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Evaluation of a Brief, Scalable Module to Mitigate Suicidal Ideation Among Youth (Phase 2)

23 września 2026 zaktualizowane przez: Florida International University

This project embeds the "Give to Others" (GO) talk therapy module in a standard, outpatient therapy protocol to demonstrate target engagement in the context of ongoing clinical care and testing the ability of the GO module to engage the target in a rigorous randomized controlled trial (RCT) of the intervention. We will target perceived burdensomeness (PB) among 80 clinic-referred youths (ages 12-17) who experience subacute suicidal ideation (SI; i.e., positive suicide risk screen; stable safety status).

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

Youths will be recruited from the FIU Center for Children and Families (CCF) waitlist and the community at large, and will be randomized to one of the following 2 arms: a 12-session talk therapy and suicide risk management condition (control arm); and a 12-session therapy and suicide risk management condition plus the GO module (active arm). We hypothesize that youths receiving the GO module will have lower levels of PB and burden-related interpretation bias at mid-treatment and post-treatment compared with youths who receive the control arm. We also hypothesize that youths receiving the GO module will have lower levels of PB and burden-related interpretation bias at midtreatment and posttreatment compared to pre-treatment levels.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

80

Faza

  • Nie dotyczy

Kontakty i lokalizacje

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

Kontakt w sprawie studiów

  • Nazwa: Jeremy Pettit, PhD
  • Numer telefonu: 305-348-1671
  • E-mail: jpettit@fiu.edu

Kopia zapasowa kontaktu do badania

  • Nazwa: Victor Buitron, PhD
  • Numer telefonu: 305-348-9880
  • E-mail: vbuitron@fiu.edu

Lokalizacje studiów

  • Stany Zjednoczone
    • Florida
      • Miami, Florida, Stany Zjednoczone, 33199
        • FIU Center for Children and Families
        • Główny śledczy:
          • Victor Buitron, PhD
        • Kontakt:
        • Kontakt:

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 17 lat (Dziecko)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria

Adolescents must:

  • be between ages 12 and 17 years
  • score at or above the clinical cutoff on the Revised Child Anxiety and Depression Scale
  • score at or above 4 on the Interpersonal Needs Questionnaire- Burdensomeness Scale
  • have a positive screen for suicide risk (i.e., endorsement of suicidal ideation via self-report)
  • be fluent in English and have available a parent who is fluent in English or Spanish

Exclusion Criteria

For adolescents to be excluded, they must:

  • have cognitive impairment or developmental delay which does not allow for the completion of basic study procedures (i.e., reading and filling out questionnaires; talking to a clinician)
  • show imminent risk or a history of hurting themselves or others requiring intensive and restrictive services
  • be involved currently in a psychosocial treatment

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: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: GO arm

Safety Planning + MATCH + GO module
Behawioralne: Safety Planning

Safety planning is a standard suicide risk assessment and management protocol. This protocol involves determining level of risk based on current and prior suicidal thoughts and behavior, and then collaborative planning with youth and families for self-monitoring, self-regulation, help seeking, and suicide means restriction.

Behawioralne: Give to Others (GO) Module

The GO Module is a brief cognitive behavioral intervention targeting youth burden-related beliefs. It consists of one primary session and brief follow-up.

Behawioralne: MATCH (Modular Approach to Therapy for Children) - Anxiety and Depression Modules

The MATCH Anxiety and Depression modules involve a transdiagnostic protocol that adapts to individual clinical needs for teens experiencing internalizing symptoms. Participants receive weekly cognitive-behavioral therapy sessions guided by manualized decision flowcharts to sequence treatment strategies.
Aktywny komparator: Comparison Arm

Safety Planning + MATCH
Behawioralne: Safety Planning

Safety planning is a standard suicide risk assessment and management protocol. This protocol involves determining level of risk based on current and prior suicidal thoughts and behavior, and then collaborative planning with youth and families for self-monitoring, self-regulation, help seeking, and suicide means restriction.

Behawioralne: MATCH (Modular Approach to Therapy for Children) - Anxiety and Depression Modules

The MATCH Anxiety and Depression modules involve a transdiagnostic protocol that adapts to individual clinical needs for teens experiencing internalizing symptoms. Participants receive weekly cognitive-behavioral therapy sessions guided by manualized decision flowcharts to sequence treatment strategies.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Interpersonal Needs Questionnaire- Burdensomenes Scale- Self-report at Mid-treatment
Ramy czasowe: From pre-treatment to mid-treatment (within one week of completing the assigned intervention at the midpoint of CBT)

5-item youth self-ratings on perceived burdensomeness over the past week. Each item is scored 1-7 (1 = not at all true for me; 7 = very true for me), yielding a total between 5 and 35. Higher scores indicate higher levels of perceived burdensomeness (worse outcome).
From pre-treatment to mid-treatment (within one week of completing the assigned intervention at the midpoint of CBT)
Suicide Risk and Ideation Scale for Kids (S-RISK) - Child Report at Mid-Treatment
Ramy czasowe: From pre-treatment to mid-treatment (within one week of completing the assigned intervention at the midpoint of CBT)

