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

NCT05826392 | Completed

• 1 other identifier: H-52397
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Depressive Symptoms

Keywords

depression; anxiety; growth mindset; neuroplasticity

Outcome Measures

Primary Outcomes (4)

• 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.

  Baseline (before treatment); 2 weeks post-treatment; 2 months follow-up

• 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.

  Baseline (before treatment); 2 weeks post-treatment; 2 months follow-up

• 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.

  Baseline (before treatment); 2 weeks post-treatment; 2 months follow-up

• 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.

  Baseline (before treatment); 2 weeks post-treatment; 2 months follow-up

Secondary Outcomes (4)

• Perceived Primary Control Scale

  Baseline (before treatment); 2 weeks post-treatment; 2 months follow-up

• Perceived Secondary Control Scale

  Baseline (before treatment); 2 weeks post-treatment; 2 months follow-up

• The Acceptance and Action Questionnaire-II (AAQ-II)

  Baseline (before treatment); 2 weeks post-treatment; 2 months follow-up

• Avoidance and Fusion Questionnaire for Youth-8 (AFQ-8)

  Baseline (before treatment); 2 weeks post-treatment; 2 months follow-up

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

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

Web-Based, 30-minute self-administered intervention for adolescents

Also known as: Project Personality

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

Eligibility Criteria

• Age: 13 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (2)

• 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.

  PMID: 30993499 BACKGROUND

• 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.

  PMID: 32602846 BACKGROUND

Related Links

• with keyword "anxiety" to learn more about anxiety
• with keyword "depression" to learn more about depression

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No blinding
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Adolescents and young adults (AYA), ages 13-24 will receive a 30-minute, web-based single-session program about growth mindset.

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 24, 2023
• Study Start: May 1, 2023
• Primary Completion: October 17, 2023
• Study Completion: August 13, 2024
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)