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Doświadczenia życiowe młodzieży a rozwój umiejętności (LEADS)

9 października 2026 zaktualizowane przez: Rachel Vaughn-Coaxum, University of Pittsburgh

Wpływ stresujących doświadczeń życiowych na nabywanie umiejętności radzenia sobie ze stresem przez młodzież z nasilonymi objawami depresji

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).

Przegląd badań

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

88

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

    • Pennsylvania
      • Pittsburgh, Pennsylvania, Stany Zjednoczone, 15213
        • Western Psychiatric Institute and Clinic

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

12 lat do 15 lat (Dziecko)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Podstawowa nauka
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: PIERWSZE: Naprawa myśli

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."

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Cognitive Restructuring Skill Acquisition
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Biobehavioral parasympathetic regulation
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Self-reported depression symptom severity
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Główny śledczy: Rachel A Vaughn-Coaxum, Ph.D., University of Pittsburgh

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

19 maja 2021

Zakończenie podstawowe (Rzeczywisty)

10 października 2025

Ukończenie studiów (Rzeczywisty)

10 października 2025

Daty rejestracji na studia

Pierwszy przesłany

18 stycznia 2021

Pierwszy przesłany, który spełnia kryteria kontroli jakości

18 stycznia 2021

Pierwszy wysłany (Rzeczywisty)

22 stycznia 2021

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

3 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

9 października 2026

Ostatnia weryfikacja

1 października 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • STUDY20040133
  • 1K23MH123685-01 (Grant/umowa NIH USA)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

The data and protocol from this study will be shared.

Ramy czasowe udostępniania IPD

After study completion

Kryteria dostępu do udostępniania IPD

Open to public

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • ANALITYCZNY_KOD

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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