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Esperienze di vita negli adolescenti e lo sviluppo delle abilità (LEADS)

9 ottobre 2026 aggiornato da: Rachel Vaughn-Coaxum, University of Pittsburgh

Effetti di esperienze di vita stressanti sull'acquisizione di capacità di coping in adolescenti con sintomi depressivi elevati

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).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

ASSESSMENT: With verbal permission from the parent, both the interested parent and adolescent will complete an eligibility screener over the phone. The eligibility screener includes demographic information, psychiatric history, and current depression symptoms (self-report Patient Health Questionnaire-9, and the parent-report Children's Depression Inventory-2) to confirm that interested families meet initial inclusion criteria.

Baseline Assessment. A baseline assessment will be scheduled with all families. Informed consent and assent will be obtained prior to the start of any baseline assessment activities. A diagnostic interview (K-SADS-P/L) will be completed by a trained study staff member with each adolescent and their consenting parent. Diagnoses will be based on consensus ratings between adolescents and parents. Study staff will also administer the pediatric Columbia Suicide Severity Rating Scale, the Depression Rating Scale (embedded in K-SADS-P/L), and the Childhood Trauma Questionnaire.

The Wechsler Abbreviated Scale for Intelligence-II (WASI-II), the Cambridge Neuropsychological Test Automated Battery (CANTAB), and computerized tasks described in the outcome measures will be administered by a study staff member.

Self-report questionnaires will be administered to the parents and adolescents assessing peer victimization, community violence exposure, child and family demographics, stressful life events, food security, neglectful behaviors, social and cognitive stimulation during early childhood, discrimination, pubertal development, sleep behaviors, depression symptoms, and parent-child relationship quality.

Final study eligibility will be confirmed based on interviews and the WASI-II.

EXPERIMENTAL SKILL LEARNING AND ASSESSMENT Approximately one week following the baseline assessment (up to four weeks to allow for any scheduling difficulties) all participants will complete a 60-minute skill learning session. Prior to the experimental skills learning procedures, a study staff member will complete a brief (10-minute) interview with participants asking them to identify and describe a stressful event or interpersonal interaction from the past week. Participants will be asked to describe in detail how they coped with the event. Prompts will be given to elicit more detail when necessary. The purpose of the interview is to assess baseline cognitive restructuring skill use. After completing the interview, a trained study clinician will deliver the "Repairing Thoughts" skills module teaching cognitive restructuring from the "FIRST: Principal Based Approach to Evidence-based Psychotherapy" manual to the adolescent. The interview and the skills module may be audio and/or video recorded. Participants will be asked to practice their skill at home each day after the visit for the next week, and they will be sent an electronic daily survey to indicate whether they practiced.

Participants will be asked to complete a 90-minute, second session, one week later (up to three weeks to allow for any scheduling difficulties) to review the skill and practice in-vivo with the study clinician. After review and practice with the study clinician, a study staff member will meet with the adolescent participant to repeat the interview conducted during the first session.

As a part of this second skill learning session, a study staff member will introduce an in-vivo cognitive restructuring task to assess acquisition of the skill. Prior to the start of the in-vivo skill, resting-state continuous measurement of electrodermal activity (EDA; skin conductance), electrocardiogram (ECG), and respiration (RSP) will be collected at baseline. Study staff members (or the parent, if the adolescent prefers) will attach the electrodes and wireless transmitters (attached by velcro band to participants wrist and torso, on the exterior surface of clothing). After a baseline resting period, participants will be shown four brief film clips from movies or TV shows that have been extensively tested for reliably evoking negative emotions. Participants will be instructed to "watch" two clips, and to use cognitive restructuring to "reappraise" and reduce their emotional response during the remaining two clips (order counter-balanced). Continuous EDA, ECG, and RSP measurement will span the duration of the lab task and a three-minute recovery period that follows. The difference in physiological recovery between the "watch" and "reappraise" clips indexes cognitive restructuring ability.

Skill Retention Assessment. Participants will be sent online self-report surveys via the secure Qualtrics platform at 1-week, 3-months and 6-months follow-up. The interview conducted at pre- and post-skill learning sessions will also be repeated via phone at these timepoints. At 1-week follow-up, the online survey is a memory test for the cognitive restructuring skill. At 3-months follow-up and 6-months follow-up, self-report surveys will assess depression symptom levels, any psychotherapy or psychotropic medication services initiated since the last in-person visit, and the memory test for the cognitive restructuring skill. Adolescent participants will also re-complete the interview from the last in-person visit, conducted over the phone with study staff at all three follow-ups.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

88

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Pennsylvania
      • Pittsburgh, Pennsylvania, Stati Uniti, 15213
        • Western Psychiatric Institute and Clinic

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 12 anni a 15 anni (Bambino)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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:

  • 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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: PRIMO: Riparare i Pensieri

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."

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Cognitive Restructuring Skill Acquisition
Lasso di tempo: 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.

Immediately post-intervention
Cognitive Restructuring Skill Retention up to 6-months
Lasso di tempo: 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.

Pre-intervention up to 6-months follow-up
Cognitive Restructuring Knowledge Test
Lasso di tempo: 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).

Immediately post-intervention
Biobehavioral sympathetic recovery
Lasso di tempo: 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).

Immediately post-intervention

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Biobehavioral parasympathetic regulation
Lasso di tempo: 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.

Immediately post-intervention

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Self-reported depression symptom severity
Lasso di tempo: 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.

Pre-intervention up to 6-months post-intervention

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Collaboratori

Investigatori

  • Investigatore principale: Rachel A Vaughn-Coaxum, Ph.D., University of Pittsburgh

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

19 maggio 2021

Completamento primario (Effettivo)

10 ottobre 2025

Completamento dello studio (Effettivo)

10 ottobre 2025

Date di iscrizione allo studio

Primo inviato

18 gennaio 2021

Primo inviato che soddisfa i criteri di controllo qualità

18 gennaio 2021

Primo Inserito (Effettivo)

22 gennaio 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • STUDY20040133
  • 1K23MH123685-01 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

The data and protocol from this study will be shared.

Periodo di condivisione IPD

After study completion

Criteri di accesso alla condivisione IPD

Open to public

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • CODICE_ANALITICO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .