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

October 31, 2024 updated by: Eric A Storch, Baylor College of Medicine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adolescent/Young Adult Self-Administered Web-Based Single-Session Intervention
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.
Other: Adolescent/Young Adult Self-Administered Web-Based Single-Session Intervention
Web-Based, 30-minute self-administered intervention for adolescents
Other Names:
  • Project Personality

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Short Mood and Feelings Questionnaire-Child (SMFQ-C)
Time Frame: Baseline (before treatment); 2 weeks post-treatment; 2 months follow-up
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.
Baseline (before treatment); 2 weeks post-treatment; 2 months follow-up
Change in Short Mood and Feelings Questionnaire-Adult (SMFQ-A)
Time Frame: Baseline (before treatment); 2 weeks post-treatment; 2 months follow-up
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.
Baseline (before treatment); 2 weeks post-treatment; 2 months follow-up
Change in PROMIS (Patient-Reported Outcomes Measurement Information System) Anxiety - Child
Time Frame: Baseline (before treatment); 2 weeks post-treatment; 2 months follow-up
Assesses self-reported fear, anxious misery, hyperarousal, and somatic symptoms related to arousal. 7 items are scored with a total score between 8-40.
Baseline (before treatment); 2 weeks post-treatment; 2 months follow-up
Change in PROMIS (Patient-Reported Outcomes Measurement Information System) Anxiety - Adult
Time Frame: Baseline (before treatment); 2 weeks post-treatment; 2 months follow-up
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.
Baseline (before treatment); 2 weeks post-treatment; 2 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived Primary Control Scale
Time Frame: Baseline (before treatment); 2 weeks post-treatment; 2 months follow-up
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.
Baseline (before treatment); 2 weeks post-treatment; 2 months follow-up
Perceived Secondary Control Scale
Time Frame: Baseline (before treatment); 2 weeks post-treatment; 2 months follow-up
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.
Baseline (before treatment); 2 weeks post-treatment; 2 months follow-up
The Acceptance and Action Questionnaire-II (AAQ-II)
Time Frame: Baseline (before treatment); 2 weeks post-treatment; 2 months follow-up
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).
Baseline (before treatment); 2 weeks post-treatment; 2 months follow-up
Avoidance and Fusion Questionnaire for Youth-8 (AFQ-8)
Time Frame: Baseline (before treatment); 2 weeks post-treatment; 2 months follow-up
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).
Baseline (before treatment); 2 weeks post-treatment; 2 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Actual)

October 17, 2023

Study Completion (Actual)

August 13, 2024

Study Registration Dates

First Submitted

March 29, 2023

First Submitted That Met QC Criteria

April 21, 2023

First Posted (Actual)

April 24, 2023

Study Record Updates

Last Update Posted (Estimated)

November 1, 2024

Last Update Submitted That Met QC Criteria

October 31, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-52397

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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