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Testing Scalable, Single-Session Interventions for Adolescent Depression in the Context of COVID-19

Comparing Two Online Single-Session Interventions for Adolescent Depression: Outcomes of a Randomized Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04634903
Enrollment
2452
Registered
2020-11-18
Start date
2020-11-19
Completion date
2021-03-15
Last updated
2021-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

single-session interventions

Brief summary

Most mental health problems emerge by age 14, often leading to chronic impairments and adverse impacts for individuals, families, and societies. Any action-focused path to reducing the need-to-access gap will require moving beyond the dominant settings, formats, and systems that have constrained intervention delivery to date. In a fully-online trial, youths ages 13-16 will be randomized to 1 of 3 self-administered single-session interventions (SSIs): a behavioral activation SSI, targeting behavioral MD symptoms; an SSI teaching growth mindset, targeting cognitive MD symptoms; or a control SSI. The investigators will test each SSI's relative benefits, versus the control, on depressive symptoms and proximal outcomes such as hopelessness. Results will reveal whether SSIs that were designed to address behavioral versus cognitive symptoms differentially benefit adolescents with elevated depressive symptoms.

Interventions

Online, 30-minute self-administered program for youth

Online, 30-minute self-administered program for youth

Online, 30-minute self-administered program for youth

Sponsors

University of Denver
CollaboratorOTHER
Stony Brook University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Intervention model description

Participants will be randomized to the Behavioral Activation SSI (BA-SSI), Growth Mindset SSI (GM-SSI), or the Supportive Therapy SSI (ST-SSI; each 30 minutes in length).

Eligibility

Sex/Gender
ALL
Age
13 Years to 16 Years
Healthy volunteers
No

Inclusion criteria

* are fluent in English * have consistent internet and computer/laptop/smartphone access * report elevated depressive symptoms (a score of \>2 on the Patient Health Questionnaire-2 item version \[PHQ-2\])

Exclusion criteria

* fail to meet the above-listed inclusion criteria * exit the study prior to condition randomization * respond with either copy/pasted responses from text earlier in the intervention to any of free response questions * obvious lack of English fluency in open response questions * responding with random text in open response questions * duplicate responses from the same individual in baseline or follow-up surveys We will also exclude for primary analyses (but may run sensitivity analyses including them) any participants who provide responses of fewer than 3 words to writing prompts that ask for at least 2 sentences or more.

Design outcomes

Primary

MeasureTime frameDescription
Change in Adolescent Depressive Symptom SeverityPre-SSI to 3-month follow-upThe Children's Depression Inventory (CDI) 2 - short form (CDI-SF) is a reliable, valid measure of youth depression severity, normed for youth age and sex and yielding raw scores ranging from 0-24, where higher scores indicate more severe symptoms of depression.

Secondary

MeasureTime frameDescription
Change in State Hope Scale - Pathways SubscalePre-SSI to Immediately Post-SSI; Pre-SSI to 3-month follow-upThe State Hope Scale - Pathways Subscale asks participants to rate 3 statements based on how they think about themselves right now. Participants rate the 3 statements on an 8 point scale ranging from 0 (Definitely False) to 7 (Definitely True). Total score ranges, reflecting the average across all items, range from 0-7, with higher scores representing more flexible/greater perceived pathways to solving one's problems.
Change in Beck Hopelessness Scale - 4 Item VersionPre-SSI to Immediately Post-SSI; Pre-SSI to 3-month follow-up4 item version (BHS-4; referenced as 'How I Think Scale' in appended materials): This scale asks participants to rate 4 statements based on their sense of hopelessness. Participants rate the 4 statements on a 4 point scale ranging from 0 (Absolutely Disagree) to 3 (Absolutely Agree). Average scores across all items range from 0 to 3, with a higher score indicating greater levels of hopelessness.
Program Feedback ScaleImmediately Post-SSI onlyThe PFS asks youth to rate agreement with 7 statements indicating perceived acceptability of an SSI (e.g. I enjoyed the program) on a 5-point Likert scale (1=really disagree; 5=totally agree). A score of 3.5/5 or above on any given PFS item is interpreted as an acceptable rating on that item. Scores are calculated at the item-level, and higher scores reflect greater acceptability for each item.

