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Clinical Trials/NCT06359951
NCT06359951
Enrolling By Invitation
Not Applicable

Implementation of Digital Brief, Scalable Single Session Interventions in Specialty Adolescent Care

Ann & Robert H Lurie Children's Hospital of Chicago1 site in 1 country100 target enrollmentAugust 8, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Enrollment
100
Locations
1
Primary Endpoint
Short Mood and Feelings Questionnaire (SMFQ; Messer et al., 1995)
Status
Enrolling By Invitation
Last Updated
11 months ago

Overview

Brief Summary

This study tests a suite of single-session intervention (SSI) targeting risk factors for depression and eating disorders among adolescents and young adults. Youth ages 13-25 who screen positive for depression or anxiety as a part of routine care will be offered one of three digital SSIs. Participants will complete questionnaires before the intervention, immediately after the intervention, and 3-months after completing the intervention so that the study team can investigate if Project YES leads to reductions in depression, anxiety and eating disorder symptoms.

Registry
clinicaltrials.gov
Start Date
August 8, 2024
End Date
January 31, 2026
Last Updated
11 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Anna Ros

Assistant Professor, Adolescent and Young Adult Psychologist

Ann & Robert H Lurie Children's Hospital of Chicago

Eligibility Criteria

Inclusion Criteria

  • a score \>5 on the PHQ-9 OR a score \>5 on the GAD-7
  • patient at Lurie Division of Adolescent and Young Adult Medicine
  • provider agreement that this would be an appropriate intervention
  • age between 13 and 25
  • comfort speaking and reading in either English or Spanish

Exclusion Criteria

  • inability to speak and understand English or Spanish
  • imminent risk for suicide as indicated by a "Yes" response to questions #5 on the Ask Suicide Questions (ASQ) Screener

Outcomes

Primary Outcomes

Short Mood and Feelings Questionnaire (SMFQ; Messer et al., 1995)

Time Frame: Pre-Intervention (baseline), immediately after the intervention, 12-week follow-up

A 13-item questionnaire designed to assess depressive symptoms in youth. Total scores range from 0 to 26, with higher scores indicating greater depression severity (primary outcome).

Patient Health Questionnaire-9 (PHQ-9)

Time Frame: Pre-Intervention (baseline), 12-week follow-up

A 9 item questionnaire that objectifies and assesses degree of depression severity. Total scores range from 0 to 27, with higher scores indicating greater depression severity.

Generalized Anxiety Disorder -7 (GAD-7)

Time Frame: Pre-Intervention (baseline), 12-week follow-up

A 7 item questionnaire that measures severity of anxiety, mainly in outpatients. Total scores range from 0 to 21, with higher scores indicating greater anxiety severity.

Secondary Outcomes

  • Program Feedback Scale(Immediately after the intervention)
  • Adult State Hope Scale(Pre-Intervention (baseline), immediately after the intervention, 12-week follow-up)
  • Beck Hopelessness -4(Pre-Intervention (baseline), immediately after the intervention, 12-week follow-up)
  • Dietary Restriction Screener - 2 (DRS 2)(Pre-Intervention (baseline), immediately after the intervention, 12-week follow-up)
  • Self-Hate Scale(Pre-Intervention (baseline), immediately after the intervention, 12-week follow-up)

Study Sites (1)

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