Engaging Family Members During Early SUD Treatment: A Hybrid Trial
The goal of this study is a fractional factorial optimization trial to optimize engagement in a CRAFT program for family members with loved ones in outpatient treatment for a substance use disorder.
This study aims to identify family engagement strategies that are feasible, acceptable, and appropriate and effective in increasing family member initiation with CRAFT. Participants will complete an iterative, online process where they will evaluate and rank different engagement strategies to identify the most optimal in increasing engagement and then participate in an optimization trial to identify which strategies were most effective in increasing family member engagement.
調査の概要
状態
条件
詳細な説明
Family members (FMs) of people with substance use disorder (SUD)-including biological, extended, or chosen family-face chronic stress and are at high risk for mental and physical health problems. The impact is worsened by stigma, guilt, shame, and self-blame that often accompany a loved one's substance use, leading to social isolation and uncertainty about how to support recovery. Although FMs are motivated to help with treatment navigation, many do not seek support for themselves. Programs like Community Reinforcement and Family Training (CRAFT) can support FMs and provide tools to improve their own lives while assisting their loved one's recovery. While CRAFT is well-established in community settings for increasing a family member's initiation into treatment, its applicability in clinical SUD settings is less clear. It remains unknown whether CRAFT can enhance patient treatment retention in clinical settings and whether FMs who might not seek care would participate.
To advance the science of engaging and supporting families impacted by SUD, investigators will (1) Conduct an iterative online process with FMs and clinic staff to identify potential family engagement strategies that community health centers (CHCs) can deliver that are effective, feasible, acceptable, and appropriate, and (2) Test those strategies using a fractional factorial trial.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Kat Nameth, MS
- 電話番号：650-542-9699
- メール：knameth@stanford.edu
研究連絡先のバックアップ
- 名前：Kirsten Becker, MPH
- 電話番号：(866) 697-5620
- メール：becker@rand.org
研究場所
-
-
California
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San Diego、California、アメリカ、92012
- Family Health Centers of San Diego
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コンタクト：
- Joe Sepulveda, MD
- 電話番号：(619) 515-2300
- メール：joes@fhcsd.org
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
FAMILY MEMBERS:
Inclusion Criteria:
- 18 years old or older
- A parent, child, sibling, spouse/romantic partner, or other adult supporting a loved one who initiated SUD treatment in past 3 months
- Cohabitating with their loved one
- In frequent contact (in-person or virtual) with their loved one (at least 3x/week)
- Not worried about potential physical harm from their loved one
- Report no illicit drug use in the past year
PATIENTS:
Inclusion Criteria:
- 18 years old or older
- In frequent contact with a family member (at least 3x/week) that they cohabitate with
- Have initiated substance use treatment in past 3 months
CLINIC PROVIDERS:
Inclusion Criteria:
- Counselor/Clinician providing care at our partner clinic for SUD
Exclusion Criteria (ALL):
- Does not have capacity to consent (e.g., severe cognitive impairment, in active psychosis, or developmental disabilities)
- Does not understand English fluently
研究計画
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：階乗代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Aim 2: Arm 1
All 4 Engagement Strategies
|
Engagement Strategy
Engagement Strategy
Engagement Strategy
Engagement Strategy
|
|
アクティブコンパレータ：Aim 2: Arm 2
Strategies 1-3
|
Engagement Strategy
Engagement Strategy
Engagement Strategy
|
|
アクティブコンパレータ：Aim 2: Arm 3
Strategies 1-2
|
Engagement Strategy
Engagement Strategy
|
|
アクティブコンパレータ：Aim 2: Arm 4
Strategies 2-4
|
Engagement Strategy
Engagement Strategy
Engagement Strategy
|
|
アクティブコンパレータ：Aim 2: Arm 5
Strategies 3-4
|
Engagement Strategy
Engagement Strategy
|
|
アクティブコンパレータ：Aim 2: Arm 6
Strategies 1 & 3
|
Engagement Strategy
Engagement Strategy
|
|
アクティブコンパレータ：Aim 2: Arm 7
Strategies 2 & 4
|
Engagement Strategy
Engagement Strategy
|
|
アクティブコンパレータ：Aim 2: Arm 8
Strategies 1, 2 & 4
|
Engagement Strategy
Engagement Strategy
Engagement Strategy
|
|
アクティブコンパレータ：Aim 2: Arm 9
Strategies 2-3
|
Engagement Strategy
Engagement Strategy
|
|
アクティブコンパレータ：Aim 2: Arm 10
Strategies 1, 3 & 4
|
Engagement Strategy
Engagement Strategy
Engagement Strategy
|
|
アクティブコンパレータ：Aim 2: Arm 11
Strategy 1
|
Engagement Strategy
|
|
アクティブコンパレータ：Aim 2: Arm 12
Strategy 2
|
Engagement Strategy
|
|
アクティブコンパレータ：Aim 2: Arm 13
Strategy 3
|
Engagement Strategy
|
|
アクティブコンパレータ：Aim 2: Arm 14
Strategy 4
|
Engagement Strategy
|
|
アクティブコンパレータ：Aim 2: Arm 15
Strategy 1 & 4
|
Engagement Strategy
Engagement Strategy
|
|
プラセボコンパレーター：Aim 2: Arm 16
No Strategies
|
No engagement 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 |
|---|---|---|
|
Attendance
時間枠：2 months after baseline
|
Attend at least 1 eINSPIRE session
|
2 months after baseline
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Feasibility of Engagement Strategies
時間枠：6 months from enrollment
|
Assessed via the Intervention Usability Scale, score of 70+ indicates feasibility
|
6 months from enrollment
|
|
Acceptability of Engagement Strategies
時間枠：6 months from enrollment
|
Assessed via the Acceptability of Intervention Measure; 70%+ agree/strongly agree indicates acceptability
|
6 months from enrollment
|
|
Appropriateness of Engagement Strategies
時間枠：6 months from enrollment
|
Assessed via the Intervention Appropriateness Measure; 70%+ agree/strongly agree indicates appropriateness
|
6 months from enrollment
|
協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Karen Osilla, PhD、Stanford University
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- IRB-86357
- 1R61DA064789-01 (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?
IPD プランの説明
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
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
米国FDA規制機器製品の研究
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Engagement Strategy 1の臨床試験
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University of WashingtonNational Institute of Mental Health (NIMH); Kenyatta National Hospital; University of Nairobi,...募集実装科学 | 思春期の HIV 感染症 | 実装戦略 | 成人向けケアへの移行ケニア
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