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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
What is being tested?
Mindfulness-based Stress Resilience Training and Health Enhancement Program
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.

Robert Gilbert, PhD contact

9024713336

rob.gilbert@dal.ca

Amy Munroe, BSc contact

9024944129

amy.munroe@dal.ca

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

Other trials in Canada

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.

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 groups in NCT03836456
Study groupRoleWhat they receive
Experimental InterventionExperimentalMindfulness 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 InterventionActive comparatorHealth 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.

  1. Stress

    Measure of current stress using the Perceived Stress Scale

    Measured: Pre and Post intervention (1 week)

  2. Rumination and Reflection

    Measured using the Rumination and Reflection Questionnaire

    Measured: Pre and post intervention (1 week)

  3. Forgiveness

    Measures using the Heartland Forgiveness Scale

    Measured: Pre and post intervention (1 week)

  4. 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.

  1. First posted11 Feb 2019
  2. Study start1 Mar 2019 (estimated)
  3. Primary completion1 May 2019 (estimated)
  4. Study completion1 Sep 2019 (estimated)

Resources

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)
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

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.

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