Empowered Relief for Caregivers (ER-CY)
Empowered Relief for Caregivers (ER-CY): A Co-Designed Brief Intervention to Support Families of Youth With Chronic Pain
This study is testing a new program called Empowered Relief for Caregivers (ER-CY), designed to support caregivers of children and teens who live with chronic pain. ER-CY is a single two-hour class delivered online. It teaches skills for managing the stress of caring for a child in pain and for responding to a child's pain in helpful ways.
Up to 80 caregivers of youth with chronic pain will take part in one ER-CY class and then complete surveys and a short interview over the following three months. The researchers want to learn two things: whether caregivers are willing and able to take part and find the program helpful and satisfying, and whether the program lowers caregiver distress and improves their child's day-to-day functioning. What is learned will help guide future programs and care for youth with chronic pain and their families.
調査の概要
状態
詳細な説明
Background and Rationale: Chronic pain is common in youth and is associated with significant long-term physical and mental health consequences, yet it remains under-recognized and undertreated. Cognitive behavioral therapy (CBT) is an effective treatment, but access barriers limit its reach, leaving a gap for scalable, accessible interventions. Empowered Relief (ER) is a single-session, skills-based intervention that has produced outcomes comparable to multi-session CBT in adults; a youth adaptation (ER-Y) has shown strong feasibility, acceptability, and effectiveness. At the same time, caregiver distress, including anxiety and depressive symptoms, is associated with worse child pain outcomes, but few brief, accessible interventions exist to support caregivers themselves. To address this gap, the investigators co-designed Empowered Relief for Caregivers (ER-CY), a brief virtual intervention for caregivers of youth with chronic pain, and designed this study to evaluate its feasibility, acceptability, and preliminary effectiveness.
Objectives: The study has two aims. Aim 1 is to assess the feasibility and acceptability of ER-CY, indexed by participant attendance and ratings of credibility and satisfaction. Aim 2 is to evaluate preliminary effectiveness, indexed by caregiver distress, caregiver behavior in response to their child's pain, and parent-reported youth pain interference. The investigators hypothesize that ER-CY will demonstrate strong feasibility and acceptability and that caregivers will show reduced distress and reduced unhelpful responses to pain, along with improvements in youth pain-related functioning over time.
Design and Procedures: This is a single-group study enrolling up to 80 caregivers of youth with chronic pain, conducted at the Pediatric Pain Management Clinic at Stanford Medicine Children's Health. Caregivers identified through the clinic complete an eligibility questionnaire, a screening call, and informed consent, and then complete baseline surveys via REDCap. Participants attend one approximately two-hour ER-CY class delivered virtually via Zoom and complete post-class surveys immediately afterward. Within one to two weeks, participants complete a semi-structured qualitative interview, which is audio- and video-recorded for analysis. Outcome and monitoring assessments are repeated at 1, 2, and 3 months following the intervention. Changes over time will be examined using mixed-effects models, and no interim analysis is planned.
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：Jeremy Giberson
- 電話番号：650-723-5814
- メール：jgiberso@stanford.edu
研究連絡先のバックアップ
- 名前：Sahrish Masood
- メール：sahrishm@stanford.edu
研究場所
-
-
California
-
Palo Alto、California、アメリカ、94304
- Stanford University
-
主任研究者：
- Laura Simons, PhD
-
コンタクト：
- Jeremy Giberson
- 電話番号：650-723-5814
- メール：jgiberso@stanford.edu
-
コンタクト：
- Sahrish Masood
- メール：sahrishm@stanford.edu
-
-
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
Inclusion Criteria:
- Caregiver of a youth with a chronic pain diagnosis (>3 months in duration)
- English speaking
Exclusion Criteria:
- Significant psychosocial complexity based on clinical team assessment (e.g., severe depression/anxiety, unable to tolerate a group setting)
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：なし
- 介入モデル：単一グループの割り当て
- 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 |
|---|---|
|
実験的：Empowered Relief for Caregivers (ER-CY)
Participants in this single-group study attend one approximately two-hour Empowered Relief for Caregivers class, a co-designed, skills-based intervention delivered virtually via Zoom.
The class teaches caregivers of youth with chronic pain strategies to manage their own distress and to respond adaptively to their child's pain.
All enrolled participants receive the ER-CY intervention; there is no comparison arm.
|
Empowered Relief for Caregivers is a single-session, skills-based behavioral intervention delivered virtually via Zoom in one session of approximately two hours.
Co-designed with caregivers, it adapts the Empowered Relief approach for caregivers of youth with chronic pain, teaching strategies to reduce caregiver distress and to respond more adaptively to a child's pain.
All participants receive the same single class; there are no additional sessions or booster components.
|
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 |
|---|---|---|
|
プログラムフィードバックスケール
時間枠：授業後すぐに
|
プログラム フィードバック スケールは、受け入れ可能性と実現可能性の認識を示す 7 つのステートメントに対する参加者の同意をスケール (スコア 0 = 「まったく同意しない」から 4 = 「本当に同意する」) に基づいて評価します。スコアが高いほど、肯定的なフィードバックと 2 つの自由形式の質問を示します。
|
授業後すぐに
|
|
Treatment Expectancy and Credibility: Caregiver Version
時間枠：Immediately post class
|
The Treatment Expectancy and Credibility: Caregiver Version assesses treatment expectations and credibility with standardized sum scores from using a numeric rating scale (score 0 = "not at all" to 10 = "very much") with a higher score indicating high expectations.
|
Immediately post class
|
|
Exit Interview
時間枠：1-2 weeks post class
|
Semi-structured qualitative interview conducted with caregivers following the ER-CY class to assess intervention acceptability and gather feedback on their experience.
Interviews are audio/video recorded, transcribed, and analyzed thematically to characterize caregivers' perspectives on program content, delivery, perceived helpfulness, and suggestions for refinement.
|
1-2 weeks post class
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Adult Responses to Children's Symptoms (ARCS) - Protect Subscale
時間枠：Pre-class, 1 month, 2 months, and 3 months post class
|
Pre-class, 1 month, 2 months, and 3 months post class
|
|
Bath Adolescent Pain Parental Impact Questionnaire
時間枠：Pre-class, 1 month, 2 months, and 3 months post class
|
Pre-class, 1 month, 2 months, and 3 months post class
|
|
Child Activity Limitations Interview-9
時間枠：Pre-class, 1 month, 2 months, and 3 months post class
|
Pre-class, 1 month, 2 months, and 3 months post class
|
|
Generalized Anxiety Disorder-2
時間枠：Pre-class, 1 month, 2 months, and 3 months post class
|
Pre-class, 1 month, 2 months, and 3 months post class
|
|
Pain Catastrophizing Scale - Parent
時間枠：Pre-class, 1 month, 2 months, and 3 months post class
|
Pre-class, 1 month, 2 months, and 3 months post class
|
|
Pain Catastrophizing Scale
時間枠：Pre-class, 1 month, 2 months, and 3 months post class
|
Pre-class, 1 month, 2 months, and 3 months post class
|
|
Patient Health Questionnaire-2
時間枠：Pre-class, 1 month, 2 months, and 3 months post class
|
Pre-class, 1 month, 2 months, and 3 months post class
|
|
Parent Psychological Flexibility Questionnaire - 10
時間枠：Pre-class, 1 month, 2 months, and 3 months post class
|
Pre-class, 1 month, 2 months, and 3 months post class
|
|
Parent Risk and Impact Screening Measure - 12
時間枠：Pre-class, 1 month, 2 months, and 3 months post class
|
Pre-class, 1 month, 2 months, and 3 months post class
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Laura Simons, 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
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。