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Web-Based Interventions for Adolescent Depression

N/A
Recruiting
Led By Jessica L Schleider, PhD
Research Sponsored by Stony Brook University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Speaks English well enough to complete the smartphone-based questionnaire
Ages 11-16 (inclusive) at the time of study enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights

Study Summary

This trial will recruit 216 subjects and randomly assign them to receive one of three web-based single session interventions. The intervention will take place via secure video conferencing, and participants will complete pre- and post- intervention self-report questionnaires. Follow-up surveys will be completed at 3, 6, 12, 18, and 24 months post-intervention.

Who is the study for?
This trial is for adolescents aged 11-16 at risk of depression, who are comfortable with smartphone surveys and speak English well. They must have shown signs of depression or received treatment within the last two years. A parent or guardian must also participate.Check my eligibility
What is being tested?
The study tests three web-based single session interventions (SSIs) for adolescent depression: Supportive Therapy, Behavioral Activation, and Growth Mindset. Participants will be randomly assigned to one SSI and complete questionnaires before, immediately after, and up to 24 months post-intervention.See study design
What are the potential side effects?
Since this trial involves psychological interventions rather than medication, traditional side effects are not expected. However, participants may experience emotional discomfort when discussing personal issues during therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can complete a questionnaire in English on a smartphone.
Select...
I am between 11 and 16 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in adolescent depressive symptom severity
Secondary outcome measures
Changes in parent-reported adolescent symptom severity
Other outcome measures
Adverse Childhood Experiences (ACEs) for parent and child
Behavioral Activation for Depression Scale (BADS)-Short Form
Brief Family Assessment Measure (General Scale)
+19 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Growth Mindset SSI (GM-SSI)Experimental Treatment1 Intervention
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.
Group II: Behavioral Activation SSI (BA-SSI)Experimental Treatment1 Intervention
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.
Group III: Supportive Therapy SSI (ST-SSI)Active Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Behavioral Activation SSI
2020
N/A
~2460
Growth Mindset SSI
2020
N/A
~2460

Find a Location

Who is running the clinical trial?

Stony Brook UniversityLead Sponsor
216 Previous Clinical Trials
39,755 Total Patients Enrolled
16 Trials studying Depression
7,269 Patients Enrolled for Depression
Jessica L Schleider, PhDPrincipal InvestigatorStony Brook University
7 Previous Clinical Trials
5,821 Total Patients Enrolled
5 Trials studying Depression
5,761 Patients Enrolled for Depression

Media Library

Behavioral Activation SSI Clinical Trial Eligibility Overview. Trial Name: NCT04607902 — N/A
Depression Research Study Groups: Growth Mindset SSI (GM-SSI), Behavioral Activation SSI (BA-SSI), Supportive Therapy SSI (ST-SSI)
Depression Clinical Trial 2023: Behavioral Activation SSI Highlights & Side Effects. Trial Name: NCT04607902 — N/A
Behavioral Activation SSI 2023 Treatment Timeline for Medical Study. Trial Name: NCT04607902 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical trial consider participants who are over 55 years of age?

"According to the specifications of this trial, applicants must be adolescent, with an age range from 11 to 16. There are 192 studies that accept participants younger than 18 and 964 for those beyond 65 years old."

Answered by AI

Am I eligible to enroll in this research study?

"This research requires 216 minors, aged 11-16 (inclusive) with depression. To be eligible for enrolment in the study, participants must also have a parent or guardian involved and feel comfortable using smartphone surveys. Furthermore, they ought to exhibit either elevated risk factors of childhood depression according to parental CDI 2 reports or else have had prior treatment for their condition within two years."

Answered by AI

How many research participants are engaged in this clinical experiment?

"Affirmative. Data from clinicaltrials.gov displays that this medical trial is still recruiting participants, and was uploaded to the website on February 15th 2021 with a subsequent edit made in March of the same year. Currently, 216 volunteers are needed at one location for this study."

Answered by AI

Is there enrollment availability for this research endeavor?

"According to clinicaltrials.gov, this scientific investigation is actively seeking out volunteers for participation. This research project was initially posted on February 15th 2021 and its most recent update occurred in mid-March of the same year."

Answered by AI

Who else is applying?

What state do they live in?
New York
What site did they apply to?
Stony Brook University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+

Why did patients apply to this trial?

I have tried many different medications and nothing has worked.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How long do the visits take? Is there any compensation available to offset travel expense?
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Harnessing Network Science to Personalize Scalable Interventions for Adolescent Depression (TRACK to TREAT Phase 2)
Jessica Schleider 2021. "Harnessing Network Science to Personalize Scalable Interventions for Adolescent Depression (TRACK to TREAT Phase 2)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04607902.
All > Depression New York > Treatment Resistant Depression
~11 spots leftby Jul 2024
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