search
Back to results

Targeting Adolescent Depressive Symptoms Via Brief, Web-Based Interventions

Primary Purpose

Depression, Depressive Disorder, Behavioral Symptoms

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Growth Mindset Online Single-Session Program
Self-Kindness Online Single-Session Program
Supportive Therapy Online Single-Session Program (Control)
Sponsored by
Child Mind Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Adolescent, Therapeutics, Mental Health

Eligibility Criteria

11 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy Brain Network study participants
  • Between the ages of 11-17 (inclusive)
  • Fluent in English

Exclusion Criteria:

  • Youth with parent-reported intellectual disability

Sites / Locations

  • Child Mind InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Growth Mindset Intervention

Self-Kindness Intervention

Supportive Therapy Intervention

Arm Description

Includes 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.

Includes 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.

Includes 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Screen for Child Anxiety and Related Disorders; Youth-Report
Youth-report measure of youth anxiety symptoms. Youth rate 41 items reflecting anxiety symptoms on a 0-2 scale. Scores range from 0-82, with higher scores indicating greater symptom severity.
Change in Implicit Theories of Personality Questionnaire; Youth-Report
Youth rate their agreement with 3 statements linked to the malleability of personality (e.g. "Your personality is something about you that you can't change very much"), on a 1-6 scale. Higher mean scores on these three items indicate a stronger fixed personality mindset, a lower scores, a stronger growth personality mindset (range: 1-6).
Change in Self-Hate Scale; Youth-Report
Youth rate 7 items evaluating the degree of their self-dislike (e.g., "I am ashamed of myself") on a 1-7 scale, with higher scores indicating greater levels of self-hate (possible score range: 7-49).
Change in Self-Judgment Subscale of Self-Compassion Scale; Youth-Report
Youth rate their agreement with 5 items reflecting self-judgment (e.g., "When times are really difficult, I tend to be tough on myself") on a 1-5 scale. These 5 items are a subscale within the Self-Compassion Scale, a 26-item self-report questionnaire measuring the six components of self-compassion (of which self-judgment is one). A mean is computed across responses to all 5 items to form a total Self-Judgment score (range: 1 to 5).
Change in Fear of Self-Compassion Scale; Youth-Report
Youth rate 15 items reflecting their level of fear about acting or thinking compassionately toward the self (e.g., 'I worry that if I start to develop compassion for myself I will become dependent on it') on a 0-4 scale. Scores range from 0-60.
Change in Beck Hopelessness Scale-Short Version; Youth-Report
Youth rate their agreement on 4 items reflecting their degree of hopelessness (e.g. "My future seems dark to me"), on a 0-3 scale. This 4-item scale is a shortened version of the 20-item Beck Hopelessness Scale designed for brief psychological screening purposes. Scores on the 4-item short version range from 0-12, with higher scores indicating higher levels of youth hopelessness.
Change in Primary Perceived Control Scale for Children; Youth-Report
Youth rate their agreement with 24 items reflecting their perceived ability to influence or alter objective events or conditions through personal effort (e.g., "I can do well on tests if I study hard") on a 0-3 scale. Scores range from 0-72, with higher scores indicating greater primary perceived control.
Change in Secondary Perceived Control Scale for Children; Youth-Report
Youth rate agreement with 20 items reflecting perceived ability to shape the personal impact of objective conditions on oneself, by adjusting oneself to fit those conditions (e.g. "When something bad happens, I can find a way to think about it that makes me feel better") on a 0-3 scale. Scores range from 0-60, with higher scores indicating greater secondary perceived control.

Full Information

First Posted
August 21, 2019
Last Updated
October 2, 2019
Sponsor
Child Mind Institute
Collaborators
Stony Brook University
search

