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A Single-Session Intervention for Adolescents and Young Adults With Internalizing Problems

Primary Purpose

Anxiety, Depressive Symptoms

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adolescent/Young Adult Self-Administered Web-Based Single-Session Intervention
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring depression, anxiety, growth mindset, neuroplasticity

Eligibility Criteria

13 Years - 24 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: The adolescent or young adult is between the ages of 13 and 24. The adolescent or young adult has a score above 5 on either PHQ-9 (Patient Health Questionnaire-9) or GAD-7(General Anxiety Disorder-7). The adolescent and their parent participating in the study, or the young adult can read and comprehend English. Exclusion Criteria: The adolescent or the young adult has severe current suicidal/homicidal ideation and/or self-injury requiring medical intervention as defined by the ASQ (Ask Suicide-Screening Questions). The adolescent and their parent participating in the study, or the young adult cannot read or comprehend English. The adolescent and their parent participating in the study, or the young adult cannot travel to the Baylor College of Medicine (BCM) Teen Health Clinic to receive the single-session intervention.

Sites / Locations

  • Baylor College of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adolescent/Young Adult Self-Administered Web-Based Single-Session Intervention

Arm Description

Project Personality is a 30- minute, self-administered, web-based single-session intervention that was developed to help adolescents understand what growth mindsets are and provide them with information about self-changing strategies and coping skills (Schleider & Weisz, 2019). Participants learn about how the brain functions (neuroplasticity), how personality is fluid, and read testimonials from other adolescents about how growth mindsets helped them in school and in their personal lives. Participants also have the opportunity to write notes to other youth, providing them with the advantages of using growth mindsets.

Outcomes

Primary Outcome Measures

Change in Short Mood and Feelings Questionnaire-Child (SMFQ-C)
The short version of the self-reported questionnaire that measures depressive symptoms in adolescents 12-17 years old throughout the past 2 weeks. 13 items are scored on a 0-2 scale (0= Not True; 2= True), with a total score between 0-26.
Change in Short Mood and Feelings Questionnaire-Adult (SMFQ-A)
The short version of the self-reported questionnaire that measures depressive symptoms in adults throughout the past 2 weeks. 13 items are scored on a 0-2 scale (0= Not True; 2= True), with a total score between 0-26.
Change in PROMIS (Patient-Reported Outcomes Measurement Information System) Anxiety - Child
Assesses self-reported fear, anxious misery, hyperarousal, and somatic symptoms related to arousal. 7 items are scored with a total score between 8-40.
Change in PROMIS (Patient-Reported Outcomes Measurement Information System) Anxiety - Adult
Assesses self-reported fear, anxious misery, hyperarousal, and somatic symptoms related to arousal in adults. 8 items are scored with a total score between 8-40.

Secondary Outcome Measures

Perceived Primary Control Scale
Measures perceived control over academic, social, and behavioral outcomes. Scoring for items 1,2,4,7,9,11,14,15,18,20,22, and 24 are as follows: 0= Very False, 1= Sort of False, 2= Sort of True and 3= Very True. Reverse scoring is needed for items 3,5,6,8,10,12,13,16,17,19,21, and 23 and scoring is as follows: 3= Very False, 2= Sort of False, 1= Sort of True, 0=Very True.
Perceived Secondary Control Scale
Measures the ability to adjust oneself to adverse events and how they control their subjective emotional impact. Scoring for items 1,2,5,7,10,14,17,18, and 20 are the following: 0= Very False, 1= Sort of False, 2= Sort of true and 3= Very True. Reverse scoring is needed for items 3,4,6,8,9,11,12,13,16, and 19 and the responses are as follows: 3= Very False, 2= Sort of False, 1= Sort of True, 0= Very True.
The Acceptance and Action Questionnaire-II (AAQ-II)
A scale used to evaluate a participant's (young adult) psychological flexibility. 7 items are scored on a 1-7 scale (1= never true; 5 = always true).
Avoidance and Fusion Questionnaire for Youth-8 (AFQ-8)
A scale used to evaluate a participant's (adolescent) psychological flexibility. 8 items are scored on a 0-4 scale (0= not at all true; 4 = very true).

