A Pilot Efficacy and Implementation Study of the Strengths Intervention Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 2
- 主要终点
- Change in Parent-Adolescent Communication (PACS)
研究概览
简要总结
The purpose of this study is to test a strengths-based intervention to be delivered in a primary care setting with adolescents and a parent. Investigators want to find out if the intervention can help parents and teens communicate. Specifically Investigators want to see if they can help parents and teens identify and build teen's strengths. Half the dyads will receive the educational materials in conjunction with their teen's well-child visit, while the other half will receive usual care at the well-child visit and receive the educational materials at the end of the study. Additionally, Investigators expect that a strengths-based intervention may also impact adherence to treatment in youth with a chronic illness. As such, Investigators will include a subgroup of teenagers diagnosed with asthma in this study, to assess whether the strengths-based intervention that the Investigators developed has an impact on adherence.
详细描述
Recent research suggests that parents and adolescents report an interest in doctors facilitating increased parent-teen communication about teen strengths. However, little research focuses on how to address this need in a primary care setting. Content from subject matter experts along with data gathered from parents and teens were used to develop a novel strengths-based intervention to be tested in primary care.
The study intervention being examined is called the Strengths Intervention Project and includes a written pamphlet, a guided discussion activity, in-person/phone health coaching, and in-person or mailed health care provider endorsement and key messaging. Measures will be collected at baseline pre-intervention (T1), in clinic or over the phone at the time of the intervention (T2), approximately two weeks post-intervention (T3), and approximately 2 months post-intervention (T4). Daily diaries will also be utilized twice to gather data pre- and post- intervention. We will measure feasibility of clinic implementation of intervention, as well as influence of intervention on parent-teen communication and adolescent outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Teens age 13 to 15 years at the time of their upcoming well-child visit (Arm 1) OR Teens age 13 to 15 years at the time of their last well-child visit (Arm 2)
- •Children's Hospital of Philadelphia (CHOP) primary care patient (Arm 1 and 2)
- •Scheduled for a well-child visit that parent and teen both plan to attend (Arm 1) OR Attended a well-child visit with parent (Arm 2)
- •Diagnosed with Asthma > year (asthma subgroup; Arm 1 only)
- •Prescribed a controller medication year-round (asthma subgroup; Arm 1 only)
- •Adolescent has their own email account to complete electronic surveys (Arm 1 and 2)
排除标准
- •Not fluent in written or spoken English (Arm 1 and 2)
- •Attending a new patient well-child visit (Arm 1) OR attended a new patient well-child visit (Arm 2)
- •Presence of developmental delay or pervasive developmental disorder that requires special education services (Arm 1 and 2)
- •Psychiatric hospitalization of the adolescent in the past year (Arm 1 and 2)
- •Participated in studies: CHOP IRB # 15-011732 and/or CHOP IRB # 17-013895 (Arm 1 and 2)
- •Adolescent has sibling enrolled in (IRB 18-014922) (Arm 1 and 2)
- •Parent Criteria:
- •Inclusion Criteria:
- •Parent or legal guardian of a teen age 13 to 15 years at their upcoming well-child visit at a CHOP primary care practice (Arm 1) OR Parent or legal guardian of a teen age 13 to 15 years at their recent well-child visit at a CHOP primary care practice (Arm 2)
- •Parent has their own email account to complete electronic surveys (Arm 1 and 2)
- •Exclusion Criteria:
- •Not fluent in written or spoken English (Arm 1 and 2)
- •Participated in studies: CHOP IRB # 15-011732 and/or CHOP IRB # 17-013895 (Arm 1 and 2)
研究组 & 干预措施
Intervention Group (Arm 1- Main)
Will receive the "Build Your Teen's Strengths" educational pamphlet, health coaching sessions, and provider endorsement.
干预措施: Build and Support Your Teen's Strengths (Behavioral)
Control Group (Arm 1- Main)
Will receive usual care at well-child visit.
Intervention Group (Arm 1-asthma subgroup)
Will receive the "Build Your Teen's Strengths" educational pamphlet, health coaching sessions, and provider endorsement.
干预措施: Build and Support Your Teen's Strengths (Behavioral)
Control Group (Arm 1-asthma subgroup)
Will receive usual care at well-child visit.
Control Group (Arm 2)
Convenience sample used for a post-hoc, exploratory analysis. Will receive usual care at well-child visit.
结局指标
主要结局
Change in Parent-Adolescent Communication (PACS)
时间窗: Baseline (T1) and 2-months (T4)
20 items (parent and teens); Likert scale (1= strongly disagree; 5= strongly agree)
Feasibility of consent rates
时间窗: 9 months
Feasibility will be demonstrated by consent rates ≥60%
Feasibility of intervention implementation
时间窗: 1 month
Completion of core intervention components ≥ 70%.
Provider acceptability of intervention
时间窗: 9 months
Provider acceptability ratings ≥80%. Investigators will also elicit open-ended feedback.
Change in Beliefs about Adolescents
时间窗: Baseline (T1) and 2-months (T4)
26 items (parents only); Likert scale (1= very unlikely; 7= very, very likely)
Parent and adolescent acceptability of intervention materials (additional)
时间窗: 2-months post intervention (T4)
2 items (parents and teens); Yes/No/Not sure and Likert scale (1=very likely; 5 very unlikely)
Parent and adolescent acceptability of intervention materials
时间窗: 2-weeks post intervention (T3)
Adolescent and parent acceptability ratings ≥80%. Investigators will also elicit open-ended feedback.
Change in Confidence in exploring and using adolescent's strengths
时间窗: Baseline (T1) and 2-months (T4)
15 items (parents and teens); Likert scale (1=strongly disagree; 5= strongly agree)
次要结局
- Change in Psychological well-being using the Flourishing Scale(Baseline (T1) and 2-months (T4))
- Change in Adherence to inhaled controller medication use(Baseline (T1) and 2-months (T4))