Dating ViolenceHRTSNCT03950128
Healthy Relationships Training Study: A Comparison of Interventions to Reduce Dating Violence on College Campuses
A study testing Mindfulness-Based Skills Training (MBST) and Psychoeducational in people with Dating Violence, run by Kent State University at 1 site in United States.
Trial summary
The purpose of this study is to compare the efficacy of a mindfulness-based skills training (MBST) to a psychoeducational intervention at reducing dating violence in a sample of college students. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dating Violence
- What is being tested?
- Mindfulness-Based Skills Training (MBST) and Psychoeducational
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2018to 2 Dec 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In a current dating relationship (of 6 months or longer)
Who cannot join
- Diagnosed with psychopathology (Major Depressive Disorder, Post-Traumatic Stress Disorder, Borderline Personality Disorder)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Healthy Relationships Training Study: Comparing the Efficacy of a Mindfulness-Based Skills Training to a Psychoeducational Intervention at Reducing Dating Violence on College Campuses
The purpose of this study is to compare the efficacy of a mindfulness-based skills training (MBST) to a psychoeducational intervention at reducing dating violence in a sample of college students. The MBST focuses on improving college students' abilities to manage emotionally charged states during conflict with their romantic partners by teaching them mindfulness-based skills. The psychoeducational intervention uses the Love is Not Abuse curriculum. Treatment groups are randomly assigned and are compared using a two-armed parallel design.
88 college students currently in a dating relationship were recruited through Kent State University's subject pool. All participants completed a baseline assessment online where self-reported data was collected on demographics, dating violence (during the past month), emotion regulation, mindfulness skills, and other potential covariates. Participants were then randomized into either the MBST intervention or the psychoeducational intervention. All participants completed three 50-minute sessions over the course of three weeks with assigned homework between sessions. Daily diary data was collected, assessing knowledge and use of skills learned in the sessions. Follow-up data was collected online 11 weeks following baseline (dating violence (during the last month), emotion regulation, mindfulness skills).
It was hypothesized that the MBST intervention would be more effective at reducing dating violence as compared to the psychoeducational intervention.
- Conditions
- Dating Violence
- Being tested
- Mindfulness-Based Skills Training (MBST), Psychoeducational
- Keywords
- Dating aggression, Emotion regulation, Mindfulness, Mindfulness-based skills, Romantic relationships, Dating relationships
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Skills Training (MBST)Behavioural
This intervention teaches students mindfulness-based skills to help manage their emotions when resolving conflict with their partners. The skills followed the "ABCDE" acronym. ABCDE stands for awareness, breathing, checking in with your feelings and thoughts, describing your experience, and expressing what you want to change. Students learned about the skills and had opportunities to practice them as well.
PsychoeducationalBehavioural
This intervention is based on the Love is Not Abuse (LINA) Curriculum (Liz Claiborne Education Development Center (n.d.)). It was adapted to be given over the course of three 50-minute sessions. The selected materials covered (a) what dating abuse is, (b) the pattern of abuse and, (c) technology and dating abuse. The curriculum is interactive and includes handouts, activities, and discussion.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Skills Training | Experimental | This intervention teaches students mindfulness-based skills to help manage their emotions when resolving conflict with their partners. The intervention is given over the course of three 50-minute sessions with homework between sessions. Receives: Behavioral: Mindfulness-Based Skills Training (MBST) |
| Psychoeducational | Active comparator | This intervention is based on the Love is Not Abuse (LINA) Curriculum (Liz Claiborne Education Development Center (n.d.)). It was adapted to be given over the course of three 50-minute sessions. Receives: Behavioral: Psychoeducational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Conflict in Adolescent Dating Relationships Inventory (CADR; Wolfe et al., 2001)
A 35-item self-report measure of physical, verbal, and sexual dating violence.
Measured: Baseline (4th week of semester) and Follow-up (11 weeks after baseline)
Secondary outcomes (3)
Kentucky Inventory of Mindfulness Skills (KIMS; Baer, Smith, & Allen, 2004)
This self-report measure has a total of 39 items with four subscales that assess: observing (e.g., I notice when my moods begin to change), describing (e.g., I'm good at finding the words to describe my feelings), accepting without judgment (e.g., I criticize myself for having irrational or inappropriate emotions [reverse scored]), and acting with awareness (e.g., When I'm doing something, I'm only focused on what I'm doing, nothing else).
Measured: Baseline (4th week of semester) and Follow-up (11 weeks after baseline)
The Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)
This self-report measure asks participants to indicate how often a series of items applies to them (36 items total), rated on a 5-point scale (1 = almost never, 2 = sometimes, 3 = about half of the time, 4 = most of the time, 5 = almost always). The six subscales are: lack of emotional awareness (e.g., "When I'm upset, I take time to figure out what I'm really feeling" [reverse scored]), lack of emotional clarity (e.g., "I have difficulty making sense out of my feelings"), nonacceptance of emotional responses (e.g., "When I'm upset, I become angry with myself for feeling that way"), impulse control difficulties (e.g., "When I'm upset, I lose control over my behaviors"), limited access to emotion regulation strategies (e.g., "When I'm upset, believe that wallowing in it is all I can do"), and difficulties engaging in goal-directed behavior (e.g., "When I'm upset, I have difficulty thinking about anything else").
Measured: Baseline (4th week of semester) and Follow-up (11 weeks after baseline)
3. Intimate Partner Violence Attitudes Scale-Revised (IPVAS-R; Fincham, Cui, Braithwaite, & Pasley, 2008)
This self-report measure asks participants to indicate how strongly they agree or disagree with a series of 17 statements on a five-point Likert scale (1 = Strongly disagree, 5 = Strongly agree). There are three subscales: abuse (e.g., "During a heated argument, it is okay for me to bring up something from my partner's past to hurt him or her"), control (e.g., "It is okay for me to tell my partner not to talk to someone of the opposite sex"), and violence (e.g., "It would never be appropriate to hit or try to hit one's partner with an object" [reverse scored]).