Full Information

First Posted
March 29, 2023
Last Updated
June 5, 2023
Sponsor
Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05826392
Brief Title
A Single-Session Intervention for Adolescents and Young Adults With Internalizing Problems
Official Title
A Single-Session Intervention for Adolescents and Young Adults With Internalizing Problems
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
With the increasing number of adolescents and young adults (AYA) experiencing depression and anxiety, paired with the lack of time, access, and funding towards social services, AYA need a mental health intervention that is affordable and easily accessible. A single-session intervention (SSI), Project Personality, was developed to improve youth growth mindset and reduce symptoms of internalizing problems, such as anxiety and depression. The purpose of this pilot study is to determine the feasibility of an SSI in adolescents and young adults at a reproductive community health center.
Detailed Description
The mental health of adolescents and young adults (AYA) has greatly been impacted since the beginning of the pandemic. With the increasing number of AYA experiencing depression and anxiety, paired with the lack of time, access, and funding towards social services, AYA need a mental health intervention that is affordable and easily accessible. A single-session intervention (SSI) focused on cultivating an AYA's growth mindset has potential to overcome common barriers to care, such as cost, transportation and stigma related to psychological treatment. Furthermore, research shows having a fixed mindset correlate and can predict higher depressive and anxiety symptoms. Teaching adolescents about growth mindsets could decrease the risk of internalizing symptoms. The SSI, Project Personality, was developed to improve youth growth mindset and reduce symptoms of internalizing problems, such as anxiety and depression. The purpose of this pilot study is to determine the feasibility of an SSI in adolescents and young adults at a reproductive community health center.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depressive Symptoms
Keywords
depression, anxiety, growth mindset, neuroplasticity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Adolescents and young adults (AYA) (N=200), ages 13-24 will receive a 30-minute, web-based single-session program about growth mindset.
Masking
None (Open Label)
Masking Description
No blinding
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adolescent/Young Adult Self-Administered Web-Based Single-Session Intervention
Arm Type
Experimental
Arm Description
Project Personality is a 30- minute, self-administered, web-based single-session intervention that was developed to help adolescents understand what growth mindsets are and provide them with information about self-changing strategies and coping skills (Schleider & Weisz, 2019). Participants learn about how the brain functions (neuroplasticity), how personality is fluid, and read testimonials from other adolescents about how growth mindsets helped them in school and in their personal lives. Participants also have the opportunity to write notes to other youth, providing them with the advantages of using growth mindsets.
Intervention Type
Other
Intervention Name(s)
Adolescent/Young Adult Self-Administered Web-Based Single-Session Intervention
Other Intervention Name(s)
Project Personality
Intervention Description
Web-Based, 30-minute self-administered intervention for adolescents
Primary Outcome Measure Information:
Title
Change in Short Mood and Feelings Questionnaire-Child (SMFQ-C)
Description
The short version of the self-reported questionnaire that measures depressive symptoms in adolescents 12-17 years old throughout the past 2 weeks. 13 items are scored on a 0-2 scale (0= Not True; 2= True), with a total score between 0-26.
Time Frame
Baseline (before treatment); 2 weeks post-treatment; 2 months follow-up
Title
Change in Short Mood and Feelings Questionnaire-Adult (SMFQ-A)
Description
The short version of the self-reported questionnaire that measures depressive symptoms in adults throughout the past 2 weeks. 13 items are scored on a 0-2 scale (0= Not True; 2= True), with a total score between 0-26.
Time Frame
Baseline (before treatment); 2 weeks post-treatment; 2 months follow-up
Title
Change in PROMIS (Patient-Reported Outcomes Measurement Information System) Anxiety - Child
Description
Assesses self-reported fear, anxious misery, hyperarousal, and somatic symptoms related to arousal. 7 items are scored with a total score between 8-40.
Time Frame
Baseline (before treatment); 2 weeks post-treatment; 2 months follow-up
Title
Change in PROMIS (Patient-Reported Outcomes Measurement Information System) Anxiety - Adult
Description
Assesses self-reported fear, anxious misery, hyperarousal, and somatic symptoms related to arousal in adults. 8 items are scored with a total score between 8-40.
Time Frame
Baseline (before treatment); 2 weeks post-treatment; 2 months follow-up
Secondary Outcome Measure Information:
Title
Perceived Primary Control Scale
Description
Measures perceived control over academic, social, and behavioral outcomes. Scoring for items 1,2,4,7,9,11,14,15,18,20,22, and 24 are as follows: 0= Very False, 1= Sort of False, 2= Sort of True and 3= Very True. Reverse scoring is needed for items 3,5,6,8,10,12,13,16,17,19,21, and 23 and scoring is as follows: 3= Very False, 2= Sort of False, 1= Sort of True, 0=Very True.
Time Frame
Baseline (before treatment); 2 weeks post-treatment; 2 months follow-up
Title
Perceived Secondary Control Scale
Description
Measures the ability to adjust oneself to adverse events and how they control their subjective emotional impact. Scoring for items 1,2,5,7,10,14,17,18, and 20 are the following: 0= Very False, 1= Sort of False, 2= Sort of true and 3= Very True. Reverse scoring is needed for items 3,4,6,8,9,11,12,13,16, and 19 and the responses are as follows: 3= Very False, 2= Sort of False, 1= Sort of True, 0= Very True.
Time Frame
Baseline (before treatment); 2 weeks post-treatment; 2 months follow-up
Title
The Acceptance and Action Questionnaire-II (AAQ-II)
Description
A scale used to evaluate a participant's (young adult) psychological flexibility. 7 items are scored on a 1-7 scale (1= never true; 5 = always true).
Time Frame
Baseline (before treatment); 2 weeks post-treatment; 2 months follow-up
Title
Avoidance and Fusion Questionnaire for Youth-8 (AFQ-8)
Description
A scale used to evaluate a participant's (adolescent) psychological flexibility. 8 items are scored on a 0-4 scale (0= not at all true; 4 = very true).
Time Frame
Baseline (before treatment); 2 weeks post-treatment; 2 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The adolescent or young adult is between the ages of 13 and 24. The adolescent or young adult has a score above 5 on either PHQ-9 (Patient Health Questionnaire-9) or GAD-7(General Anxiety Disorder-7). The adolescent and their parent participating in the study, or the young adult can read and comprehend English. Exclusion Criteria: The adolescent or the young adult has severe current suicidal/homicidal ideation and/or self-injury requiring medical intervention as defined by the ASQ (Ask Suicide-Screening Questions). The adolescent and their parent participating in the study, or the young adult cannot read or comprehend English. The adolescent and their parent participating in the study, or the young adult cannot travel to the Baylor College of Medicine (BCM) Teen Health Clinic to receive the single-session intervention.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jada Thompson, MPH
Phone
(346) 286-3255
Email
jada.thompson@bcm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Storch, PhD
Phone
(713) 798-3579
Email
eric.storch@bcm.edu
Facility Information:
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Storch, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
30993499
Citation
Schleider JL, Abel MR, Weisz JR. Do Immediate Gains Predict Long-Term Symptom Change? Findings from a Randomized Trial of a Single-Session Intervention for Youth Anxiety and Depression. Child Psychiatry Hum Dev. 2019 Oct;50(5):868-881. doi: 10.1007/s10578-019-00889-2.
Results Reference
background
PubMed Identifier
32602846
Citation
Schleider JL, Dobias M, Sung J, Mumper E, Mullarkey MC. Acceptability and Utility of an Open-Access, Online Single-Session Intervention Platform for Adolescent Mental Health. JMIR Ment Health. 2020 Jun 30;7(6):e20513. doi: 10.2196/20513.
Results Reference
result
Links:
URL
http://medlineplus.gov/
Description
with keyword "anxiety" to learn more about anxiety
URL
http://medlineplus.gov/genetics/
Description
with keyword "depression" to learn more about depression

Learn more about this trial

A Single-Session Intervention for Adolescents and Young Adults With Internalizing Problems

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