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Completed

NCT Number: NCT06359951

Implementation of Project YES in Ambulatory Adolescent & Young Adult Medicine

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, as well as eating disorder symptoms.

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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Eating Disorders Feeding and Eating Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

13 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Project YES

Behavioral

Digital SSI

Primary outcomes

  1. 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).

  2. 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.

  3. 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

  1. Dietary Restriction Screener - 2 (DRS 2)

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

    This is a a single-item screener designed to identify individuals recently engaging in problematic restriction. The single item is "Have there been any times within the past month when you have eaten in this manner because you were concerned about your body shape and/or weight?" and has participants respond with a yes or a no.

  2. Adult State Hope Scale

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

    The 3-item State Hope Scale is a a dispositional self-report measure of agency. This scale can range from 3 to 24, with higher scores indicating higher levels of agency thinking.

  3. Self-Hate Scale

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

    The 7-item Self-Hate Scale is a brief, psychometrically valid measure of self-hate. Total scores are calculated as the mean of all items and scores are coded such that higher ratings indicate higher levels of self-hate (range 1-7).

  4. Beck Hopelessness -4

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

    This four-item scale measures major aspects of hopelessness using true/false questions examining the respondent's attitude for the past week. This scale ranges from 0-4 such that higher scores reflect higher levels of hopelessness.

  5. Program Feedback Scale

    Time frame: Immediately after the intervention

    The program feedback scale asks participants to rate agreement with seven statements indicating perceived acceptability and feasibility of their selected SSI (eg, "I enjoyed the program") on a 5-point Likert scale (1="really disagree"; 5="totally agree"). Means and standard deviations are calculated for each item (range 0-7), with a mean of 3.5 for each item indicating acceptability and feasibility.

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Collaborators

  • American Psychological Association (APA)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 11, 2024
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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