Recruiting

Personalized Interventions

Sponsor:

Stony Brook University

Code:

NCT04607902

Conditions

Depression

Eligibility Criteria

Sex: All

Age: 11 - 16

Healthy Volunteers: Not accepted

Interventions

Supportive Therapy SSI

Behavioral Activation SSI

Growth Mindset SSI

Study Details

Brief summary:

We will recruit 216 subjects meeting the eligibility criteria. After completing a baseline battery session via secure video conferencing and 3-week phone survey period, adolescents will be randomly assigned to receive 1 of 3 web-based single session interventions (SSIs) at a second secure video conference session. This second session for the intervention will take place within 2-3 weeks after the phone survey period. Immediately pre- and post-SSI, adolescents will complete a limited number of self-report questionnaires to index shifts in proximal outcomes. Participants, both adult and youth, will complete additional follow-up questionnaires 3, 6, 12, 18, and 24 months post-intervention. Participants will complete the intervention, including the pre- and post- SSI questionnaires, and follow-up surveys on their own.

Conditions

Depression

Study ID

NCT04607902

Start date

Feb 15, 2021

Status verified date

Mar, 2021

Completion date

Aug, 2024

Anticipated

Primary completion date

Jul, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 16

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Ages 11-16 (inclusive) at the time of study enrollment
  • Has one parent or legal guardian willing to participate in the study
  • Speaks English well enough to complete the smartphone-based questionnaire
  • Comfort with smartphone-based surveys
  • Indication of elevated risk for youth depression, one of two ways (or both ways): (a) elevations in depressive symptoms, at least 80th percentile or higher, based on parent-report CDI 2; (b) received treatment for depression within the previous 2 years

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
  • Provide responses of fewer than 3 words to writing prompts that ask for at least 2 sentences or more

Study Design

Enrollment

216 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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.

experimental: 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.

experimental: 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.

Interventions

Supportive Therapy SSI

Online, 30-minute self-administered program for youth

Behavioral Activation SSI

Online, 30-minute self-administered program for youth

Growth Mindset SSI

Online, 30-minute self-administered program for youth

Primary outcome measure

  • Change in adolescent depressive symptom severity [ Time Frame: Pre-intervention to 3-month follow-up; Pre-intervention to 6-month follow-up; Pre-intervention to 12-month follow-up; Pre-intervention to 18-month follow-up; Pre-intervention to 24-month follow-up ]

Central Contacts and Locations

Central contacts

Jessica L Schleider, PhD

631-632-4131jessica.schleider@stonybrook.edu

Locations

Stony Brook University

Recruiting

Stony Brook, New York, United States, 11790

Contacts

Jessica L Schleider, PhD

631-632-4131jessica.schleider@stonybrook.edu

More Information

Sponsor

Stony Brook University

Last update posted

Mar 17, 2021

Last verified

Mar, 2021

Keywords

  • Single Session Intervention
  • Online Intervention
  • Adolescent Depression
  • Mood Disorders
  • Experience Sampling Method

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stony Brook University on 2021-03-17.