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

2026年9月23日 更新者：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).

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

80

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Jeremy Pettit, PhD
  • 電話番号：305-348-1671
  • メール：jpettit@fiu.edu

研究連絡先のバックアップ

  • 名前：Victor Buitron, PhD
  • 電話番号：305-348-9880
  • メール：vbuitron@fiu.edu

研究場所

  • アメリカ
    • Florida
      • Miami、Florida、アメリカ、33199
        • FIU Center for Children and Families
        • 主任研究者：
          • Victor Buitron, PhD
        • コンタクト：
          • Jeremy Pettit, PhD
          • 電話番号：305-348-1671
          • メール：jpettit@fiu.edu
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

12年～17年 (子)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：GO arm

Safety Planning + MATCH + GO module
行動：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.

行動：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.

行動：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.
アクティブコンパレータ：Comparison Arm

Safety Planning + MATCH
行動：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.

行動：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Interpersonal Needs Questionnaire- Burdensomenes Scale- Self-report at Mid-treatment
時間枠：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
時間枠：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
時間枠：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
時間枠：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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Interpersonal Needs Questionnaire- Burdensomenes Scale- Parent report at Mid-Treatment
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Florida International University

協力者

National Institute of Mental Health (NIMH)

捜査官

  • 主任研究者：Victor Buitron, PhD、Florida International University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2027年1月1日

一次修了 (推定)

2029年7月1日

研究の完了 (推定)

2029年7月1日

試験登録日

最初に提出

2026年9月23日

QC基準を満たした最初の提出物

2026年9月23日

最初の投稿 (実際)

2026年9月29日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月29日

QC基準を満たした最後の更新が送信されました

2026年9月23日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • IRB-26-0416
  • R33MH137300 (米国 NIH グラント/契約)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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.

IPD 共有時間枠

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.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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