NCT05619458

Brief Summary

The main goal of this single-arm pre-post intervention study is to see if an adapted mindfulness program can improve emotion regulation among youth aged 15-19 years who attend an alternative school. Participants will complete a baseline survey package using an iPad. They will then receive an adapted version of the 6-session Learning to BREATHE Program as part of a course they are taking at their school. Students will again complete a survey package within 2 weeks of completing the program. The investigator will compare baseline and post-intervention survey responses to see if the program improved emotion regulation, as well as several secondary psychosocial and behavioral outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 16, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

November 21, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

December 1, 2023

Status Verified

November 1, 2023

Enrollment Period

3 months

First QC Date

November 8, 2022

Last Update Submit

November 29, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in emotion regulation on the 18-item Difficulties in Emotion Regulation Scale - Short Form (DERS-SF)

    The DERS-SF has excellent psychometric properties regardless of age and gender variation. A 5-point Likert scale from 1 (almost never) to 5 (almost always) is employed, with higher scores indicating greater emotion regulation impairment or dysregulation (Week 10 Score - Baseline Score)

    Baseline and Week 10

  • Change from baseline in emotion regulation on the 1-item Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA)

    The ERQ-CA assesses use of two emotion regulation strategies: cognitive reappraisal where a person attempts to change how they think about a situation to change its emotional impact, and expressive suppression where a person attempts to inhibit the behavioural expression of their emotions. A 5-point Likert scale from 1 (almost never) to 5 (almost always) is employed, with higher scores indicating greater emotion regulation impairment or dysregulation (Week 10 Score - Baseline Score).

    Baseline and Week 10

Secondary Outcomes (6)

  • Change from baseline in mindfulness on the 10-item Child and Adolescent Mindfulness Measure (CAMM).

    Baseline and Week 10

  • Change from baseline in anxiety and depression symptoms on the 4-item Patient Health Questionnaire (PHQ-4).

    Baseline and Week 10

  • Change from baseline in self-esteem on the 5-item Brief Rosenberg Self-Esteem Scale.

    Baseline and Week 10

  • Change from baseline in school connectedness on an adapted version of the the National Longitudinal Study of Adolescent Health School Connectedness Scale (NLSAH-SCS).

    Baseline and Week 10

  • Change from baseline in home connectedness on an adapted 5-item version of the National Longitudinal Study of Adolescent Health School Connectedness Scale (NLSAH-SCS).

    Baseline and Week 10

  • +1 more secondary outcomes

Study Arms (1)

Mindfulness intervention

EXPERIMENTAL

The intervention will consist of 6 one-hour sessions delivered once per week in a classroom at an alternative high school during normal school hours.

Behavioral: Mindfulness Intervention

Interventions

6-week mindfulness intervention

Also known as: Learning to Breathe Program
Mindfulness intervention

Eligibility Criteria

Age15 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Aged 15-19 years of age
  • Enrolled in two specific courses offered at Victoria Park High School

You may not qualify if:

  • Unwilling to give consent
  • Lack capacity to provide informed consent as determined by the educational assistant who will complete the informed consent process with each potential participant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Victoria Park High School

Lethbridge, Alberta, T1J 2M4, Canada

Location

MeSH Terms

Conditions

Substance-Related DisordersAdolescent BehaviorEmotional RegulationSocial Behavior

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersBehaviorSelf-Control

Study Officials

  • Cheryl Currie, PhD

    University of Lethbridge

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 8, 2022

First Posted

November 16, 2022

Study Start

November 21, 2022

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

December 1, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations