The S.M.A.R.T. Project: Stress Management and Resilience Training for Teens

NCT03270943 | Completed Results DMC

• 2 other identifiers: 16-1864R34AT008822-01A1
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

The rate of depression increases markedly over the course of adolescence. Adolescents struggling with depression are often set on a maladaptive behavior trajectory which may lead to academic challenges, substance abuse, risky sexual behavior, impairment in relationship building, and suicidality. The S.M.A.R.T Project (Stress Management and Resilience Training for Teens) is designed to learn about mood in teens, and whether emotional well-being can be improved with an 8 week class. The study proposes to refine and test the feasibility of a mindfulness-based self-compassion training program for adolescents who are experiencing subsyndromal depression, comparing it with a "healthy lifestyles" group program as a comparison attention-control for the treatment intervention. Secondarily, the study will explore the impact of these programs on measures of psychopathology and well-being (i.e. depressive symptoms and resilience).

Conditions

Depression Mild; Resilience, Psychological; Adolescent Behavior

Outcome Measures

Primary Outcomes (1)

• Time to Incident Depression

  The Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric short form depression 8a: Raw Scores range from 0 - 32, with 0 being the lowest depression rating and 32 the highest depression rating. Analysis utilized t-score transformation with a population mean of 50 and standard deviation of 10. A score of 65 was used to indicate incident depression. The PROMIS measure used in lieu of the Short Mood and Feelings Questionnaire (SMFQ) due to increased measurement frequency. Higher scores indicate a greater level of depression.

  weekly for up to 36 weeks

Secondary Outcomes (3)

• Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Depression Scores

  Baseline, Week 8

• Change in SMFQ Scores

  Baseline, Week 8

• Change in Brief Resiliency Scale (BRS) Scores

  Baseline, Week 8

Other Outcomes (3)

• Trajectory of SMFQ-C Depression Score Change

  Up to 36 weeks

• Trajectory of PROMIS Depression Score Change

  up to 36 weeks

• Trajectory of BRS Score Change

  up to 36 weeks

Study Arms (2)

Mindful Self-Compassion (MFY)

EXPERIMENTAL

An 8-week mindfulness self-compassion course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.

Behavioral: MFY

Healthy Lifestyles (HLG)

ACTIVE COMPARATOR

An 8-week healthy lifestyles course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.

Behavioral: HLG

Interventions

MFY BEHAVIORAL

Mindful Self-Compassion course for teens

Mindful Self-Compassion (MFY)

HLG BEHAVIORAL

Healthy Lifestyles course for teens

Healthy Lifestyles (HLG)

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Adolescents age14-17 (inclusive) in high school (may turn 18 after enrollment).
• Score of at least 6 on the Quick Inventory Depressive Symptomatology (QIDS). Potential participants must be pre-screened with the QIDS assessment
• Clinical mental health assessment based on the Diagnostic Interview Schedule for Children-IV (DISC-IV) to screen for serious psychiatric illness, including current major depression
• Able to read and communicate in English
• Willing to be randomized to one of the two arms;
• Able to attend 8 weekly, 1.75 hour sessions, as well as complete self-report measures and homework
• Have access to a computer or other internet-enabled device.

You may not qualify if:

• Score of at least 6 on the QIDS (pre-screening);
• Suicidality or major depression as determined by Study Psychologist;
• Inability to speak, write, and read English;
• Active substance abuse, defined as active treatment for substance abuse, legal consequences/school suspensions associated with substance use, or ongoing family conflict associated with substance use;
• History of bipolar disorder, schizophrenia, severe autism, or psychiatric hospitalization within the past 2 years;
• Unable or unwilling to attend or participate in group sessions and/or self-report assessments;
• Current or prior participation in another intervention to address depression or psychiatric conditions;
• Prior formal training in mindfulness, such as a mindfulness course.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Christine Lathren, MD, MPH

Chapel Hill, North Carolina, 27599-7200, United States

Location

Related Publications (3)

• Bluth K, Roberson PN, Gaylord SA. A Pilot Study of a Mindfulness Intervention for Adolescents and the Potential Role of Self-Compassion in Reducing Stress. Explore (NY). 2015 Jul-Aug;11(4):292-5. doi: 10.1016/j.explore.2015.04.005. Epub 2015 Apr 28.

  PMID: 26005198 BACKGROUND

• Bluth K, Gaylord SA, Campo RA, Mullarkey MC, Hobbs L. Making Friends With Yourself: A Mixed Methods Pilot Study of a Mindful Self-Compassion Program for Adolescents. Mindfulness (N Y). 2016 Mar 1;7(2):479-492. doi: 10.1007/s12671-015-0476-6. Epub 2015 Dec 19.

  PMID: 27110301 BACKGROUND

• Bluth K, Roberson PN, Gaylord SA, Faurot KR, Grewen KM, Arzon S, Girdler SS. Does Self-compassion Protect Adolescents from Stress? J Child Fam Stud. 2016 Apr;25(4):1098-1109. doi: 10.1007/s10826-015-0307-3. Epub 2015 Oct 23. No abstract available.

  PMID: 26997856 BACKGROUND

MeSH Terms

Conditions

Adolescent Behavior

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Christine Lathren, MD, MPH
• Organization: University of North Carolina at Chapel Hill

lathren@email.unc.edu

919-966-8586

Study Officials

• Susan Gaylord, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The nature of the interventions tested in this study does not allow for masking of subjects, instructors, or other personnel involved in program delivery. To preserve unbiased outcome assessments, study personnel involved in clinical assessments or data analysis will be masked with respect to group assignment. To minimize differences in subject expectancy, the programs will be described to participants as two programs, both of which have been previously found to be beneficial to teens.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After the first two intervention-refinement groups, participants will be randomized to one of two groups: a mindful self-compassion program or an active attention control program. Randomization will be stratified by gender. As soon as 20 eligible adolescents qualify for enrollment, they will be allocated to either the MFY or healthy lifestyle groups, using a specially-designed computer program which utilizes a random number generator with a permuted block design to ensure that the number of subjects allocated to the two arms over time are equal and to conceal the allocation. This will continue through 3 additional cohorts of adolescents for a total sample size of 80 (including test groups). Randomization is designed to assess feasibility of the randomization plan, in addition to general feasibility issues of the delivery of the educational programs.

Study Record Dates

• First Submitted: August 25, 2017
• First Posted: September 1, 2017
• Study Start: September 5, 2017
• Primary Completion: June 3, 2020
• Study Completion: June 3, 2020
• Last Updated: May 18, 2021
• Results First Posted: May 18, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)