Targeting Adolescent Depressive Symptoms Via Brief, Web-Based Interventions

Depression Clinical Trial

Official title:

Targeting Adolescent Depressive Symptoms: Effects of Two Single-Session, Online Interventions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04066985
• Other study ID #: Pro00034009
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: October 31, 2020

Study information

• Verified date: October 2019
• Source: Child Mind Institute
• Contact: Lindsay M Alexander, MPH
• Phone: 646-625-4383
• Email: Lindsay.Alexander[@]childmind.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 501
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Behavioral Symptoms
• Depression
• Depressive Disorder
• Disease
• Mental Disorders
• Mood Disorders

Intervention

Behavioral:
• Growth Mindset Online Single-Session Program
30minute self-administered program for youths
• Self-Kindness Online Single-Session Program
30minute self-administered program for youths
• Supportive Therapy Online Single-Session Program (Control)
30minute self-administered active comparator program for youths

Locations

Country	Name	City	State
United States	Child Mind Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Child Mind Institute	Stony Brook University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Program Feedback Scale	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!").	Immediately post-intervention (0 - 2 minutes following the intervention)
Primary	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	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.	Baseline to 3-month follow-up.
Secondary	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).	Baseline to post-intervention; baseline to 3-month follow-up.
Secondary	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).	Baseline to post-intervention; baseline to 3-month follow-up.
Secondary	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).	Baseline to post-intervention; baseline to 3-month follow-up.
Secondary	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.	Baseline to post-intervention; baseline to 3-month follow-up.
Secondary	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.	Baseline to post-intervention; baseline to 3-month follow-up.
Secondary	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.	Baseline to post-intervention; baseline to 3-month follow-up.
Secondary	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.	Baseline to post-intervention; baseline to 3-month follow-up.