Ignite Creation Date:
2024-05-06 @ 1:36 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04066985
Status:
UNKNOWN
Last Update Posted:
2019-10-04
First Post:
2019-08-21
Brief Title:
Targeting Adolescent Depressive Symptoms Via Brief Web-Based Interventions
Sponsor:
Child Mind Institute
Organization:
Child Mind Institute
Study Overview
Official Title:
Targeting Adolescent Depressive Symptoms Effects of Two Single-Session Online Interventions
Status:
UNKNOWN
Status Verified Date:
2019-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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 N501 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 andor 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 eg 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 N501 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
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 eg 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 N501 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None