Trial Outcomes & Findings for Testing Scalable, Single-Session Interventions for Adolescent Depression in the Context of COVID-19 (NCT NCT04634903)

NCT ID: NCT04634903

Last Updated: 2021-05-25

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

2452 participants

Primary outcome timeframe

Pre-SSI to 3-month follow-up

Results posted on

2021-05-25

Participant Flow

Participant milestones

Participant milestones
Measure
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
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
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
Overall Study
STARTED
818
821
813
Overall Study
COMPLETED
669
732
653
Overall Study
NOT COMPLETED
149
89
160

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Supportive Therapy SSI (ST-SSI)
n=818 Participants
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
Behavioral Activation SSI (BA-SSI)
n=821 Participants
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
Growth Mindset SSI (GM-SSI)
n=813 Participants
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
Total
n=2452 Participants
Total of all reporting groups
Age, Categorical
<=18 years
818 Participants
n=99 Participants
821 Participants
n=107 Participants
813 Participants
n=206 Participants
2452 Participants
n=7 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Age, Categorical
>=65 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Sex/Gender, Customized
Female
723 Participants
n=99 Participants
718 Participants
n=107 Participants
719 Participants
n=206 Participants
2160 Participants
n=7 Participants
Sex/Gender, Customized
Male
87 Participants
n=99 Participants
86 Participants
n=107 Participants
78 Participants
n=206 Participants
251 Participants
n=7 Participants
Sex/Gender, Customized
Other
2 Participants
n=99 Participants
12 Participants
n=107 Participants
7 Participants
n=206 Participants
21 Participants
n=7 Participants
Sex/Gender, Customized
Prefer not to say
6 Participants
n=99 Participants
5 Participants
n=107 Participants
9 Participants
n=206 Participants
20 Participants
n=7 Participants
Race/Ethnicity, Customized
American Indian/Alaska Native
36 Participants
n=99 Participants
27 Participants
n=107 Participants
29 Participants
n=206 Participants
92 Participants
n=7 Participants
Race/Ethnicity, Customized
Asian
101 Participants
n=99 Participants
109 Participants
n=107 Participants
100 Participants
n=206 Participants
310 Participants
n=7 Participants
Race/Ethnicity, Customized
Hispanic
159 Participants
n=99 Participants
164 Participants
n=107 Participants
148 Participants
n=206 Participants
471 Participants
n=7 Participants
Race/Ethnicity, Customized
Native Hawaiian/Pacific Islander
14 Participants
n=99 Participants
11 Participants
n=107 Participants
14 Participants
n=206 Participants
39 Participants
n=7 Participants
Race/Ethnicity, Customized
White
546 Participants
n=99 Participants
536 Participants
n=107 Participants
550 Participants
n=206 Participants
1632 Participants
n=7 Participants
Race/Ethnicity, Customized
Black
85 Participants
n=99 Participants
84 Participants
n=107 Participants
88 Participants
n=206 Participants
257 Participants
n=7 Participants
Race/Ethnicity, Customized
Other
19 Participants
n=99 Participants
17 Participants
n=107 Participants
11 Participants
n=206 Participants
47 Participants
n=7 Participants
Race/Ethnicity, Customized
Prefer not to say
9 Participants
n=99 Participants
5 Participants
n=107 Participants
10 Participants
n=206 Participants
24 Participants
n=7 Participants
Region of Enrollment
United States
818 participants
n=99 Participants
821 participants
n=107 Participants
813 participants
n=206 Participants
2452 participants
n=7 Participants

PRIMARY outcome

Timeframe: Pre-SSI to 3-month follow-up

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.

Outcome measures

Outcome measures
Measure
Supportive Therapy SSI (ST-SSI)
n=818 Participants
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
Behavioral Activation SSI (BA-SSI)
n=821 Participants
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
Growth Mindset SSI (GM-SSI)
n=813 Participants
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
Change in Adolescent Depressive Symptom Severity
Pre-Intervention CDI-II Score
14.31 Score on a scale
Standard Deviation 4.12
14.15 Score on a scale
Standard Deviation 4.06
14.22 Score on a scale
Standard Deviation 4.13
Change in Adolescent Depressive Symptom Severity
3-month follow up CDI-II score
12.57 Score on a scale
Standard Deviation 4.97
11.47 Score on a scale
Standard Deviation 5.04
11.58 Score on a scale
Standard Deviation 5.08

