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Life Experiences in Adolescents and the Development of Skills (LEADS)

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ClinicalTrials.gov Identifier: NCT04719897
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : June 22, 2022
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Rachel Vaughn-Coaxum, University of Pittsburgh

Brief Summary:
The primary objective of this study is to assess acquisition and retention of a Cognitive Behavioral Therapy (CBT)-based "cognitive restructuring" skill, among young adolescents (12-15 years of age) with elevated depression symptoms and with population-level variability in lifetime exposure to adverse childhood experiences. This study uses a repeated-measures, longitudinal design to investigate associations between adversity exposure and learning-related cognitive control processes in the context of elevated depression (Aim 1). Adversity exposure and cognitive control will be examined as direct predictors of cognitive restructuring skill acquisition and skill retention over six-months; an indirect pathway from adversity to skill acquisition through cognitive control will also be examined (Aim 2). The study also includes exploration of key characteristics of adversity, namely the type (threat of harm versus deprivation of resources) and developmental timing of exposure, as distinct predictors of skill acquisition (exploratory Aim 3).

Condition or disease Intervention/treatment Phase
Depression in Adolescence Adverse Childhood Experiences Behavioral: FIRST: Repairing Thoughts Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Stressful Life Experiences on the Acquisition of a Coping Skill in Adolescents With Elevated Depression Symptoms
Actual Study Start Date : May 19, 2021
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : June 30, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FIRST: Repairing Thoughts Behavioral: FIRST: Repairing Thoughts
This intervention uses the Repairing Thoughts cognitive restructuring module of the FIRST (Feeling Calm, Increasing Motivation, Repairing Thoughts, Solving Problems, Trying the Opposite) cognitive behavioral therapy protocol. This psychotherapy module teaches adolescents that thoughts are linked to feelings and behaviors, and that thoughts are often "guesses" to interpreting the world around us. Adolescents are taught to notice their thoughts in real-time and evaluate the evidence that supports or contradicts the thoughts and interpretation. Adolescents are then taught strategies to re-interpret thoughts in a more realistic manner and notice changes in emotional and behavioral responses. Clinicians are provided with examples to enhance learning, and between-session practice is assigned as "homework."




Primary Outcome Measures :
  1. Cognitive Restructuring Skill Acquisition [ Time Frame: Immediately post-intervention ]
    This primary outcome measure is an idiographic interview. A study staff member will conduct the brief idiographic interview asking participants to identify a stressful or negative event that occurred in the last week that elicited a negative emotional response. Participants will be asked to describe the event in detail, and then prompted to describe how they dealt with the event. Interviewer prompts to identify thoughts will be administered as needed. Interviews will be coded of cognitive restructuring strategies and a summary score of the amount and quality of cognitive restructuring components used will be calculated. Skill acquisition is defined as the summary score at post-intervention, controlling for summary scores at pre-intervention.

  2. Cognitive Restructuring Skill Retention up to 6-months [ Time Frame: Pre-intervention up to 6-months follow-up ]
    This primary outcome measure is an idiographic interview. A study staff member will conduct the brief idiographic interview asking participants to identify a stressful or negative event that occurred in the last week that elicited a negative emotional response. Participants will be asked to describe the event in detail, and then prompted to describe how they dealt with the event. Interviewer prompts to identify thoughts will be administered as needed. Interviews will be coded of cognitive restructuring strategies and a summary score of the amount and quality of cognitive restructuring components used will be calculated. Retention of the acquired skill is defined as the summary scores at each follow-up (1-week, 3-months, and 6 months post-intervention), controlling for summary scores at post-intervention.

  3. Cognitive Restructuring Knowledge Test [ Time Frame: Immediately post-intervention ]
    This outcome measure is a two-part self-report scale. The first component asks participants to describe all the steps to the cognitive restructuring skill and assesses knowledge of each component of the cognitive restructuring skill that participants learned. A total score is generated on a scale of 0-5 with higher scores indicating greater recall. The second component includes 10 multiple-choice items presenting hypothetical social scenarios with adolescents and participants are asked to rate the most likely interpretation of the situation. Correct answers reflect a use of cognitive restructuring to interpret ambiguous situations. A total score (0-10) is generated with higher scores indicating greater knowledge. This outcome measure is adapted from an existing self-report tool known as the Skill Acquisition Measure (SAM; Lindhiem and colleagues).

  4. Biobehavioral sympathetic recovery [ Time Frame: Immediately post-intervention ]
    This primary outcome is a measure of psychophysiological response in the form of electrodermal activity (EDA), also known as skin conductance, which captures autonomic arousal in the sympathetic nervous system. Biobehavioral recovery is defined as the slope of EDA recovery directly following the use of cognitive restructuring in response to a negative emotion induction (film clip).


Secondary Outcome Measures :
  1. Biobehavioral parasympathetic regulation [ Time Frame: Immediately post-intervention ]
    This secondary outcome measure captures autonomic recovery in the form of respiratory sinus arrhythmia (RSA), a measure of parasympathetic nervous system activity. RSA levels during a task where cognitive restructuring is used in response to negative emotion induction (film clip) is compared to RSA levels during a recovery period that immediately follows. RSA recovery is defined as the percent change in average RSA levels, comparing the emotion induction period to the recovery period.


Other Outcome Measures:
  1. Self-reported depression symptom severity [ Time Frame: Pre-intervention up to 6-months post-intervention ]
    The Mood and Feelings Questionnaire (MFQ) is a self-report questionnaire assessing youth depression symptoms in the last two weeks. Items are presented on a 3-point scale with ratings of 0=Not True, 1=Sometimes, and 2=True. A total sum score (range=0-66) is generated with higher scores indicating more severe symptoms. Reliability and validity of the scale has been well-established in existing psychometric research.



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Ages Eligible for Study:   12 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Between the ages 12 years 0 months through 15 years 11 months at study enrollment
  • Have clinically elevated depression symptom severity based a cut-off score of ≥ 7 on the Patient Health Questionnaire-9, verified by clinician ratings on the Depression Rating Scale.

Exclusion Criteria:

  • Current DSM 5 diagnosis of ADHD
  • Current use of stimulants (e.g., Ritalin, Concerta, etc.)
  • Lifetime presence of a DSM-5 Psychotic or Autism Spectrum Disorder
  • Lifetime presence of a neurological or serious medical condition
  • Current DSM-5 diagnosis of substance abuse or dependence

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04719897


Contacts
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Contact: Rachel A Vaughn-Coaxum, Ph.D. 412-246-5058 rav52@pitt.edu

Locations
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United States, Pennsylvania
Western Psychiatric Institute and Clinic Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Rachel A Vaughn-Coaxum, Ph.D.    412-246-5058    rav52@pitt.edu   
Sponsors and Collaborators
University of Pittsburgh
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Rachel A Vaughn-Coaxum, Ph.D. University of Pittsburgh
Publications:
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Responsible Party: Rachel Vaughn-Coaxum, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04719897    
Other Study ID Numbers: STUDY20040133
1K23MH123685-01 ( U.S. NIH Grant/Contract )
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: June 22, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data and protocol from this study will be shared.
Supporting Materials: Study Protocol
Analytic Code
Time Frame: After study completion
Access Criteria: Open to public

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rachel Vaughn-Coaxum, University of Pittsburgh:
Depression
Adolescents
Cognitive Behavioral Therapy
Childhood Adversity
Cognitive Function
Psychophysiology
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders