Adverse Childhood ExperiencesACENCT03836456
Approaches That Support Mental Health in Post-secondary Students With Adverse Childhood Experiences
A study testing Mindfulness-based Stress Resilience Training and Health Enhancement Program in people with Adverse Childhood Experiences and Mindfulness, run by Dalhousie University at 1 site in Canada.
Trial summary
The objective of this study is to understand the prevalence of adverse childhood experiences (ACE) in students and to determine whether Mindfulness based stress resilience training (MBSR) is effective for promoting mental health in students with high ACE scores (>3). Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Adverse Childhood Experiences, Mindfulness, Students
- What is being tested?
- Mindfulness-based Stress Resilience Training and Health Enhancement Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2019to 1 Sep 2019
- 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 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Post-secondary education students who are over the age of 18 and who had experienced more than 3 Adverse Childhood Experiences
Who cannot join
- Persons who had received prior training in mindfulness based approaches.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Dalhousie University
Halifax, Nova Scotia, B3H 2Y9
Robert Gilbert, PhD, 9024732791, rob.gilbert@dal.ca
Amy Munroe, BSc, 9024944129, amy.munroe@dal.ca
About this study
Official title: Defining Approaches That Support the Mental Health of Post-secondary Students Who Experienced More Than Three Adverse Childhood Experiences
The objective of this study is to understand the prevalence of adverse childhood experiences (ACE) in students and to determine whether Mindfulness based stress resilience training (MBSR) is effective for promoting mental health in students with high ACE scores (>3). A double-blind randomized control study will examine the efficacy of MBSR in promoting positive change in measures of hope, rumination, forgiveness and stress.
Read the detailed description
The Adverse Childhood Experiences Study examined the physical health and psychosocial consequences of ACE across the lifespan. This study demonstrated adverse childhood experiences (ACE) prevalence to be high and a direct correlation between ACE scores (a tally of different types of abuse, neglect, and household dysfunction experienced under the age of 18) and prevalence of physical health and psychosocial problems in adulthood. Adults with >3 ACE are more likely to experience social underachievement (e.g. lower educational achievement and economic productivity), physical and mental health problems (e.g. depression, heart disease, suicide attempts, substance abuse) and unhealthy lifestyle behaviours (e.g. smoking, physical inactivity). Worldwide, ACE have been shown to be prevalent, independent of social and economic factors, and highly interrelated. 12.5% of subjects reported >4 ACE. Among post-secondary students, studies determined high ACE scores to be associated with higher prevalence of risk behaviours and physical health and psychosocial problems. Failure to support the physical and mental health of students can lead to increased attrition, deterioration of well-being, and intentional self-harm.
Recognition of ACE prevalence and its consequences has been paralleled by the development of interventions for mitigating the lifetime health and social consequences of ACE. A 2016 study examining interventions believed to improve the mental health of adults with significant ACE (>3) identified mindfulness-based therapies (MBT) as being effective. Mindfulness is a form of cognitive training that cultivates self-regulative ability and enhances resilience.
As no Canadian post-secondary institution has comprehensively investigated the prevalence of student ACE, the objective of this study is to understand the prevalence of ACE in students and to determine whether MBT is effective for promoting mental health in students with high ACE scores (>3).
A double-blind randomized control study will examine the efficacy of MBT, specifically Mindfulness-based Stress Resilience Training (MBSR), in promoting positive change in measures of hope, rumination, forgiveness and distress. Interventions that positively effect these measures are known to enhance quality of life. First year students enrolled at Dalhousie University will be recruited. Subjects will complete an ACE questionnaire and those with >3 ACE prior to age 18 will be invited to participate in this study. Students with prior MBT training will be excluded. Subjects will be randomized to one of two groups: MBSR or an established active control (Health Enhancement Program (HEP)). We selected MBSR because it is secular, codified, and the most scientifically studied mindfulness-based intervention to date. Power analyses determined 25 subjects per group is sufficient to detect a significant difference in outcomes across the groups. Interventionists and subjects will be blinded. Students will be led in group based MBSR or HEP for 4 weeks. Prior to and after the 4-week intervention subjects' outcomes will be determined using the: Perceived Stress Scale; Rumination and Reflection Questionnaire; Heartland Forgiveness Scale and; Adult Dispositional Hope Scale.
Development of evidence-based programs that support the identification of ACE in students and identification of interventions that mitigate negative lifetime consequences of ACE outcomes is needed. This pilot study will increase understanding of Canadian student ACE and assess the effectiveness of MBSR as a tool for supporting the mental health of students who have experienced significant ACE.
- Conditions
- Adverse Childhood Experiences, Mindfulness, Students
- Being tested
- Mindfulness-based Stress Resilience Training, Health Enhancement Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based Stress Resilience TrainingBehavioural
Mindfulness is a form of cognitive training that cultivates self-regulative ability and enhances resilience
Health Enhancement ProgramBehavioural
This is a validated active control developed to serve as a control for mindfulness-based studies.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Intervention | Experimental | Mindfulness Based Stress Resilience Training: This approach will be conducted with study participants for 4 weeks. One evening per week. Receives: Behavioral: Mindfulness-based Stress Resilience Training |
| Active Control Intervention | Active comparator | Health Enhancement Program: This is a validated active comparator used in Mindfulness-based training studies. It will be conducted with the participants one evening per week for 4 weeks. Receives: Behavioral: Health Enhancement Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress
Measure of current stress using the Perceived Stress Scale
Measured: Pre and Post intervention (1 week)
Rumination and Reflection
Measured using the Rumination and Reflection Questionnaire
Measured: Pre and post intervention (1 week)
Forgiveness
Measures using the Heartland Forgiveness Scale
Measured: Pre and post intervention (1 week)
Hope
Measured using the Adult Dispositional Hope Scale
Measured: Pre and post intervention (1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start1 Mar 2019 (estimated)
- Primary completion1 May 2019 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Childhood ExperiencesStudies 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
- Model description
- Randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dalhousie University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rob Gilbert, Dalhousie University
- Investigators
- Nancy Ross, PhD, Study director, School of Social Work, Faculty of Health,Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03836456
- Sponsor's protocol ID
- DalhousieU
- Acronym
- ACE
- Status last verified
- Feb 2019
- First submitted
- 7 Feb 2019
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining Approaches That Support the Mental Health of Post-secondary Students Who Experienced More Than Three Adverse Childhood Experiences
- ClinicalTrials.gov ID
- NCT03836456
- Acronym / sponsor ID
- ACE / DalhousieU
- Conditions
- Adverse Childhood Experiences, Mindfulness, Students
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Dalhousie UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (estimated)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 11 Feb 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 objective of this study is to understand the prevalence of adverse childhood experiences (ACE) in students and to determine whether Mindfulness based stress resilience training (MBSR) is effective for promoting mental health in students with high ACE scores (>3). A double-blind randomized control study will examine the efficacy of MBSR in promoting positive change in measures of hope, rumination, forgiveness and stress.
Detailed description
The Adverse Childhood Experiences Study examined the physical health and psychosocial consequences of ACE across the lifespan. This study demonstrated adverse childhood experiences (ACE) prevalence to be high and a direct correlation between ACE scores (a tally of different types of abuse, neglect, and household dysfunction experienced under the age of 18) and prevalence of physical health and psychosocial problems in adulthood. Adults with >3 ACE are more likely to experience social underachievement (e.g. lower educational achievement and economic productivity), physical and mental health problems (e.g. depression, heart disease, suicide attempts, substance abuse) and unhealthy lifestyle behaviours (e.g. smoking, physical inactivity). Worldwide, ACE have been shown to be prevalent, independent of social and economic factors, and highly interrelated. 12.5% of subjects reported >4 ACE. Among post-secondary students, studies determined high ACE scores to be associated with higher prevalence of risk behaviours and physical health and psychosocial problems. Failure to support the physical and mental health of students can lead to increased attrition, deterioration of well-being, and intentional self-harm.
Recognition of ACE prevalence and its consequences has been paralleled by the development of interventions for mitigating the lifetime health and social consequences of ACE. A 2016 study examining interventions believed to improve the mental health of adults with significant ACE (>3) identified mindfulness-based therapies (MBT) as being effective. Mindfulness is a form of cognitive training that cultivates self-regulative ability and enhances resilience.