Other

MeasureTime frameDescription
Perceived Socioeconomic and Social StatusPre-SSI onlyImmediately pre-intervention, participants will be asked to rate their perceived socioeconomic and social status using the two items from the MacArthur Scale of Subjective Social Status-Youth Version. Respondents indicate where they see themselves on a ladder with 10 rungs (range: 1 to 10 for both items, where 1 = families with most money/education/jobs and youth with highest respect/grades/social standing; 10 = families with least money/education/jobs and youth with lowest respect/grades/social standing).
Multidimensional Peer Victimization ScalePre-SSI onlyThe MVPS is a self-report scale assessing adolescents' experiences of peer victimization. This study will include the social manipulation, verbal victimization, and physical victimization scales, totaling 12 items (4 items per subscale). Higher scores on any given subscale indicate more frequent victimization of specific type. Adolescents rate how often peers have victimized them in various ways in the past year (e.g. called me names; tried to turn my friends against me).
UCLA Loneliness ScalePre-SSI onlyThe ULS is a widely used self-report scale of loneliness in adolescents. The brief 8-item version will be used here. Adolescents rate agreement with 8 items reflecting loneliness (e.g. I feel left out; I feel isolated from others). Higher summed-scores across all 8 items reflect higher levels of loneliness. The ULS has shown adequate reliability and validity in adolescent samples.
Self-Referential Encoding Task (SRET)Pre-SSIThe SRET is a web-based behavioral measure of self-referent information processing biases that assesses judgements of self-descriptiveness, response latencies and free recall of emotionally valanced stimuli. Participants make decisions about whether positive and negative adjectives are self-descriptive. Participants view various adjectives (26 positive adjectives, 26 negative adjectives) one at a time and make rapid judgments about whether or not each word presented described themselves following word offset. Participants will be told to use the Q or P keys on their keyboard to answer whether the word described them or not. Each trial will be followed by a 1,500 ms intertrial interval.
DiscriminationPre-SSIThe Expanded Everyday Discrimination Scale will be measured pre-intervention to gauge the levels of relatively minor, every-day, chronic discrimination experienced by participants. The original scale (Williams et al., 1997) asks participants, In your day-to-day life, how often do any of the following things happen to you? for 9 items (e.g. you are treated with less courtesy than other people are) on a 5-point Likert scale (1= never; 6 = almost every day). These items assess the participant's observations about how others treat and act around them on a daily basis. The expanded version of this scale includes a 10th item, You are followed around in stores. Scores on the Expanded Everyday Discrimination Scale range from 10-60, with higher scores indicating higher levels of chronic discrimination experienced by participants. Respondents are also asked to identify what they believe to be the main reason(s) for these experiences (e.g. gender, race, age, etc.).
Generalized Anxiety Disorder 7 (GAD-7)Pre-SSIThe GAD-7 measures the severity of clinical anxiety symptoms, based on diagnostic criteria for generalized anxiety disorder. The GAD-7 includes 7 items asking respondents how often, during the last 2 weeks, they were bothered by each of 7 anxiety symptoms. Response options are not at all, several days, more than half the days, and nearly every day, scored as 0, 1, 2, and 3, respectively; thus total sum-scores may range from 0-21 and average scores from 0 to 3.
Change in Behavioral Activation for Depression Scale - Short FormPre-SSI to 3-month follow-upYouths' approach versus disengagement from rewarding activities will be assessed via the BADS-SF, a 9-item self-report questionnaire with strong reliability, predictive validity, and sensitivity to change following BA for adolescent depression symptoms. The BADS-SF has two subscales, both of relevance to this study: Activation (goal-directed engagement in rewarding activities) and Avoidance (engagement in rumination and avoidance rather than active coping).
Change in COVID-19-related Trauma SymptomsPre-SSI to 3-month follow-upThe Child Trauma Screen-Reaction Scale (CTS-RS) is a reliable, valid self-report measure of youth traumatic stress symptom severity, including event-related somatic symptoms, intrusive memories, avoidance, sleep problems, and mood and behavioral changes. For this study, instructions will read: For many kids and teens, the COVID-19 (or 'coronavirus') pandemic has been scary or very upsetting. Sometimes, events that are scary or upsetting can affect how people think, feel, and act. The next questions ask how you have been feeling and thinking recently. Youth will rate 6 statements describing traumatic stress symptoms (e.g., 'strong feelings in your body when you think about COVID-19 (sweating, heart beats fast, feel sick)') according to their frequency over the past 30 days (Never/Rarely; 1-2 times in the past month; 1-2 times in the past week; 3+ times per week).
