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

Sponsor

Baylor College of Medicine (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05826392

Collaborator

(none)

200

Enrollment

Location

Arm

Anticipated Duration (Months)

49.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Depressive Symptoms	Other: Adolescent/Young Adult Self-Administered Web-Based Single-Session Intervention	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention 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.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

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in Short Mood and Feelings Questionnaire-Child (SMFQ-C) [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.
Change in Short Mood and Feelings Questionnaire-Adult (SMFQ-A) [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.
Change in PROMIS (Patient-Reported Outcomes Measurement Information System) Anxiety - Child [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.
Change in PROMIS (Patient-Reported Outcomes Measurement Information System) Anxiety - Adult [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.

Secondary Outcome Measures

Perceived Primary Control Scale [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.
Perceived Secondary Control Scale [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.
The Acceptance and Action Questionnaire-II (AAQ-II) [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).
Avoidance and Fusion Questionnaire for Youth-8 (AFQ-8) [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 24 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.