1. Study Identification

Unique Protocol Identification Number
NCT04066985
Brief Title
Targeting Adolescent Depressive Symptoms Via Brief, Web-Based Interventions
Official Title
Targeting Adolescent Depressive Symptoms: Effects of Two Single-Session, Online Interventions
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
October 31, 2020 (Anticipated)
Study Completion Date
October 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Child Mind Institute
Collaborators
Stony Brook University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Major depression (MD) is the leading cause of disability in youth, with a global economic burden of >$210 billion annually (Whiteford et al., 2013). However, up to 70% of youth with MD do not receive services (Vitiello et al., 2011). Even among those who do access treatment, 30-65% fail to respond (March et al, 2007), demonstrating a significant need for more potent, accessible interventions for adolescent depressive symptoms and disorders. The goal of this project is to assess the acceptability and effectiveness of two computerized, single-session interventions that may reduce depressive symptoms in adolescents. Single-session interventions (SSIs) have shown promise in preventing and reducing youth mental health problems (see Schleider & Weisz, 2017, for a meta-analysis). The present trial will be the first to evaluate the effectiveness of two distinct SSIs, targeting different types of depressive symptoms, in comparison to an active, previously-established comparison intervention. The first SSI is designed to instill a growth mindset in youth: the belief that personal behaviors and characteristics, such as depressive symptoms, are malleable rather than fixed (Schleider, Abel, & Weisz, 2015). In previous trial, a single-session growth mindset intervention significantly reduced depressive symptoms in high symptom-adolescents (Schleider & Weisz, 2018); however, questions still remain about the benefits of this intervention across all adolescents. The second SSI, which has not been tested previously, is designed to strengthen self-kindness and reduce self-hate. This SSI targets self-hate because it is a symptom of depression that has been identified as especially "central," or more important to the maintenance of other kinds of depressive symptoms, in adolescents at-risk for emotional difficulties. Because self-hate is an especially central symptom, an SSI that systematically, precisely reduces it may serve as an especially potent intervention. This study will test whether either the growth mindset SSI (GM-SSI), the self-kindness SSI (SK-SSI), or both reduces symptoms of depression in adolescents, relative to an active "supportive therapy" SSI, which teaches adolescents to share their emotions with trusted others (Schleider & Weisz 2018). Our second goal is to evaluate whether the GM-SSI and SK-SSI target and specifically improve proximal targets, unique to each SSI, immediately after SSI administration, relative to the comparison intervention (e.g., whether the GM-SSI improves perceived control relative to the comparison intervention, and whether the SK-SSI alters fear of self-compassion relative to the comparison intervention). To test these possibilities, adolescents recruited from the Healthy Brain Network research study (Advarra Pro00012309) (N=501, 167 per SSI condition; ages 11-17) will be randomized to one of three intervention conditions: the web-based GM-SSI; the web-based SK-SSI; or the web-based, supportive therapy (control) SSI, which has been validated previously (Schleider & Weisz, 2016; Schleider & Weisz, 2018). Adolescents will report on their depression symptoms, perceived control, self-compassion, and related domains of functioning at pre-intervention, post-intervention, and at three-month follow-up. The investigators predict the growth mindset and self-kindness web-based interventions will both lead to larger reductions in adolescent depression symptoms relative to the control intervention. Additionally, the investigators predict that the growth mindset SSI will lead to larger reductions in perceived control than the supportive therapy intervention, and that the self-kindness SSI will lead to larger reductions in fear of self-compassion relative to the control program. Results may identify two novel, potent, and brief interventions for adolescent depressive symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Depressive Disorder, Behavioral Symptoms, Mood Disorders, Mental Disorders
Keywords
Depression, Adolescent, Therapeutics, Mental Health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
All adolescent participants will be provided a study identifier and prompted to complete self-report questionnaires. Subsequently, a random number generator (embedded within Mindlogger, a Child Mind Institute developed data collection application) will be used to assign participants to one of three intervention conditions.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Neither investigators, outcomes assessor, youth, nor parents will know the condition assigned to the youth.
Allocation
Randomized
Enrollment
501 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Growth Mindset Intervention
Arm Type
Experimental
Arm Description
Includes 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.
Arm Title
Self-Kindness Intervention
Arm Type
Experimental
Arm Description
Includes 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.
Arm Title
Supportive Therapy Intervention
Arm Type
Active Comparator
Arm Description
Includes 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.
Intervention Type
Behavioral
Intervention Name(s)
Growth Mindset Online Single-Session Program
Other Intervention Name(s)
Project Personality
Intervention Description
30minute self-administered program for youths
Intervention Type
Behavioral
Intervention Name(s)
Self-Kindness Online Single-Session Program
Other Intervention Name(s)
Teenage Goals Project
Intervention Description
30minute self-administered program for youths
Intervention Type
Behavioral
Intervention Name(s)