Disordered EatingPre-SSI to 3-month follow-upDisordered eating behaviors will be measured at pre-intervention and 3-month follow-up using The Dietary Restriction Screener. The DRS-2 is a 9-item measure evaluating restrictive eating, bingeing, and purging behaviors in participants. 6 items ask participants whether or not they have engaged in restrictive eating, bingeing, or purging behaviors in the past year or in the past 3 months (0 = no; 1 = yes). The other 3 items assess the frequency of these behaviors over the past 28 days.
Adverse Childhood Experiences (ACEs) ScalePre-SSI onlyThe ACEs questionnaire asks about exposure to violence, childhood emotional, physical, or sexual abuse, and household dysfunction during childhood. ACEs have shown robust associations with a range of adverse health and behavioral outcomes across the lifespan \[yes/no\]. Questions asked in this measure include: At any point since you were born… 1. Did you often or very often feel that… No one in your family loved you or thought you were important or special? or Your family didn't look out for each other, feel close to each other, or support each other? 2. Were your parents ever separated or divorced? 3. Did you live with anyone who was a problem drinker or alcoholic, or who used street drugs? 4. Was a household member depressed or mentally ill, or did a household member attempt suicide? 5. Did a household member go to prison?
Brief Screener for Tobacco, Alcohol, and Other Drugs (BSTAD)Pre-SSI onlyThe BSTAD questionnaire asks respondents to report retrospectively on their personal and friends' tobacco and drug use over the past year the past year (yes/no), including questions about how frequently (in days) the respondent recalls using alcohol, tobacco, and other drugs.
Perceived Pre-to-post SSI Change ItemsImmediately Post-SSI onlyParticipants rate their perceived changes in levels of pre- to post-SSI hopelessness and ability to solve problems. The questions are: Compared to before doing this activity, to what extent are you feeling hopeless right now? (Response options: much more hopeless = -2; a little more hopeless = -1; the same amount of hopeless = 0; a little less hopeless = 1; a lot less hopeless = 2). Compared to before doing this activity, to what extent are you able to solve the problems facing you right now? (Response options: Much less able to solve problems = -2; a little less able to solve problems = -1; the same amount able to solve problems = 0; a little more able to solve problems = 1; a lot more able to solve problems = 2)
COVID-19-related StressorsPre-SSI onlyYouths will self-report perceived family social status related to the COVID-19 pandemic began (ie current perceived family social status), along with which among several COVID-19-related challenges they have faced (e.g., parent has lost job; school has closed; less contact with friends; know someone who was sick with COVID-19; more conflict at home; feel bored/restless; other \[free response\]). Item choices will be adapted from those included in the CDC's publicly-available item bank for research on COVID-19.
Change in Self-Injurious Thoughts and Behaviors Interview-Short Form (SITBI-SF)Pre-SSI to 3-month follow-upFour items from a self-report version of the SITBI-SF were used to assess lifetime history of suicide ideation, suicide attempts, and deliberate self-harm. The SITBI-SF is a widely used measure of the continuum of suicidality and self-harm and has demonstrated high test-retest reliability, high internal consistency, and moderate-to-high concurrent validity. Score range for this measure can range widely (per wide variation in instances of self-harming behaviors across one's lifetime); thus, we anticipate a minimum score of 0 and are unable to predict the top (maximum) score.
Change in Implicit Personality Theory QuestionnairePre-SSI, Immediately Post-SSIThe IPTQ asks youth to rate the extent of their agreement with three statements linked to the malleability of personality, using a 1-to-7 Likert scale (e.g. Your personality is something about you that you can't change very much.) Higher mean scores (range: 1-7) on these three items indicate a stronger fixed personality mindset, lower scores, a stronger growth personality mindset.
Demographic QuestionsPre-SSI onlyParticipants will be asked to report demographic information including age, sex assigned at birth, gender identity, primary language, school grade, race/ethnicity, sexual/romantic attraction, experiences, and orientation, and zip code. This measure will also assess mental health treatment history and pubertal status.

