Relationship, Trauma, PTSD, Implementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Boston VA Research Institute, Inc.University, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 19 Aug 2020 (actual)
- 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 Strength at Home Couples program is designed to enhance intimate relationships and prevent intimate partner violence (IPV) among service members and their partners in light of the unique stressors and experiences of this population.
Detailed description
A Hybrid Type-I Implementation-effectiveness research design will allow the research team, comprising investigators with expertise in treatment development, efficacy and effectiveness research, and implementation science, to simultaneously investigate the effectiveness of SAH-C in a military population while identifying any barriers to implementation that would need to be addressed before SAH-C could be successfully implemented on a larger scale.
SAH-C derives from a unique fusion of interventions for trauma and IPA, integrating elements of cognitive processing therapy for PTSD,39 couples therapy for PTSD,40 and a cognitive behavioral intervention for IPA.41 SAH-C consists of 10 two-hour weekly sessions, co-led by two therapists. This was the minimum length deemed necessary to incorporate components addressing the proposed IPA mechanisms and is consistent with the briefest IPA interventions.42 During each session, couples are provided assignments to practice skills together and to assist with the consolidation of material. A group couples format is used because group cohesion among clients appears to be associated with IPA prevention.43 Group interventions also use less time and resources than individual-based interventions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Experimental | Behavioral: Active TreatmentThe intervention includes components from empirically validated interventions for intimate relationship difficulties and PTSD. This includes core themes of trust, self-esteem, power and control, conflict-management skills, and communication skills training. |
| Supportive Treatment | Active comparator | Behavioral: Supportive TreatmentBroadly based on the principles and techniques of client centered (Rogerian) therapy, and the fundamental principles and practices for experiential group psychotherapy as specified by Yalom. The group also draws upon the work of Murphy's Supportive Therapy protocol specifically for group intervention with domestic abuse perpetrators. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Couples must be in an intimate relationship
- Must be over the age of 18
- Both members of the couple report no occurrence of physical IPA in the past 3 months and no severe aggression in the past 12
- At least one member reports at or below a score of 100 on the Dyadic Adjustment Scale
- Both members must provide research consent
Key exclusion criteria (1 listed)
- Will be excluded on the basis of reading difficulties that preclude valid completion of the assessment instruments
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 |
|---|---|---|
| Active TreatmentSee arm description. | Behavioural | Active Treatment |
| Supportive TreatmentSee arm description. | Behavioural | Supportive Treatment |
Primary outcome
Domestic Violence Prevention - Revised Conflict Tactics Scale (CTS2)
Time frame: Intake/Pre-Treatment
Changes of physical and psychological IPV as evidenced by change in CTS2 responses. Each item response option ranges in value from 0-7 with 0 being the minimum value and 7 being the maximum value. Scale is a 78-item measure with higher scores meaning greater conflict.
Domestic Violence Prevention - Change in CTS2
Time frame: Post-treatment (after 10 weeks of class)
Changes of physical and psychological IPV as evidenced by change in CTS2 responses. Each item response option ranges in value from 0-7 with 0 being the minimum value and 7 being the maximum value. Scale is a 78-item measure with higher scores meaning greater conflict.
Domestic Violence Prevention - Change in CTS2
Time frame: 3-month post-group follow-up (3-months after last class)
Changes of physical and psychological IPV as evidenced by change in CTS2 responses. Each item response option ranges in value from 0-7 with 0 being the minimum value and 7 being the maximum value. Scale is a 78-item measure with higher scores meaning greater conflict.
Relationship Satisfaction: Dyadic Adjustment Scale
Time frame: Intake/Pre-Treatment
Changes in relationship satisfaction as evidenced by answers to the Dyadic Adjustment Scale. Items 1-15 options: Always Agree, Almost Always Agree, Occasionally Disagree, Frequently Disagree, Almost Always Disagree, Always Disagree. Item 16-22: All the Time, Most of the Time, More Often than Not, Rarely, Never. Item 23: Every day, Almost Every Day, Occasionally, Rarely, Never. Item 24: All of them, Most of them, Some of them, Very few of them, None of them. Items 25-28: Never, Less than once a month, Once or twice a month, Once or twice a week, Once a day, More often. Items 29-30: Yes/No. Item 31: Extremely Unhappy, Fairly Unhappy, A Little Unhappy, Happy, Very Happy, Extremely Happy, Perfect. Item 32: six statements in which the participant picks the statement that best describes how they feel about the future of their relationship. Overall score ranges from 0 to 151; higher scores indicating a more positive adjustment and lower level of distress within relationship.
