Targeting Adolescent Depressive Symptoms Via Brief, Web-Based Interventions
1 other identifier
interventional
501
1 country
1
Brief Summary
Major depression (MD) in youth is a serious psychiatric illness with extensive morbidity and mortality. The American Academy of Pediatrics recently released practice guidelines promoting primary care (PC)-based youth MD screening; however, even when diagnosed by PC providers, \<50% of youth with MD access treatment. Thus, a need exists for interventions that are feasible for youths and parents to access and complete-and that may strengthen parents' likelihood of pursuing longer-term services. Single-session interventions (SSIs) may help forward these goals. SSIs include elements of comprehensive treatments, but their brevity makes them easier to disseminate at scale. Meta-analytic evidence suggests SSIs can reduce youth psychopathology, including self-administered (e.g., online) SSIs. One computer-based SSI, teaching growth mindset (GM; viewing personal traits as malleable), has reduced adolescent depressive symptoms in multiple RCTs. A second computer-based SSI was recently developed to reduce youth depressive symptoms via targeting reductions in self-hate-a symptom identified as important for the maintenance of other depressive symptoms in teenagers. This study will test whether either the growth mindset SSI (GM-SSI), the self-kindness SSI (SK-SSI), or both SSIs reduce symptoms of depression in adolescents, relative to an active "supportive therapy" SSI, which teaches adolescents to share their emotions with trusted others. Youths participating in existing research through the Healthy Brain Network (N=501) will receive either the growth mindset SSI (GM-SSI), the self-kindness SSI (SK-SSI), or the supportive therapy SSI (ST-SSI). The investigators will examine whether the GM-SSI and/or the SK-SSI, versus the ST-SSI will reduce youth depressive symptoms across three months. Results may identify two novel, potent, and brief interventions for adolescent depressive symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable depression
Started Oct 2019
1 active site
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
August 21, 2019
CompletedFirst Posted
Study publicly available on registry
August 26, 2019
CompletedStudy Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2020
CompletedOctober 4, 2019
October 1, 2019
1.1 years
August 21, 2019
October 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Mood and Feelings Questionnaire; Youth-Report
Youth-report measure of youth depressive symptoms. Youth rate 33 items reflecting internalizing symptoms on a 0-2 scale. Scores range from 0-66, with higher scores indicating greater symptom severity.
[Baseline to 3-month follow-up.]
Secondary Outcomes (8)
Change in Screen for Child Anxiety and Related Disorders; Youth-Report
Baseline to 3-month follow-up.
Change in Implicit Theories of Personality Questionnaire; Youth-Report
Baseline to post-intervention; baseline to 3-month follow-up.
Change in Self-Hate Scale; Youth-Report
Baseline to post-intervention; baseline to 3-month follow-up.
Change in Self-Judgment Subscale of Self-Compassion Scale; Youth-Report
Baseline to post-intervention; baseline to 3-month follow-up.
Change in Fear of Self-Compassion Scale; Youth-Report
Baseline to post-intervention; baseline to 3-month follow-up.
- +3 more secondary outcomes
Other Outcomes (1)
Program Feedback Scale
Immediately post-intervention (0 - 2 minutes following the intervention)
Study Arms (3)
Growth Mindset Intervention
EXPERIMENTALIncludes one online, single-session program, the Growth Mindset Program. The 30-minute, self-administered youth program includes: An introduction to the brain and a lesson on neuroplasticity; Testimonials from older youths who describe their views that traits are malleable, due to the brain's plasticity; Further stories by older youths, describing times when they used "growth mindsets" to persevere during social/emotional setbacks; Study summaries noting how/why personality can change; And an exercise in which youths write notes to younger students, using scientific information to explain people's capacity for change.
Self-Kindness Intervention
EXPERIMENTALIncludes one online, single-session program, the Self-Kindness Program. The 30-minute, self-administered youth program includes: An introduction to the science behind why adolescents might think disliking themselves is necessary for success and thus fear self-compassion; Scientific evidence and testimonials from other teens that being self-compassionate actually predicts being more successful socially and academically; Evidence-based tips for overcoming common, fear of self-compassion based obstacles to self-compassion in day to day life; And an exercise in which youths write notes to younger students, using scientific information to explain the benefits of using self-kindness.
Supportive Therapy Intervention
ACTIVE COMPARATORIncludes one online, single-session active comparator program, the Supportive Therapy Intervention. The ST SSI is designed to control for nonspecific aspects of intervention, including engagement in a computer program. The 30-minute, self-administered control group program includes: vignettes written by older youths who describe times when they benefited from sharing their feelings with friends or family; the same number of reading and writing activities as the web-based growth mindset intervention. However, the only goals of the ST intervention are to encourage youths to identify and express feelings to close others; the intervention does not teach or emphasize specific skills or beliefs.
Interventions
30minute self-administered program for youths
30minute self-administered program for youths
30minute self-administered active comparator program for youths
Eligibility Criteria
You may qualify if:
- Healthy Brain Network study participants
- Between the ages of 11-17 (inclusive)
- Fluent in English
You may not qualify if:
- Youth with parent-reported intellectual disability
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Child Mind Institutelead
- Stony Brook Universitycollaborator
Study Sites (1)
Child Mind Institute
New York, New York, 10022, United States
Related Publications (4)
Schleider JL, Weisz JR. Little Treatments, Promising Effects? Meta-Analysis of Single-Session Interventions for Youth Psychiatric Problems. J Am Acad Child Adolesc Psychiatry. 2017 Feb;56(2):107-115. doi: 10.1016/j.jaac.2016.11.007. Epub 2016 Nov 25.
PMID: 28117056BACKGROUNDSchleider JL, Abel MR, Weisz JR. Implicit theories and youth mental health problems: a random-effects meta-analysis. Clin Psychol Rev. 2015 Feb;35:1-9. doi: 10.1016/j.cpr.2014.11.001. Epub 2014 Nov 7.
PMID: 25462109BACKGROUNDSchleider J, Weisz J. A single-session growth mindset intervention for adolescent anxiety and depression: 9-month outcomes of a randomized trial. J Child Psychol Psychiatry. 2018 Feb;59(2):160-170. doi: 10.1111/jcpp.12811. Epub 2017 Sep 18.
PMID: 28921523BACKGROUNDSchleider JL, Weisz JR. Reducing risk for anxiety and depression in adolescents: Effects of a single-session intervention teaching that personality can change. Behav Res Ther. 2016 Dec;87:170-181. doi: 10.1016/j.brat.2016.09.011. Epub 2016 Sep 26.
PMID: 27697671BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lindsay M Alexander, MPH
Child Mind Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Neither investigators, outcomes assessor, youth, nor parents will know the condition assigned to the youth.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2019
First Posted
August 26, 2019
Study Start
October 1, 2019
Primary Completion
October 31, 2020
Study Completion
October 31, 2020
Last Updated
October 4, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Protocol is outlined in this ClinicalTrials pre-registration. Statistical analysis plan will be uploaded to Open Science Framework prior to the study's onset October 31, 2019.
- Access Criteria
- Study protocol information is publicly available on clinicaltrials.gov. Statistical analysis plan will be made publicly available on Open Science Framework. IPD will be made publicly available on COINS and LORIS, and access to these databases requires a data usage agreement signed by the institution using the data.
De-identified individual-level participant data will be made publicly available in two databases: (1) COllaborative Informatics and Neuroimaging Suite (COINS), a HIPAA-compliant, open-source information system; (2) Longitudinal Online Research and Imaging System (LORIS), a HIPAA-compliant, web-based data and project management software. IPD associated with this project will be released to project collaborators upon the completion of the study (October 31, 2020). IPD associated with this project will be released to outside researchers at the next Healthy Brain Network quarterly data-release after the study's completion on October 31, 2020.