Countries

United States

Participant flow

Participants by arm

ArmCount
Supportive Therapy SSI (ST-SSI)
The web-based supportive therapy (ST-SSI) intervention, called the Sharing Feelings Intervention, is designed to mimic supportive therapy (ST). The goals of the ST intervention are to encourage participants to identify and express feelings to close others; the intervention does not teach or emphasize specific skills or beliefs. In previous clinical trials, ST has resulted in significantly fewer reductions in youth internalizing problems compared to cognitive-behavioral and growth mindset interventions. The ST-SSI is designed to control for nonspecific aspects of intervention, including engagement in a computer program. It includes the same number of reading and writing activities as the other SSIs. Supportive Therapy SSI: Online, 30-minute self-administered program for youth
818
Behavioral Activation SSI (BA-SSI)
The BA-SSI include 5 elements: (1) An introduction to the program's rationale: that engaging in value-based activities can combat sad mood and low self-esteem; (2) Psychoeducation about depression, including how behavior shapes feelings and thoughts; (3) A life values assessment, where youth identify key areas from which they draw enjoyment and meaning; (4) Creation of an activity hierarchy, where youth identify and personalize (in guided exercises) 3 activities to target for change; and (5) An exercise in which youths write about benefits that might result from engaging in each activity; an obstacle that might keep them from doing the activities; and a strategy for overcoming identified obstacles. Behavioral Activation SSI: Online, 30-minute self-administered program for youth
821
Growth Mindset SSI (GM-SSI)
Program includes: An introduction to the brain and a lesson on neuroplasticity; Testimonials from older youths who describe their views that traits are malleable 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. Growth Mindset SSI: Online, 30-minute self-administered program for youth
813
Total2,452

Baseline characteristics

CharacteristicTotalSupportive Therapy SSI (ST-SSI)Behavioral Activation SSI (BA-SSI)Growth Mindset SSI (GM-SSI)
Age, Categorical
<=18 years
2452 Participants818 Participants821 Participants813 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
American Indian/Alaska Native
92 Participants36 Participants27 Participants29 Participants
Race/Ethnicity, Customized
Asian
310 Participants101 Participants109 Participants100 Participants
Race/Ethnicity, Customized
Black
257 Participants85 Participants84 Participants88 Participants
Race/Ethnicity, Customized
Hispanic
471 Participants159 Participants164 Participants148 Participants
Race/Ethnicity, Customized
Native Hawaiian/Pacific Islander
39 Participants14 Participants11 Participants14 Participants
Race/Ethnicity, Customized
Other
47 Participants19 Participants17 Participants11 Participants
Race/Ethnicity, Customized
Prefer not to say
24 Participants9 Participants5 Participants10 Participants
Race/Ethnicity, Customized
White
1632 Participants546 Participants536 Participants550 Participants
Region of Enrollment
United States
2452 participants818 participants821 participants813 participants
Sex/Gender, Customized
Female
2160 Participants723 Participants718 Participants719 Participants
Sex/Gender, Customized
Male
251 Participants87 Participants86 Participants78 Participants
Sex/Gender, Customized
Other
21 Participants2 Participants12 Participants7 Participants
Sex/Gender, Customized
Prefer not to say
20 Participants6 Participants5 Participants9 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 8180 / 8210 / 813
other
Total, other adverse events
0 / 8180 / 8210 / 813
serious
Total, serious adverse events
0 / 8180 / 8210 / 813

Outcome results

Primary

Change in Adolescent Depressive Symptom Severity

The Children's Depression Inventory (CDI) 2 - short form (CDI-SF) is a reliable, valid measure of youth depression severity, normed for youth age and sex and yielding raw scores ranging from 0-24, where higher scores indicate more severe symptoms of depression.

Time frame: Pre-SSI to 3-month follow-up

ArmMeasureGroupValue (MEAN)Dispersion
Supportive Therapy SSI (ST-SSI)Change in Adolescent Depressive Symptom SeverityPre-Intervention CDI-II Score14.31 Score on a scaleStandard Deviation 4.12
Supportive Therapy SSI (ST-SSI)Change in Adolescent Depressive Symptom Severity3-month follow up CDI-II score12.57 Score on a scaleStandard Deviation 4.97
Behavioral Activation SSI (BA-SSI)Change in Adolescent Depressive Symptom SeverityPre-Intervention CDI-II Score14.15 Score on a scaleStandard Deviation 4.06
Behavioral Activation SSI (BA-SSI)Change in Adolescent Depressive Symptom Severity3-month follow up CDI-II score11.47 Score on a scaleStandard Deviation 5.04
Growth Mindset SSI (GM-SSI)Change in Adolescent Depressive Symptom SeverityPre-Intervention CDI-II Score14.22 Score on a scaleStandard Deviation 4.13
Growth Mindset SSI (GM-SSI)Change in Adolescent Depressive Symptom Severity3-month follow up CDI-II score11.58 Score on a scaleStandard Deviation 5.08
Secondary

Change in Beck Hopelessness Scale - 4 Item Version

4 item version (BHS-4; referenced as 'How I Think Scale' in appended materials): This scale asks participants to rate 4 statements based on their sense of hopelessness. Participants rate the 4 statements on a 4 point scale ranging from 0 (Absolutely Disagree) to 3 (Absolutely Agree). Average scores across all items range from 0 to 3, with a higher score indicating greater levels of hopelessness.

Time frame: Pre-SSI to Immediately Post-SSI; Pre-SSI to 3-month follow-up

ArmMeasureGroupValue (MEAN)Dispersion
Supportive Therapy SSI (ST-SSI)Change in Beck Hopelessness Scale - 4 Item VersionPre-intervention1.71 Score on a scaleStandard Deviation 0.76
Supportive Therapy SSI (ST-SSI)Change in Beck Hopelessness Scale - 4 Item Version3-month follow up1.51 Score on a scaleStandard Deviation 0.82
Supportive Therapy SSI (ST-SSI)Change in Beck Hopelessness Scale - 4 Item VersionPost-intervention1.36 Score on a scaleStandard Deviation 0.75
Behavioral Activation SSI (BA-SSI)Change in Beck Hopelessness Scale - 4 Item VersionPre-intervention1.72 Score on a scaleStandard Deviation 0.77
Behavioral Activation SSI (BA-SSI)Change in Beck Hopelessness Scale - 4 Item VersionPost-intervention1.22 Score on a scaleStandard Deviation 0.73
Behavioral Activation SSI (BA-SSI)Change in Beck Hopelessness Scale - 4 Item Version3-month follow up1.37 Score on a scaleStandard Deviation 0.8
Growth Mindset SSI (GM-SSI)Change in Beck Hopelessness Scale - 4 Item Version3-month follow up1.39 Score on a scaleStandard Deviation 0.83
Growth Mindset SSI (GM-SSI)Change in Beck Hopelessness Scale - 4 Item VersionPost-intervention1.21 Score on a scaleStandard Deviation 0.72
Growth Mindset SSI (GM-SSI)Change in Beck Hopelessness Scale - 4 Item VersionPre-intervention1.72 Score on a scaleStandard Deviation 0.76
Secondary

Change in State Hope Scale - Pathways Subscale

The State Hope Scale - Pathways Subscale asks participants to rate 3 statements based on how they think about themselves right now. Participants rate the 3 statements on an 8 point scale ranging from 0 (Definitely False) to 7 (Definitely True). Total score ranges, reflecting the average across all items, range from 0-7, with higher scores representing more flexible/greater perceived pathways to solving one's problems.

Time frame: Pre-SSI to Immediately Post-SSI; Pre-SSI to 3-month follow-up

ArmMeasureGroupValue (MEAN)Dispersion
Supportive Therapy SSI (ST-SSI)Change in State Hope Scale - Pathways Subscale3-month follow up4.89 Score on a scaleStandard Deviation 1.64
Supportive Therapy SSI (ST-SSI)Change in State Hope Scale - Pathways SubscalePost-intervention5.26 Score on a scaleStandard Deviation 1.52
Supportive Therapy SSI (ST-SSI)Change in State Hope Scale - Pathways SubscalePre-intervention3.88 Score on a scaleStandard Deviation 1.39
Behavioral Activation SSI (BA-SSI)Change in State Hope Scale - Pathways SubscalePre-intervention3.93 Score on a scaleStandard Deviation 1.4
Behavioral Activation SSI (BA-SSI)Change in State Hope Scale - Pathways SubscalePost-intervention5.68 Score on a scaleStandard Deviation 1.43
Behavioral Activation SSI (BA-SSI)Change in State Hope Scale - Pathways Subscale3-month follow up5.06 Score on a scaleStandard Deviation 1.63
Growth Mindset SSI (GM-SSI)Change in State Hope Scale - Pathways Subscale3-month follow up5.17 Score on a scaleStandard Deviation 1.65
Growth Mindset SSI (GM-SSI)Change in State Hope Scale - Pathways SubscalePost-intervention5.50 Score on a scaleStandard Deviation 1.48
Growth Mindset SSI (GM-SSI)Change in State Hope Scale - Pathways SubscalePre-intervention3.96 Score on a scaleStandard Deviation 1.44
Secondary

Program Feedback Scale

The PFS asks youth to rate agreement with 7 statements indicating perceived acceptability of an SSI (e.g. I enjoyed the program) on a 5-point Likert scale (1=really disagree; 5=totally agree). A score of 3.5/5 or above on any given PFS item is interpreted as an acceptable rating on that item. Scores are calculated at the item-level, and higher scores reflect greater acceptability for each item.

Time frame: Immediately Post-SSI only

Population: Mean item-level scores ranging from 1-5 are reported for each of 7 PFS items. Items were administered at post-intervention only.

ArmMeasureGroupValue (MEAN)Dispersion
Supportive Therapy SSI (ST-SSI)Program Feedback ScalePFS Item 1: Enjoyed Program3.80 score on a scaleStandard Deviation 0.79
Supportive Therapy SSI (ST-SSI)Program Feedback ScalePFS item 7: I agree with the program's message4.50 score on a scaleStandard Deviation 0.62
Supportive Therapy SSI (ST-SSI)Program Feedback ScalePFS item 2: Understood Program4.54 score on a scaleStandard Deviation 0.56
Supportive Therapy SSI (ST-SSI)Program Feedback ScalePFS Item 3: Program was Easy to Use4.46 score on a scaleStandard Deviation 0.64
Supportive Therapy SSI (ST-SSI)Program Feedback ScalePFS Item 4: I tried my hardest on the program4.45 score on a scaleStandard Deviation 0.65
Supportive Therapy SSI (ST-SSI)Program Feedback ScalePFS item 6: I would recommend this program to a friend3.97 score on a scaleStandard Deviation 0.95
Supportive Therapy SSI (ST-SSI)Program Feedback ScalePFS item 5: This program would be helpful to other kids4.24 score on a scaleStandard Deviation 0.81
Behavioral Activation SSI (BA-SSI)Program Feedback ScalePFS item 6: I would recommend this program to a friend4.12 score on a scaleStandard Deviation 0.89
Behavioral Activation SSI (BA-SSI)Program Feedback ScalePFS item 2: Understood Program4.46 score on a scaleStandard Deviation 0.49
Behavioral Activation SSI (BA-SSI)Program Feedback ScalePFS Item 3: Program was Easy to Use4.42 score on a scaleStandard Deviation 0.59
Behavioral Activation SSI (BA-SSI)Program Feedback ScalePFS item 7: I agree with the program's message4.54 score on a scaleStandard Deviation 0.57
Behavioral Activation SSI (BA-SSI)Program Feedback ScalePFS Item 4: I tried my hardest on the program4.42 score on a scaleStandard Deviation 0.69
Behavioral Activation SSI (BA-SSI)Program Feedback ScalePFS Item 1: Enjoyed Program3.93 score on a scaleStandard Deviation 0.73
Behavioral Activation SSI (BA-SSI)Program Feedback ScalePFS item 5: This program would be helpful to other kids4.30 score on a scaleStandard Deviation 0.76
Growth Mindset SSI (GM-SSI)Program Feedback ScalePFS Item 1: Enjoyed Program3.83 score on a scaleStandard Deviation 0.77
Growth Mindset SSI (GM-SSI)Program Feedback ScalePFS item 7: I agree with the program's message4.47 score on a scaleStandard Deviation 0.7
Growth Mindset SSI (GM-SSI)Program Feedback ScalePFS item 2: Understood Program4.48 score on a scaleStandard Deviation 0.64
Growth Mindset SSI (GM-SSI)Program Feedback ScalePFS item 6: I would recommend this program to a friend3.93 score on a scaleStandard Deviation 1
Growth Mindset SSI (GM-SSI)Program Feedback ScalePFS Item 4: I tried my hardest on the program4.45 score on a scaleStandard Deviation 0.67
Growth Mindset SSI (GM-SSI)Program Feedback ScalePFS Item 3: Program was Easy to Use4.48 score on a scaleStandard Deviation 0.64
Growth Mindset SSI (GM-SSI)Program Feedback ScalePFS item 5: This program would be helpful to other kids4.20 score on a scaleStandard Deviation 0.83
Other Pre-specified

Adverse Childhood Experiences (ACEs) Scale

The ACEs questionnaire asks about exposure to violence, childhood emotional, physical, or sexual abuse, and household dysfunction during childhood. ACEs have shown robust associations with a range of adverse health and behavioral outcomes across the lifespan \[yes/no\]. Questions asked in this measure include: At any point since you were born… 1. Did you often or very often feel that… No one in your family loved you or thought you were important or special? or Your family didn't look out for each other, feel close to each other, or support each other? 2. Were your parents ever separated or divorced? 3. Did you live with anyone who was a problem drinker or alcoholic, or who used street drugs? 4. Was a household member depressed or mentally ill, or did a household member attempt suicide? 5. Did a household member go to prison?

