Harnessing Network Science to Personalize Scalable Interventions for Adolescent Depression (TRACK to TREAT Phase 2)

NCT04607902 | Unknown

• 1 other identifier: IRB2019-00382
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in adolescent depressive symptom severity

  The Children's Depression Inventory (CDI) 2 - short form (CDI-SF) is a reliable, valid measure of youth-reported depression severity, normed for youth age and sex and yielding raw and T scores.

  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

Secondary Outcomes (1)

• Changes in parent-reported adolescent symptom severity

  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

Other Outcomes (22)

• Demographics

  Pre-intervention only (sex, race); Pre-intervention, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up (age, gender identity, mental health treatment history)

• Pubertal development

  Pre-intervention only

• Adverse Childhood Experiences (ACEs) for parent and child

  Pre-intervention only

Study Arms (3)

Supportive Therapy SSI (ST-SSI)

ACTIVE COMPARATOR

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.

Behavioral: Supportive Therapy SSI

Behavioral Activation SSI (BA-SSI)

EXPERIMENTAL

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: Behavioral Activation SSI

Growth Mindset SSI (GM-SSI)

EXPERIMENTAL

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.

Behavioral: Growth Mindset SSI

Interventions

Supportive Therapy SSI BEHAVIORAL

Online, 30-minute self-administered program for youth

Also known as: Sharing Feelings SSI, ST-SSI

Supportive Therapy SSI (ST-SSI)

Behavioral Activation SSI BEHAVIORAL

Online, 30-minute self-administered program for youth

Also known as: Activate Action, BA-SSI

Behavioral Activation SSI (BA-SSI)

Growth Mindset SSI BEHAVIORAL

Online, 30-minute self-administered program for youth

Also known as: Project Personality, GM-SSI

Growth Mindset SSI (GM-SSI)

Eligibility Criteria

• Age: 11 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

Stony Brook University

Stony Brook, New York, 11790, United States

RECRUITING

MeSH Terms

Conditions

Depression; Mood Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Jessica L Schleider, PhD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica L Schleider, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychology

Model Details: Participants will be randomized (via a random number generator in Qualtrics, double-masking the randomization procedure) to one of the conditions.

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: October 29, 2020
• Study Start: February 15, 2021
• Primary Completion: July 1, 2024
• Study Completion: August 1, 2024
• Last Updated: March 17, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: After study completion
• Access Criteria: Open to public

Locations

US (1)