Development of a Parent Training Intervention for Pediatric Patients With Pain
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 39
- 试验地点
- 4
- 主要终点
- Feasibility - Acceptance
研究概览
简要总结
The primary objective is to assess the feasibility and acceptability of a group-based parent training intervention for parents of youth with chronic pain. Secondary objectives include evaluating changes in child functional impairment, pain intensity, and parent accommodation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 10-17 with chronic pain (≥3 months) and associated functional impairment
- •Parent/guardian living with the child ≥50% of the time
- •Parent and child are fluent in English
排除标准
- •Pain better explained by another medical condition
- •History of psychosis, bipolar disorder, autism spectrum disorder, or intellectual disability (child)
- •Current emotional, cognitive, or physical barrier to participation for caregiver, as determined by clinical judgment of study personnel
- •Severe psychiatric symptoms requiring immediate intervention
- •Ongoing individual Cognitive Behavioral Therapy (CBT) for pain
研究组 & 干预措施
Parents of youth with chronic pain
Parents of youth with chronic pain will complete questionnaires assessing secondary outcome measures prior to the start of the parent-only group intervention.
The parent-only group intervention is 6 weekly, 90 minute sessions held over a secure virtual platform. Sessions will focus on orientation to the group, psychoeducation about pain neuroscience, and the role of parents in pain management, how parents can increase support for their child as well as decrease behaviors that may inadvertently maintain or reinforce pain and pain-related behaviors. Sessions will be recorded to ensure consistency in session content across groups. Homework will be assigned to parents after each session and will be reviewed the following week.
Parents of youth with chronic pain will be asked to complete questionnaires at the end of the intervention (45 minutes), and repeat some of the questionnaires at follow up time points (35-40 minutes).
干预措施: Supportive Parenting for Anxious Childhood Emotions - Pain (Behavioral)
Youth with chronic pain
Youth with chronic pain will complete questionnaires assessing secondary outcome measures prior to the start of the parent-only group intervention.
The parent-only group intervention is 6 weekly, 90 minute sessions held over a secure virtual platform. Sessions will focus on orientation to the group, psychoeducation about pain neuroscience, and the role of parents in pain management, how parents can increase support for their child as well as decrease behaviors that may inadvertently maintain or reinforce pain and pain-related behaviors. Sessions will be recorded to ensure consistency in session content across groups. Homework will be assigned to parents after each session and will be reviewed the following week.
Youth with chronic pain will then be asked to complete questionnaires at the end of the intervention, and at 1-month and 3-month follow up time points. Questionnaire completion is expected to take about 20 minutes at each time point.
结局指标
主要结局
Feasibility - Acceptance
时间窗: From enrollment through the end of the treatment (6-8 weeks)
Feasibility of intervention as measured by the mean of number of sessions attended. Local session documents will track each session.
Acceptability - Client Satisfaction
时间窗: Post-treatment (6-8 weeks)
Client satisfaction with the intervention will be measured by the patient-reported Client Satisfaction Questionnaire. The Client Satisfaction Questionnaire is an 8-item, widely used, self-report measure for assessing general client satisfaction with mental health services. It uses a 4-point Likert scale for each question. This will be administered to parents, who received the intervention. Total scores range from 8 to 32, with higher scores indicating greater satisfaction. Parents of youth with chronic pain will be asked to complete this measure at the end of the intervention.
Acceptability - Provider
时间窗: Post-treatment (6-8 weeks)
Provider will assess the acceptability of the measure by the Acceptability of Intervention Measure. This 4-item measure is measured on a 5-point Likert scale (1 = completely disagree; 5 = completely agree). Scoring involves calculating the mean of the 4 items (range 1-5), with higher scores indicating higher acceptability. Providers will be asked to complete this measure at the end of the intervention.
Provider Intervention Appropriateness
时间窗: Post-treatment (6-8 weeks)
Provider will assess the appropriateness of the measure by the Intervention Appropriateness Measure. This 4-item measure is measured on a 5-point Likert scale (1 = completely disagree; 5 = completely agree). Scoring involves calculating the mean of the 4 items (range 1-5), with higher scores indicating higher degree of appropriateness. Providers will be asked to complete this measure at the end of the intervention
Feasibility - Provider
时间窗: Post-treatment (6-8 weeks)
Provider will assess the feasibility of the measure by the Feasibility of Intervention Measure. This 4-item measure is measured on a 5-point Likert scale (1 = completely disagree; 5 = completely agree). Scoring involves calculating the mean of the 4 items (range 1-5), with higher scores indicating higher degree of feasibility. Providers will be asked to complete this measure at the end of the intervention
次要结局
- Anxiety - Child(Baseline)
- Anxiety - Child(Post-Treatment (6-8 weeks))
- Anxiety - Child(1 month Post-Treatment)
- Anxiety - Child(3 months Post-Treatment)
- Anxiety - Parent(Baseline)
- Anxiety - Parent(Post-Treatment (6-8 weeks))
- Anxiety - Parent(1 month Post-Treatment)
- Anxiety - Parent(3 months Post-Treatment)
- Depression - Child(Baseline)
- Depression - Child(Post-Treatment (6-8 weeks))
- Depression - Child(1 month Post-Treatment)
- Depression - Child(3 months Post-Treatment)
- Depression - Parent(Baseline)
- Depression - Parent(Post-Treatment (6-8 weeks))
- Depression - Parent(1 month Post-Treatment)
- Depression - Parent(3 months Post-Treatment)
- Parent Stress(Baseline)
- Parent Stress(Post-Treatment (6-8 weeks))
- Parent Stress(1 month Post-Treatment)
- Parent Stress(3 months Post-Treatment)
- Parent Accommodation(Baseline)
- Parent Accommodation(Post-Treatment (6-8 weeks))
- Parent Accommodation(1 month Post-Treatment)
- Parent Accommodation(3 months Post-Treatment)