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AnxietyNCT05826392

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

A study testing Adolescent/Young Adult Self-Administered Web-Based Single-Session Intervention in people with Anxiety and Depressive Symptoms, run by Baylor College of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 13 to 24 yearsHealthy volunteers can take part
Conditions the study is for
Anxiety, Depressive Symptoms
What is being tested?
Adolescent/Young Adult Self-Administered Web-Based Single-Session Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteUnited States
Study dates
1 May 2023to 13 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 24 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Baylor College of Medicine

    Houston, Texas, 77030

Other trials in United States

About this study

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.

Read the 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.

Being tested
Adolescent/Young Adult Self-Administered Web-Based Single-Session Intervention
Keywords
depression, anxiety, growth mindset, neuroplasticity
Medical subject headings
Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adolescent/Young Adult Self-Administered Web-Based Single-Session InterventionOther

    Also called Project Personality

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

Study groups in NCT05826392
Study groupRoleWhat they receive
Adolescent/Young Adult Self-Administered Web-Based Single-Session InterventionExperimentalProject 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.
Receives: Other: Adolescent/Young Adult Self-Administered Web-Based Single-Session Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

Secondary outcomes (4)

  1. 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.

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

  2. 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.

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

  3. 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).

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

  4. 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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2023
  2. Study start1 May 2023
  3. Primary completion17 Oct 2023
  4. Study completion13 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Adolescents and young adults (AYA), ages 13-24 will receive a 30-minute, web-based single-session program about growth mindset.
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05826392
Sponsor's protocol ID
H-52397
Status last verified
Oct 2024
First submitted
29 Mar 2023
Last updated
1 Nov 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 30993499

  • 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.

    PubMed 32602846

Questions about this trial

What is this clinical trial studying?

A study testing Adolescent/Young Adult Self-Administered Web-Based Single-Session Intervention in people with Anxiety and Depressive Symptoms, run by Baylor College of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Short Mood and Feelings Questionnaire-Child (SMFQ-C) (time frame: Baseline (before treatment); 2 weeks post-treatment; 2 months follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05826392, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2024.

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