Approaches That Support Mental Health in Post-secondary Students With Adverse Childhood Experiences

NCT03836456 | Unknown DMC

• 1 other identifier: DalhousieU
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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). A double-blind randomized control study will examine the efficacy of MBSR in promoting positive change in measures of hope, rumination, forgiveness and stress.

Conditions

Adverse Childhood Experiences; Mindfulness; Students

Outcome Measures

Primary Outcomes (4)

• Stress

  Measure of current stress using the Perceived Stress Scale

  Pre and Post intervention (1 week)

• Rumination and Reflection

  Measured using the Rumination and Reflection Questionnaire

  Pre and post intervention (1 week)

• Forgiveness

  Measures using the Heartland Forgiveness Scale

  Pre and post intervention (1 week)

• Hope

  Measured using the Adult Dispositional Hope Scale

  Pre and post intervention (1 week)

Study Arms (2)

Experimental Intervention

EXPERIMENTAL

Mindfulness Based Stress Resilience Training: This approach will be conducted with study participants for 4 weeks. One evening per week.

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.

Behavioral: Health Enhancement Program

Interventions

Mindfulness-based Stress Resilience Training BEHAVIORAL

Mindfulness is a form of cognitive training that cultivates self-regulative ability and enhances resilience

Experimental Intervention

Health Enhancement Program BEHAVIORAL

This is a validated active control developed to serve as a control for mindfulness-based studies.

Active Control Intervention

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Post-secondary education students who are over the age of 18 and who had experienced more than 3 Adverse Childhood Experiences

You may not qualify if:

• Persons who had received prior training in mindfulness based approaches.

Sponsors & Collaborators

• Dalhousie University: lead

Study Sites (1)

Dalhousie University

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Study Officials

• Nancy Ross, PhD

  School of Social Work, Faculty of Health,Dalhousie University

  STUDY DIRECTOR

Central Study Contacts

Robert Gilbert, PhD

CONTACT

9024713336; rob.gilbert@dal.ca

Amy Munroe, BSc

CONTACT

9024944129; amy.munroe@dal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Data collected will be coded and codes will not be revealed to the investigators or outcome assessors until after data analysis is complete. The study participants will be told they are participating in an intervention to promote mental health but not told which of the 2 interventions is the active control.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: February 11, 2019
• Study Start: March 1, 2019
• Primary Completion: May 1, 2019
• Study Completion: September 1, 2019
• Last Updated: February 11, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)