Measured: Baseline (4th week of semester) and Follow-up (11 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start5 Feb 2018
- Primary completion2 Dec 2018
- Study completion2 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dating 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kent State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manfred van Dulmen, Kent State University
- Investigators
- Manfred van Dulmen, PhD, Principal investigator, Kent State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950128
- Sponsor's protocol ID
- 17-547
- Acronym
- HRTS
- Status last verified
- May 2019
- First submitted
- 9 May 2019
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The PI and co-PI are the only researchers involved in the project. Thus, no plans for sharing are necessary.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Relationships Training Study: Comparing the Efficacy of a Mindfulness-Based Skills Training to a Psychoeducational Intervention at Reducing Dating Violence on College Campuses
- ClinicalTrials.gov ID
- NCT03950128
- Acronym / sponsor ID
- HRTS / 17-547
- Conditions
- Dating Violence
- Keywords
- Dating aggression, Emotion regulation, Mindfulness, Mindfulness-based skills, Romantic relationships, Dating relationships
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Kent State UniversityUniversity, hospital or other
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 2 Dec 2018 (actual)
- Study completion
- 2 Dec 2018 (actual)
- First posted
- 15 May 2019 (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 purpose of this study is to compare the efficacy of a mindfulness-based skills training (MBST) to a psychoeducational intervention at reducing dating violence in a sample of college students. The MBST focuses on improving college students' abilities to manage emotionally charged states during conflict with their romantic partners by teaching them mindfulness-based skills. The psychoeducational intervention uses the Love is Not Abuse curriculum. Treatment groups are randomly assigned and are compared using a two-armed parallel design.
88 college students currently in a dating relationship were recruited through Kent State University's subject pool. All participants completed a baseline assessment online where self-reported data was collected on demographics, dating violence (during the past month), emotion regulation, mindfulness skills, and other potential covariates. Participants were then randomized into either the MBST intervention or the psychoeducational intervention. All participants completed three 50-minute sessions over the course of three weeks with assigned homework between sessions. Daily diary data was collected, assessing knowledge and use of skills learned in the sessions. Follow-up data was collected online 11 weeks following baseline (dating violence (during the last month), emotion regulation, mindfulness skills).
It was hypothesized that the MBST intervention would be more effective at reducing dating violence as compared to the psychoeducational intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Skills Training | Experimental | Behavioral: Mindfulness-Based Skills Training (MBST)This intervention teaches students mindfulness-based skills to help manage their emotions when resolving conflict with their partners. The intervention is given over the course of three 50-minute sessions with homework between sessions. |
| Psychoeducational | Active comparator | Behavioral: PsychoeducationalThis intervention is based on the Love is Not Abuse (LINA) Curriculum (Liz Claiborne Education Development Center (n.d.)). It was adapted to be given over the course of three 50-minute sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- In a current dating relationship (of 6 months or longer)
Key exclusion criteria (1 listed)
- Diagnosed with psychopathology (Major Depressive Disorder, Post-Traumatic Stress Disorder, Borderline Personality Disorder)
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 |
|---|---|---|
| Mindfulness-Based Skills Training (MBST)This intervention teaches students mindfulness-based skills to help manage their emotions when resolving conflict with their partners. The skills followed the "ABCDE" acronym. ABCDE stands for awareness, breathing, checking in with your feelings and thoughts, describing your experience, and expressing what you want to change. Students learned about the skills and had opportunities to practice them as well. | Behavioural | Mindfulness-Based Skills Training |
| PsychoeducationalThis intervention is based on the Love is Not Abuse (LINA) Curriculum (Liz Claiborne Education Development Center (n.d.)). It was adapted to be given over the course of three 50-minute sessions. The selected materials covered (a) what dating abuse is, (b) the pattern of abuse and, (c) technology and dating abuse. The curriculum is interactive and includes handouts, activities, and discussion. | Behavioural | Psychoeducational |
Primary outcome
Change in Conflict in Adolescent Dating Relationships Inventory (CADR; Wolfe et al., 2001)
Time frame: Baseline (4th week of semester) and Follow-up (11 weeks after baseline)
A 35-item self-report measure of physical, verbal, and sexual dating violence.
3 secondary outcomes
Kentucky Inventory of Mindfulness Skills (KIMS; Baer, Smith, & Allen, 2004)
Time frame: Baseline (4th week of semester) and Follow-up (11 weeks after baseline)
The Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)
Time frame: Baseline (4th week of semester) and Follow-up (11 weeks after baseline)
3. Intimate Partner Violence Attitudes Scale-Revised (IPVAS-R; Fincham, Cui, Braithwaite, & Pasley, 2008)
Time frame: Baseline (4th week of semester) and Follow-up (11 weeks after baseline)
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 15 May 2019.
- Individual participant dataSharing planned: No. The PI and co-PI are the only researchers involved in the project. Thus, no plans for sharing are necessary.
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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.
Manfred van Dulmen, PhD principal investigator
Kent State 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 Mindfulness-Based Skills Training (MBST) and Psychoeducational in people with Dating Violence, run by Kent State 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 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 15 May 2019. 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?
Change in Conflict in Adolescent Dating Relationships Inventory (CADR; Wolfe et al., 2001) (time frame: Baseline (4th week of semester) and Follow-up (11 weeks after baseline)). 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 15 May 2019.