As no Canadian post-secondary institution has comprehensively investigated the prevalence of student ACE, the objective of this study is to understand the prevalence of ACE in students and to determine whether MBT is effective for promoting mental health in students with high ACE scores (>3).
A double-blind randomized control study will examine the efficacy of MBT, specifically Mindfulness-based Stress Resilience Training (MBSR), in promoting positive change in measures of hope, rumination, forgiveness and distress. Interventions that positively effect these measures are known to enhance quality of life. First year students enrolled at Dalhousie University will be recruited. Subjects will complete an ACE questionnaire and those with >3 ACE prior to age 18 will be invited to participate in this study. Students with prior MBT training will be excluded. Subjects will be randomized to one of two groups: MBSR or an established active control (Health Enhancement Program (HEP)). We selected MBSR because it is secular, codified, and the most scientifically studied mindfulness-based intervention to date. Power analyses determined 25 subjects per group is sufficient to detect a significant difference in outcomes across the groups. Interventionists and subjects will be blinded. Students will be led in group based MBSR or HEP for 4 weeks. Prior to and after the 4-week intervention subjects' outcomes will be determined using the: Perceived Stress Scale; Rumination and Reflection Questionnaire; Heartland Forgiveness Scale and; Adult Dispositional Hope Scale.
Development of evidence-based programs that support the identification of ACE in students and identification of interventions that mitigate negative lifetime consequences of ACE outcomes is needed. This pilot study will increase understanding of Canadian student ACE and assess the effectiveness of MBSR as a tool for supporting the mental health of students who have experienced significant ACE.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Experimental Intervention | Experimental | Behavioral: Mindfulness-based Stress Resilience TrainingMindfulness Based Stress Resilience Training: This approach will be conducted with study participants for 4 weeks. One evening per week. |
| Active Control Intervention | Active comparator | Behavioral: Health Enhancement ProgramHealth Enhancement Program: This is a validated active comparator used in Mindfulness-based training studies. It will be conducted with the participants one evening per week for 4 weeks. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Post-secondary education students who are over the age of 18 and who had experienced more than 3 Adverse Childhood Experiences
Key exclusion criteria (1 listed)
- Persons who had received prior training in mindfulness based approaches.
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 Stress Resilience TrainingMindfulness is a form of cognitive training that cultivates self-regulative ability and enhances resilience | Behavioural | Experimental Intervention |
| Health Enhancement ProgramThis is a validated active control developed to serve as a control for mindfulness-based studies. | Behavioural | Active Control Intervention |
Primary outcome
Stress
Time frame: Pre and Post intervention (1 week)
Measure of current stress using the Perceived Stress Scale
Rumination and Reflection
Time frame: Pre and post intervention (1 week)
Measured using the Rumination and Reflection Questionnaire
Forgiveness
Time frame: Pre and post intervention (1 week)
Measures using the Heartland Forgiveness Scale
Hope
Time frame: Pre and post intervention (1 week)
Measured using the Adult Dispositional Hope Scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
- Individual participant dataSharing planned: No
Related trials for Adverse Childhood Experiences
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
A Pilot Study to Examine the Efficacy of Internet-Delivered Skills Training in Affective and Interpersonal Regulation (i-STAIR) for Individuals With Adverse Childhood Experiences and Subsyndromal Depression
Subthreshold Depression
Active, not recruiting
Resilient Students Training (ReST) : A Pilot RCT
Psychological Wellness
Not yet recruiting
EMI for Reducing Psychological Distress in Young Adults With Multiple ACEs: A RCT Study
Psychological Distress, Adverse Childhood Experience
Not yet recruiting
EMI for Reducing Psychological Distress in Young Adults With Multiple ACEs: A Feasibility Study
Psychological Distress, Adverse Childhood Experience
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.
Nancy Ross, PhD study director
School of Social Work, Faculty of Health,Dalhousie 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 Stress Resilience Training and Health Enhancement Program in people with Adverse Childhood Experiences and Mindfulness, run by Dalhousie University at 1 site in Canada.
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: status not confirmed, as of the sponsor's last update on 11 Feb 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Gilbert, PhD (9024713336, rob.gilbert@dal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress (time frame: Pre and Post intervention (1 week)). The study lists 4 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 11 Feb 2019.