Life Experiences in Adolescents and the Development of Skills

NCT04719897 | Completed DMC

• 2 other identifiers: STUDY200401331K23MH123685-01
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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).

Conditions

Depression in Adolescence; Adverse Childhood Experiences

Keywords

Depression; Adolescents; Cognitive Behavioral Therapy; Childhood Adversity; Cognitive Function; Psychophysiology

Outcome Measures

Primary Outcomes (4)

• Cognitive Restructuring Skill Acquisition

  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.

  Immediately post-intervention

• Cognitive Restructuring Skill Retention up to 6-months

  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.

  Pre-intervention up to 6-months follow-up

• Cognitive Restructuring Knowledge Test

  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).

  Immediately post-intervention

• Biobehavioral sympathetic recovery

  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).

  Immediately post-intervention

Secondary Outcomes (1)

• Biobehavioral parasympathetic regulation

  Immediately post-intervention

Other Outcomes (1)

• Self-reported depression symptom severity

  Pre-intervention up to 6-months post-intervention

Study Arms (1)

FIRST: Repairing Thoughts

EXPERIMENTAL

Behavioral: FIRST: Repairing Thoughts

Interventions

FIRST: Repairing Thoughts BEHAVIORAL

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."

FIRST: Repairing Thoughts

Eligibility Criteria

• Age: 12 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

• Weisz, J. R., & Bearman, S. K. (2020). Principle-Guided Psychotherapy for Children and Adolescents: The FIRST Program for Behavioral and Emotional Problems. Guilford Press.

  BACKGROUND

• Gilman TL, Shaheen R, Nylocks KM, Halachoff D, Chapman J, Flynn JJ, Matt LM, Coifman KG. A film set for the elicitation of emotion in research: A comprehensive catalog derived from four decades of investigation. Behav Res Methods. 2017 Dec;49(6):2061-2082. doi: 10.3758/s13428-016-0842-x.

  PMID: 28078572 BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Rachel A Vaughn-Coaxum, Ph.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: January 22, 2021
• Study Start: May 19, 2021
• Primary Completion: October 10, 2025
• Study Completion: October 10, 2025
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: After study completion
• Access Criteria: Open to public

Locations

US (1)