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure
Supportive Therapy SSI (ST-SSI)
n=818 Participants
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
Behavioral Activation SSI (BA-SSI)
n=821 Participants
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
Growth Mindset SSI (GM-SSI)
n=813 Participants
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
Change in State Hope Scale - Pathways Subscale
Pre-intervention
3.88 Score on a scale
Standard Deviation 1.39
3.93 Score on a scale
Standard Deviation 1.40
3.96 Score on a scale
Standard Deviation 1.44
Change in State Hope Scale - Pathways Subscale
Post-intervention
5.26 Score on a scale
Standard Deviation 1.52
5.68 Score on a scale
Standard Deviation 1.43
5.50 Score on a scale
Standard Deviation 1.48
Change in State Hope Scale - Pathways Subscale
3-month follow up
4.89 Score on a scale
Standard Deviation 1.64
5.06 Score on a scale
Standard Deviation 1.63
5.17 Score on a scale
Standard Deviation 1.65

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure
Supportive Therapy SSI (ST-SSI)
n=818 Participants
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
Behavioral Activation SSI (BA-SSI)
n=821 Participants
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
Growth Mindset SSI (GM-SSI)
n=813 Participants
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
Change in Beck Hopelessness Scale - 4 Item Version
Pre-intervention
1.71 Score on a scale
Standard Deviation 0.76
1.72 Score on a scale
Standard Deviation 0.77
1.72 Score on a scale
Standard Deviation 0.76
Change in Beck Hopelessness Scale - 4 Item Version
Post-intervention
1.36 Score on a scale
Standard Deviation 0.75
1.22 Score on a scale
Standard Deviation 0.73
1.21 Score on a scale
Standard Deviation 0.72
Change in Beck Hopelessness Scale - 4 Item Version
3-month follow up
1.51 Score on a scale
Standard Deviation 0.82
1.37 Score on a scale
Standard Deviation 0.80
1.39 Score on a scale
Standard Deviation 0.83

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Supportive Therapy SSI (ST-SSI)
n=630 Participants
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
Behavioral Activation SSI (BA-SSI)
n=729 Participants
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
Growth Mindset SSI (GM-SSI)
n=653 Participants
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
Program Feedback Scale
PFS Item 3: Program was Easy to Use
4.46 score on a scale
Standard Deviation 0.64
4.42 score on a scale
Standard Deviation 0.59
4.48 score on a scale
Standard Deviation 0.64
Program Feedback Scale
PFS item 5: This program would be helpful to other kids
4.24 score on a scale
Standard Deviation 0.81
4.30 score on a scale
Standard Deviation 0.76
4.20 score on a scale
Standard Deviation 0.83
Program Feedback Scale
PFS Item 1: Enjoyed Program
3.80 score on a scale
Standard Deviation 0.79
3.93 score on a scale
Standard Deviation 0.73
3.83 score on a scale
Standard Deviation 0.77
Program Feedback Scale
PFS item 2: Understood Program
4.54 score on a scale
Standard Deviation 0.56
4.46 score on a scale
Standard Deviation 0.49
4.48 score on a scale
Standard Deviation 0.64
Program Feedback Scale
PFS Item 4: I tried my hardest on the program
4.45 score on a scale
Standard Deviation 0.65
4.42 score on a scale
Standard Deviation 0.69
4.45 score on a scale
Standard Deviation 0.67
Program Feedback Scale
PFS item 6: I would recommend this program to a friend
3.97 score on a scale
Standard Deviation 0.95
4.12 score on a scale
Standard Deviation 0.89
3.93 score on a scale
Standard Deviation 1.00
Program Feedback Scale
PFS item 7: I agree with the program's message
4.50 score on a scale
Standard Deviation 0.62
4.54 score on a scale
Standard Deviation 0.57
4.47 score on a scale
Standard Deviation 0.70

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-SSI to 3-month follow-up

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).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-SSI to 3-month follow-up

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-SSI, Immediately Post-SSI

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-SSI only

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-SSI only

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).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-SSI only

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").

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-SSI only

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-SSI

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-SSI

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.).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-SSI

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-SSI only

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-SSI to 3-month follow-up

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).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-SSI to 3-month follow-up

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-SSI only

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?

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-SSI only

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Immediately Post-SSI only

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)

Outcome measures

Outcome data not reported

Adverse Events

Supportive Therapy SSI (ST-SSI)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Behavioral Activation SSI (BA-SSI)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Growth Mindset SSI (GM-SSI)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jessica Schleider

Stony Brook University

Phone: 917-439-1872

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place