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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04517994
Other study ID # CDMRP-PT140092
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2015
Est. completion date September 30, 2021

Study information

Verified date April 2022
Source Boston VA Research Institute, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date September 30, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Will be excluded on the basis of reading difficulties that preclude valid completion of the assessment instruments

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Active Treatment
See arm description.
Supportive Treatment
See arm description.

Locations

Country Name City State
United States Joint Base Lewis McChord Tacoma Washington

Sponsors (2)

Lead Sponsor Collaborator
Boston VA Research Institute, Inc. United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Intake/Pre-Treatment
Primary 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. Post-treatment (after 10 weeks of class)
Primary 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. 3-month post-group follow-up (3-months after last class)
Primary 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. Intake/Pre-Treatment
Primary 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. Post-treatment (after 10 weeks of class)
Primary 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. 3-month post-group follow-up (3-months after last class)
Primary 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. Intake/Pre-Treatment
Primary 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. Post-treatment (after 10 weeks of class)
Primary 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. 3-month post-group follow-up (3-months after last class)
Secondary 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. Intake/Pre-Treatment
Secondary 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. Post-treatment (after 10 weeks of class)
Secondary 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. 3-month post-group follow-up (3-months after last class)
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