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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05826392
• Other study ID #: H-52397
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Depressive Symptoms

Intervention

Other:
• Adolescent/Young Adult Self-Administered Web-Based Single-Session Intervention
Web-Based, 30-minute self-administered intervention for adolescents

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Perceived Primary Control Scale	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
Secondary	Perceived Secondary Control Scale	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
Secondary	The Acceptance and Action Questionnaire-II (AAQ-II)	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
Secondary	Avoidance and Fusion Questionnaire for Youth-8 (AFQ-8)	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

External Links

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