Change in Relationship Satisfaction: Dyadic Adjustment Scale
Time frame: Post-treatment (after 10 weeks of class)
Changes in relationship satisfaction as evidenced by answers to the Dyadic Adjustment Scale. Items 1-15 options: Always Agree, Almost Always Agree, Occasionally Disagree, Frequently Disagree, Almost Always Disagree, Always Disagree. Item 16-22: All the Time, Most of the Time, More Often than Not, Rarely, Never. Item 23: Every day, Almost Every Day, Occasionally, Rarely, Never. Item 24: All of them, Most of them, Some of them, Very few of them, None of them. Items 25-28: Never, Less than once a month, Once or twice a month, Once or twice a week, Once a day, More often. Items 29-30: Yes/No. Item 31: Extremely Unhappy, Fairly Unhappy, A Little Unhappy, Happy, Very Happy, Extremely Happy, Perfect. Item 32: six statements in which the participant picks the statement that best describes how they feel about the future of their relationship. Overall score ranges from 0 to 151; higher scores indicating a more positive adjustment and lower level of distress within relationship.
Change in Relationship Satisfaction: Dyadic Adjustment Scale
Time frame: 3-month post-group follow-up (3-months after last class)
Changes in relationship satisfaction as evidenced by answers to the Dyadic Adjustment Scale. Items 1-15 options: Always Agree, Almost Always Agree, Occasionally Disagree, Frequently Disagree, Almost Always Disagree, Always Disagree. Item 16-22: All the Time, Most of the Time, More Often than Not, Rarely, Never. Item 23: Every day, Almost Every Day, Occasionally, Rarely, Never. Item 24: All of them, Most of them, Some of them, Very few of them, None of them. Items 25-28: Never, Less than once a month, Once or twice a month, Once or twice a week, Once a day, More often. Items 29-30: Yes/No. Item 31: Extremely Unhappy, Fairly Unhappy, A Little Unhappy, Happy, Very Happy, Extremely Happy, Perfect. Item 32: six statements in which the participant picks the statement that best describes how they feel about the future of their relationship. Overall score ranges from 0 to 151; higher scores indicating a more positive adjustment and lower level of distress within relationship.
Domestic Violence Prevention - Multidimensional Measure of Emotional Abuse (MMEA)
Time frame: Intake/Pre-Treatment
Changes of physical and psychological IPV as evidenced by changes in MMEA scores. MMEA is a 28-item measurement tool with scale responses ranging from 0 to 7 where higher scores indicate greater emotional abuse.
Domestic Violence Prevention - Change in MMEA
Time frame: Post-treatment (after 10 weeks of class)
Changes of physical and psychological IPV as evidenced by changes in MMEA scores. MMEA is a 28-item measurement tool with scale responses ranging from 0 to 7 where higher scores indicate greater emotional abuse.
Domestic Violence Prevention - Change in MMEA
Time frame: 3-month post-group follow-up (3-months after last class)
Changes of physical and psychological IPV as evidenced by changes in MMEA scores. MMEA is a 28-item measurement tool with scale responses ranging from 0 to 7 where higher scores indicate greater emotional abuse.
3 secondary outcomes
Suicidal Ideation
Time frame: Intake/Pre-Treatment
Suicidal Ideation
Time frame: Post-treatment (after 10 weeks of class)
Suicidal Ideation
Time frame: 3-month post-group follow-up (3-months after last class)
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 28 Apr 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Treatment and Supportive Treatment in people with Intimate Partner Violence, run by Boston VA Research Institute, Inc. 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 5 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 28 Apr 2022. 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?
Domestic Violence Prevention - Revised Conflict Tactics Scale (CTS2) (time frame: Intake/Pre-Treatment). The study lists 9 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 28 Apr 2022.