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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 17, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 13, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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