DepressionNCT04066985
Targeting Adolescent Depressive Symptoms Via Brief, Web-Based Interventions
A study testing Growth Mindset Online Single-Session Program and Self-Kindness Online Single-Session Program in people with Depression and Depressive Disorder, run by Child Mind Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Depressive Disorder, Behavioral Symptoms
- What is being tested?
- Growth Mindset Online Single-Session Program and Self-Kindness Online Single-Session Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 501 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 31 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy Brain Network study participants
- Between the ages of 11-17 (inclusive)
- Fluent in English
Who cannot join
- Youth with parent-reported intellectual disability
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Child Mind Institute
New York, New York, 10022
Lindsay M Alexander, MPH, 646-625-4383, Lindsay.Alexander@childmind.org
About this study
Official title: Targeting Adolescent Depressive Symptoms: Effects of Two Single-Session, Online Interventions
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.
Read the 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.
- Being tested
- Growth Mindset Online Single-Session Program, Self-Kindness Online Single-Session Program, Supportive Therapy Online Single-Session Program (Control)
- Keywords
- Depression, Adolescent, Therapeutics, Mental Health
- Medical subject headings
- Depression, Depressive Disorder, Behavioral Symptoms, Mood Disorders, Mental Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth Mindset Online Single-Session ProgramBehavioural
Also called Project Personality
30minute self-administered program for youths
Self-Kindness Online Single-Session ProgramBehavioural
Also called Teenage Goals Project
30minute self-administered program for youths
Supportive Therapy Online Single-Session Program (Control)Behavioural
Also called Share Your Feelings Program
30minute self-administered active comparator program for youths
| Study group | Role | What they receive |
|---|---|---|
| Growth Mindset Intervention | Experimental | 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. Receives: Behavioral: Growth Mindset Online Single-Session Program |
| Self-Kindness Intervention | Experimental | 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. Receives: Behavioral: Self-Kindness Online Single-Session Program |
| Supportive Therapy Intervention | Active comparator | 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. Receives: Behavioral: Supportive Therapy Online Single-Session Program (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: [Baseline to 3-month follow-up.]
Secondary outcomes (8)
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.
Measured: Baseline to 3-month follow-up.
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).
Measured: Baseline to post-intervention; baseline to 3-month follow-up.
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).
Measured: Baseline to post-intervention; baseline to 3-month follow-up.
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).
Measured: Baseline to post-intervention; baseline to 3-month follow-up.
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.
Measured: Baseline to post-intervention; baseline to 3-month follow-up.
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.
Measured: Baseline to post-intervention; baseline to 3-month follow-up.
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.
Measured: Baseline to post-intervention; baseline to 3-month follow-up.
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.
Measured: Baseline to post-intervention; baseline to 3-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start1 Oct 2019
- Primary completion31 Oct 2020 (estimated)
- Study completion31 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 501 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Child Mind Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Stony Brook University
- Responsible party
- Sponsor
- Investigators
- Lindsay M Alexander, MPH, Study director, Child Mind Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04066985
- Sponsor's protocol ID
- Pro00034009
- Status last verified
- Oct 2019
- First submitted
- 21 Aug 2019
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 28117056Schleider 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.
PubMed 25462109Schleider 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.
PubMed 28921523Schleider 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.
PubMed 27697671
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Adolescent Depressive Symptoms: Effects of Two Single-Session, Online Interventions
- ClinicalTrials.gov ID
- NCT04066985
- Acronym / sponsor ID
- Pro00034009
- Keywords
- Depression, Adolescent, Therapeutics, Mental Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 501 participants (estimated)
- Lead sponsor
- Child Mind InstituteUniversity, hospital or other
- Collaborators
- Stony Brook University
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 31 Oct 2020 (estimated)
- First posted
- 26 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Growth Mindset Intervention | Experimental | Behavioral: Growth Mindset Online Single-Session ProgramIncludes 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 | Experimental | Behavioral: Self-Kindness Online Single-Session ProgramIncludes 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 comparator | Behavioral: Supportive Therapy Online Single-Session Program (Control)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. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy Brain Network study participants
- Between the ages of 11-17 (inclusive)
- Fluent in English
Key exclusion criteria (1 listed)
- Youth with parent-reported intellectual disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Growth Mindset Online Single-Session ProgramAlso: Project Personality30minute self-administered program for youths | Behavioural | Growth Mindset Intervention |
| Self-Kindness Online Single-Session ProgramAlso: Teenage Goals Project30minute self-administered program for youths | Behavioural | Self-Kindness Intervention |
| Supportive Therapy Online Single-Session Program (Control)Also: Share Your Feelings Program30minute self-administered active comparator program for youths | Behavioural | Supportive Therapy Intervention |
Primary outcome
Change in Mood and Feelings Questionnaire; Youth-Report
Time frame: [Baseline to 3-month follow-up.]
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.
8 secondary outcomes
Change in Screen for Child Anxiety and Related Disorders; Youth-Report
Time frame: Baseline to 3-month follow-up.
Change in Implicit Theories of Personality Questionnaire; Youth-Report
Time frame: Baseline to post-intervention; baseline to 3-month follow-up.
Change in Self-Hate Scale; Youth-Report
Time frame: Baseline to post-intervention; baseline to 3-month follow-up.
Change in Self-Judgment Subscale of Self-Compassion Scale; Youth-Report
Time frame: Baseline to post-intervention; baseline to 3-month follow-up.
Change in Fear of Self-Compassion Scale; Youth-Report
Time frame: Baseline to post-intervention; baseline to 3-month follow-up.
Change in Beck Hopelessness Scale-Short Version; Youth-Report
Time frame: Baseline to post-intervention; baseline to 3-month follow-up.
Change in Primary Perceived Control Scale for Children; Youth-Report
Time frame: Baseline to post-intervention; baseline to 3-month follow-up.
Change in Secondary Perceived Control Scale for Children; Youth-Report
Time frame: Baseline to post-intervention; baseline to 3-month follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Background: PubMed 28117056Schleider 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.
- Background: PubMed 25462109Schleider 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.
- Background: PubMed 28921523Schleider 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.
- Background: PubMed 27697671Schleider 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lindsay M Alexander, MPH study director
Child Mind Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Growth Mindset Online Single-Session Program and Self-Kindness Online Single-Session Program in people with Depression and Depressive Disorder, run by Child Mind Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lindsay M Alexander, MPH (646-625-4383, Lindsay.Alexander@childmind.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mood and Feelings Questionnaire; Youth-Report (time frame: [Baseline to 3-month follow-up.]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04066985, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2019.