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Completed

NCT Number: NCT05826392

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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Depressive Symptoms Mental Disorders

Age range

13 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor College of Medicine

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

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

Other names: Project Personality

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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).

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Apr 24, 2023
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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