Time frame: Pre-SSI only

Other Pre-specified

Brief Screener for Tobacco, Alcohol, and Other Drugs (BSTAD)

The BSTAD questionnaire asks respondents to report retrospectively on their personal and friends' tobacco and drug use over the past year the past year (yes/no), including questions about how frequently (in days) the respondent recalls using alcohol, tobacco, and other drugs.

Time frame: Pre-SSI only

Other Pre-specified

Change in Behavioral Activation for Depression Scale - Short Form

Youths' approach versus disengagement from rewarding activities will be assessed via the BADS-SF, a 9-item self-report questionnaire with strong reliability, predictive validity, and sensitivity to change following BA for adolescent depression symptoms. The BADS-SF has two subscales, both of relevance to this study: Activation (goal-directed engagement in rewarding activities) and Avoidance (engagement in rumination and avoidance rather than active coping).

Time frame: Pre-SSI to 3-month follow-up

Other Pre-specified

Change in COVID-19-related Trauma Symptoms

The Child Trauma Screen-Reaction Scale (CTS-RS) is a reliable, valid self-report measure of youth traumatic stress symptom severity, including event-related somatic symptoms, intrusive memories, avoidance, sleep problems, and mood and behavioral changes. For this study, instructions will read: For many kids and teens, the COVID-19 (or 'coronavirus') pandemic has been scary or very upsetting. Sometimes, events that are scary or upsetting can affect how people think, feel, and act. The next questions ask how you have been feeling and thinking recently. Youth will rate 6 statements describing traumatic stress symptoms (e.g., 'strong feelings in your body when you think about COVID-19 (sweating, heart beats fast, feel sick)') according to their frequency over the past 30 days (Never/Rarely; 1-2 times in the past month; 1-2 times in the past week; 3+ times per week).

Time frame: Pre-SSI to 3-month follow-up

Other Pre-specified

Change in Implicit Personality Theory Questionnaire

The IPTQ asks youth to rate the extent of their agreement with three statements linked to the malleability of personality, using a 1-to-7 Likert scale (e.g. Your personality is something about you that you can't change very much.) Higher mean scores (range: 1-7) on these three items indicate a stronger fixed personality mindset, lower scores, a stronger growth personality mindset.

Time frame: Pre-SSI, Immediately Post-SSI

Other Pre-specified

Change in Self-Injurious Thoughts and Behaviors Interview-Short Form (SITBI-SF)

Four items from a self-report version of the SITBI-SF were used to assess lifetime history of suicide ideation, suicide attempts, and deliberate self-harm. The SITBI-SF is a widely used measure of the continuum of suicidality and self-harm and has demonstrated high test-retest reliability, high internal consistency, and moderate-to-high concurrent validity. Score range for this measure can range widely (per wide variation in instances of self-harming behaviors across one's lifetime); thus, we anticipate a minimum score of 0 and are unable to predict the top (maximum) score.

Time frame: Pre-SSI to 3-month follow-up

Other Pre-specified

COVID-19-related Stressors

Youths will self-report perceived family social status related to the COVID-19 pandemic began (ie current perceived family social status), along with which among several COVID-19-related challenges they have faced (e.g., parent has lost job; school has closed; less contact with friends; know someone who was sick with COVID-19; more conflict at home; feel bored/restless; other \[free response\]). Item choices will be adapted from those included in the CDC's publicly-available item bank for research on COVID-19.

Time frame: Pre-SSI only

Other Pre-specified

Demographic Questions

Participants will be asked to report demographic information including age, sex assigned at birth, gender identity, primary language, school grade, race/ethnicity, sexual/romantic attraction, experiences, and orientation, and zip code. This measure will also assess mental health treatment history and pubertal status.