The S-RISK measures the severity and intensity of suicidal thoughts and capability via 20 items. Higher scores indicate higher severity of suicide risk.
From pre-treatment to mid-treatment (within one week of completing the assigned intervention at the midpoint of CBT)
Interpersonal Needs Questionnaire- Burdensomenes Scale- Self-report at Post-treatment
Ramy czasowe: From pre-treatment to post-treatment (within one week of completing the final CBT session)

5-item youth self-ratings on perceived burdensomeness over the past week. Each item is scored 1-7 (1 = not at all true for me; 7 = very true for me), yielding a total between 5 and 35. Higher scores indicate higher levels of perceived burdensomeness (worse outcome).
From pre-treatment to post-treatment (within one week of completing the final CBT session)
Suicide Risk and Ideation Scale for Kids (S-RISK) - Child Report at Post-Treatment
Ramy czasowe: From pre-treatment to post-treatment (within one week of completing the final CBT session)

The S-RISK measures the severity and intensity of suicidal thoughts and capability via 20 items. Higher scores indicate higher severity of suicide risk.
From pre-treatment to post-treatment (within one week of completing the final CBT session)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Interpersonal Needs Questionnaire- Burdensomenes Scale- Parent report at Mid-Treatment
Ramy czasowe: From pre-treatment to mid-treatment (within one week of completing the assigned intervention at the midpoint of CBT)

5-item parent ratings on youth perceived burdensomeness over the past week. Each item is scored 1-7 (1 = not at all true for me; 7 = very true for me), yielding a total between 5 and 35. Higher scores indicate higher levels of perceived burdensomeness (worse outcome).
From pre-treatment to mid-treatment (within one week of completing the assigned intervention at the midpoint of CBT)
Sentence Completion Task- Liability Index at Mid-Treatment
Ramy czasowe: From pre-treatment to mid-treatment (within one week of completing the assigned intervention at the midpoint of CBT)

28-item youth completed task assessing burden-related interpretation bias. Participants read 28 sentences indicative of posing a liability on others and select negatively- or positively-valenced words to complete each sentence. Each item is scored 0 or 1, yielding a total score between 0 and 28. Higher scores indicate higher levels of burden interpretation bias (worse outcome).
From pre-treatment to mid-treatment (within one week of completing the assigned intervention at the midpoint of CBT)
Momentary Perceived Burdensomeness (mPB) Scale at Mid-Treatment
Ramy czasowe: From pre-treatment to mid-treatment (within one week of completing the assigned intervention at the midpoint of CBT)

The mPB scale was developed to capture real-time states of perceived burdensomeness (Lühr et al., 2026). mPB includes two self-report items rated 1 to 5 with higher scores indicating higher levels of burdensomeness.
From pre-treatment to mid-treatment (within one week of completing the assigned intervention at the midpoint of CBT)
Interpersonal Needs Questionnaire- Burdensomenes Scale- Parent report at Post-Treatment
Ramy czasowe: From pre-treatment to post-treatment (within one week of completing the final CBT session)

5-item parent ratings on youth perceived burdensomeness over the past week. Each item is scored 1-7 (1 = not at all true for me; 7 = very true for me), yielding a total between 5 and 35. Higher scores indicate higher levels of perceived burdensomeness (worse outcome).
From pre-treatment to post-treatment (within one week of completing the final CBT session)
Sentence Completion Task- Liability Index at Post-Treatment
Ramy czasowe: From pre-treatment to post-treatment (within one week of completing the final CBT session)

28-item youth completed task assessing burden-related interpretation bias. Participants read 28 sentences indicative of posing a liability on others and select negatively- or positively-valenced words to complete each sentence. Each item is scored 0 or 1, yielding a total score between 0 and 28. Higher scores indicate higher levels of burden interpretation bias (worse outcome).
From pre-treatment to post-treatment (within one week of completing the final CBT session)
Momentary Perceived Burdensomeness (mPB) Scale at Post-Treatment
Ramy czasowe: From pre-treatment to post-treatment (within one week of completing the final CBT session)

The mPB scale was developed to capture real-time states of perceived burdensomeness (Lühr et al., 2026). mPB includes two self-report items rated 1 to 5 with higher scores indicating higher levels of burdensomeness.
From pre-treatment to post-treatment (within one week of completing the final CBT session)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Florida International University

Współpracownicy

National Institute of Mental Health (NIMH)

Śledczy

  • Główny śledczy: Victor Buitron, PhD, Florida International University

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 (Szacowany)

1 stycznia 2027

Zakończenie podstawowe (Szacowany)

1 lipca 2029

Ukończenie studiów (Szacowany)

1 lipca 2029

Daty rejestracji na studia

Pierwszy przesłany

23 września 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

23 września 2026

Pierwszy wysłany (Rzeczywisty)

29 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

29 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

23 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • IRB-26-0416
  • R33MH137300 (Grant/umowa NIH USA)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

We will submit deidentified raw data to the National Institute of Mental Health (NIMH) Data Archive (NDA). The NDA is a data repository run by the NIMH that allows researchers studying mental health to collect and share deidentified information with each other. Our local data files will be coded, meaning we can track data back to subjects via a master key. However, we will upload de-identified electronic raw data collected from questionnaires and interviews to the NDA.

Ramy czasowe udostępniania IPD

The scientific community will have access to data when the award ends. NDA will make decisions about how long to preserve the data, but that data archive has not deleted any deposited data up to now.

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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