Supportive Therapy Online Single-Session Program (Control)
Other Intervention Name(s)
Share Your Feelings Program
Intervention Description
30minute self-administered active comparator program for youths
Primary Outcome Measure Information:
Title
Change in Mood and Feelings Questionnaire; Youth-Report
Description
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.
Time Frame
[Baseline to 3-month follow-up.]
Secondary Outcome Measure Information:
Title
Change in Screen for Child Anxiety and Related Disorders; Youth-Report
Description
Youth-report measure of youth anxiety symptoms. Youth rate 41 items reflecting anxiety symptoms on a 0-2 scale. Scores range from 0-82, with higher scores indicating greater symptom severity.
Time Frame
Baseline to 3-month follow-up.
Title
Change in Implicit Theories of Personality Questionnaire; Youth-Report
Description
Youth rate their agreement with 3 statements linked to the malleability of personality (e.g. "Your personality is something about you that you can't change very much"), on a 1-6 scale. Higher mean scores on these three items indicate a stronger fixed personality mindset, a lower scores, a stronger growth personality mindset (range: 1-6).
Time Frame
Baseline to post-intervention; baseline to 3-month follow-up.
Title
Change in Self-Hate Scale; Youth-Report
Description
Youth rate 7 items evaluating the degree of their self-dislike (e.g., "I am ashamed of myself") on a 1-7 scale, with higher scores indicating greater levels of self-hate (possible score range: 7-49).
Time Frame
Baseline to post-intervention; baseline to 3-month follow-up.
Title
Change in Self-Judgment Subscale of Self-Compassion Scale; Youth-Report
Description
Youth rate their agreement with 5 items reflecting self-judgment (e.g., "When times are really difficult, I tend to be tough on myself") on a 1-5 scale. These 5 items are a subscale within the Self-Compassion Scale, a 26-item self-report questionnaire measuring the six components of self-compassion (of which self-judgment is one). A mean is computed across responses to all 5 items to form a total Self-Judgment score (range: 1 to 5).
Time Frame
Baseline to post-intervention; baseline to 3-month follow-up.
Title
Change in Fear of Self-Compassion Scale; Youth-Report
Description
Youth rate 15 items reflecting their level of fear about acting or thinking compassionately toward the self (e.g., 'I worry that if I start to develop compassion for myself I will become dependent on it') on a 0-4 scale. Scores range from 0-60.
Time Frame
Baseline to post-intervention; baseline to 3-month follow-up.
Title
Change in Beck Hopelessness Scale-Short Version; Youth-Report
Description
Youth rate their agreement on 4 items reflecting their degree of hopelessness (e.g. "My future seems dark to me"), on a 0-3 scale. This 4-item scale is a shortened version of the 20-item Beck Hopelessness Scale designed for brief psychological screening purposes. Scores on the 4-item short version range from 0-12, with higher scores indicating higher levels of youth hopelessness.
Time Frame
Baseline to post-intervention; baseline to 3-month follow-up.
Title
Change in Primary Perceived Control Scale for Children; Youth-Report
Description
Youth rate their agreement with 24 items reflecting their perceived ability to influence or alter objective events or conditions through personal effort (e.g., "I can do well on tests if I study hard") on a 0-3 scale. Scores range from 0-72, with higher scores indicating greater primary perceived control.
Time Frame
Baseline to post-intervention; baseline to 3-month follow-up.
Title
Change in Secondary Perceived Control Scale for Children; Youth-Report
Description
Youth rate agreement with 20 items reflecting perceived ability to shape the personal impact of objective conditions on oneself, by adjusting oneself to fit those conditions (e.g. "When something bad happens, I can find a way to think about it that makes me feel better") on a 0-3 scale. Scores range from 0-60, with higher scores indicating greater secondary perceived control.
Time Frame
Baseline to post-intervention; baseline to 3-month follow-up.
Other Pre-specified Outcome Measures:
Title
Program Feedback Scale
Description
Youth rate agreement with 7 items reflecting their experience with the intervention to which they were assigned (e.g. "I enjoyed the program") on a 1-5 scale. Youth will be asked to complete a series of open-ended questions regarding their opinions about the program (e.g. "What did you like about the program? Please share as many true thoughts and feelings as you would like!").
Time Frame
Immediately post-intervention (0 - 2 minutes following the intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy Brain Network study participants Between the ages of 11-17 (inclusive) Fluent in English Exclusion Criteria: Youth with parent-reported intellectual disability
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lindsay M Alexander, MPH
Phone
646-625-4383
Email
Lindsay.Alexander@childmind.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lindsay M Alexander, MPH
Organizational Affiliation
Child Mind Institute
Official's Role
Study Director
Facility Information:
Facility Name
Child Mind Institute
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsay M Alexander, MPH
Phone
646-625-4383
Email
Lindsay.Alexander@childmind.org

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing 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.
Citations:
PubMed Identifier
28117056
Citation
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.
Results Reference
background
PubMed Identifier
25462109
Citation
Schleider 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.
Results Reference
background
PubMed Identifier
28921523
Citation
Schleider 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.
Results Reference
background
PubMed Identifier
27697671
Citation
Schleider 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.
Results Reference
background

Learn more about this trial

Targeting Adolescent Depressive Symptoms Via Brief, Web-Based Interventions

We'll reach out to this number within 24 hrs