Time frame: Pre-SSI only

Other Pre-specified

Discrimination

The Expanded Everyday Discrimination Scale will be measured pre-intervention to gauge the levels of relatively minor, every-day, chronic discrimination experienced by participants. The original scale (Williams et al., 1997) asks participants, In your day-to-day life, how often do any of the following things happen to you? for 9 items (e.g. you are treated with less courtesy than other people are) on a 5-point Likert scale (1= never; 6 = almost every day). These items assess the participant's observations about how others treat and act around them on a daily basis. The expanded version of this scale includes a 10th item, You are followed around in stores. Scores on the Expanded Everyday Discrimination Scale range from 10-60, with higher scores indicating higher levels of chronic discrimination experienced by participants. Respondents are also asked to identify what they believe to be the main reason(s) for these experiences (e.g. gender, race, age, etc.).

Time frame: Pre-SSI

Other Pre-specified

Disordered Eating

Disordered eating behaviors will be measured at pre-intervention and 3-month follow-up using The Dietary Restriction Screener. The DRS-2 is a 9-item measure evaluating restrictive eating, bingeing, and purging behaviors in participants. 6 items ask participants whether or not they have engaged in restrictive eating, bingeing, or purging behaviors in the past year or in the past 3 months (0 = no; 1 = yes). The other 3 items assess the frequency of these behaviors over the past 28 days.

Time frame: Pre-SSI to 3-month follow-up

Other Pre-specified

Generalized Anxiety Disorder 7 (GAD-7)

The GAD-7 measures the severity of clinical anxiety symptoms, based on diagnostic criteria for generalized anxiety disorder. The GAD-7 includes 7 items asking respondents how often, during the last 2 weeks, they were bothered by each of 7 anxiety symptoms. Response options are not at all, several days, more than half the days, and nearly every day, scored as 0, 1, 2, and 3, respectively; thus total sum-scores may range from 0-21 and average scores from 0 to 3.

Time frame: Pre-SSI

Other Pre-specified

Multidimensional Peer Victimization Scale

The MVPS is a self-report scale assessing adolescents' experiences of peer victimization. This study will include the social manipulation, verbal victimization, and physical victimization scales, totaling 12 items (4 items per subscale). Higher scores on any given subscale indicate more frequent victimization of specific type. Adolescents rate how often peers have victimized them in various ways in the past year (e.g. called me names; tried to turn my friends against me).

Time frame: Pre-SSI only

Other Pre-specified

Perceived Pre-to-post SSI Change Items

Participants rate their perceived changes in levels of pre- to post-SSI hopelessness and ability to solve problems. The questions are: Compared to before doing this activity, to what extent are you feeling hopeless right now? (Response options: much more hopeless = -2; a little more hopeless = -1; the same amount of hopeless = 0; a little less hopeless = 1; a lot less hopeless = 2). Compared to before doing this activity, to what extent are you able to solve the problems facing you right now? (Response options: Much less able to solve problems = -2; a little less able to solve problems = -1; the same amount able to solve problems = 0; a little more able to solve problems = 1; a lot more able to solve problems = 2)

Time frame: Immediately Post-SSI only

Other Pre-specified

Perceived Socioeconomic and Social Status

Immediately pre-intervention, participants will be asked to rate their perceived socioeconomic and social status using the two items from the MacArthur Scale of Subjective Social Status-Youth Version. Respondents indicate where they see themselves on a ladder with 10 rungs (range: 1 to 10 for both items, where 1 = families with most money/education/jobs and youth with highest respect/grades/social standing; 10 = families with least money/education/jobs and youth with lowest respect/grades/social standing).

Time frame: Pre-SSI only

Other Pre-specified

Self-Referential Encoding Task (SRET)

The SRET is a web-based behavioral measure of self-referent information processing biases that assesses judgements of self-descriptiveness, response latencies and free recall of emotionally valanced stimuli. Participants make decisions about whether positive and negative adjectives are self-descriptive. Participants view various adjectives (26 positive adjectives, 26 negative adjectives) one at a time and make rapid judgments about whether or not each word presented described themselves following word offset. Participants will be told to use the Q or P keys on their keyboard to answer whether the word described them or not. Each trial will be followed by a 1,500 ms intertrial interval.

Time frame: Pre-SSI

Other Pre-specified

UCLA Loneliness Scale

The ULS is a widely used self-report scale of loneliness in adolescents. The brief 8-item version will be used here. Adolescents rate agreement with 8 items reflecting loneliness (e.g. I feel left out; I feel isolated from others). Higher summed-scores across all 8 items reflect higher levels of loneliness. The ULS has shown adequate reliability and validity in adolescent samples.

Time frame: Pre-SSI only

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026