Promoting Resilience in Youth With Type 1 Diabetes: Pilot of Strengths-Based Family Intervention to Improve Diabetes Outcomes (Diabetes Strengths Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 2
- 主要终点
- Feasibility of Study Design
研究概览
简要总结
The purpose of this study is to determine whether a newly developed intervention is feasible and acceptable to adolescents with type 1 diabetes and their families and diabetes care providers, and to evaluate trends in whether the intervention impacts important diabetes outcomes. The intervention involves diabetes care providers discussing and reinforcing individuals' and families' diabetes management strengths during routine, outpatient diabetes care appointments.
详细描述
The purpose of this study is to pilot test a newly developed strengths-based clinical intervention delivered by diabetes care providers in the context of routine ambulatory diabetes care, designed to promote resilience and support diabetes management among adolescents with type 1 diabetes and their families. The emphasis of the intervention is shifting the tone of clinical encounters for diabetes care to emphasize and reinforce youths' and families' current diabetes strengths and positive diabetes management behaviors. Youth with type 1 diabetes are seen routinely in clinic every 3-4 months, and this intervention will occur at two consecutive clinic visits. The intervention consists of (A) assessing youth and family diabetes strengths and adherence prior to each visit, and (B) training diabetes care providers to tailor their clinical encounters around reinforcing each patient and family's unique "diabetes strengths profile" generated from the strengths and adherence assessments.
Outcome assessments are conducted at baseline (prior to the start of the intervention) and immediately following the conclusion of the intervention (approximately 6-8 months later). The primary outcome is feasibility and acceptability, measured by qualitative feedback from participants and providers, as well as quantification of recruitment and enrollment, provider adherence to intervention protocol, and time to completion. Secondary (exploratory) outcomes include diabetes regimen adherence, glycemic control, family conflict, diabetes burden, diabetes strengths, and satisfaction with the diabetes care provider relationship. Strengths and adherence assessments are also completed prior to the second clinic visit to generate the diabetes strengths profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least one parent of each adolescent, self-identified as the primary caregiver most involved in diabetes care, will also be enrolled with each adolescent participant. When present, secondary caregivers involved in diabetes management will be invited (not required) to participate.
- •Youth type 1 diabetes diagnosis for at least 12 months, to allow ample opportunity for adjustment to diabetes management
- •Youth and parent fluency in written and spoken English because assessment measures are not available in other languages.
排除标准
- •(1) Presence of a serious mental illness or developmental disability in youth or parent that would impede participation would exclude eligibility.
结局指标
主要结局
Feasibility of Study Design
时间窗: 6-8 months after intervention begins (immediately following second study visit)
Measured by percent of participants who provided complete data from all questionnaires.
Acceptability: Number of Participants That Felt the Intervention Was Well-Received
时间窗: 6-8 months after enrollment (follow-up timepoint)
The number of participants that felt the intervention was well-received was collected for Adolescents, Parents, and Providers. To determine if the intervention was well-received, verbal responses from qualitative interviews with were coded for types of participant feedback by the study team. We coded these data qualitatively and classified them as Positive, Negative, or Neutral.
次要结局
- Diabetes Strengths(3-4 months after enrollment (mid-intervention timepoint), and 6-8 months after enrollment (follow-up timepoint))
- Diabetes Self-Management Profile - Parent-report(3-4 months after enrollment (mid-intervention timepoint), and 6-8 months after enrollment (follow-up timepoint))
- Diabetes Self-Management Profile - Adolescent-report(6-8 months after enrollment (follow-up timepoint))
- Diabetes Regimen Adherence (Blood Glucose Monitoring Frequency)(6-8 months after enrollment (follow-up timepoint))
- Problem Areas in Diabetes - Teen(6-8 months after enrollment (follow-up timepoint))
- Diabetes Burden - Problem Areas in Diabetes - Parent-report(6-8 months after enrollment (follow-up timepoint))
- Diabetes-related Family Conflict (Adolescent Report)(6-8 months after enrollment (follow-up timepoint))
- Adolescent-provider Relationship - Adolescent-report(6-8 months after enrollment (follow-up timepoint))
- Glycemic Control(6-8 months after enrollment (follow-up timepoint))
- Diabetes-related Family Conflict (Parent-report)(6-8 months after enrollment (follow-up timepoint))
- Healthcare Satisfaction - PedsQL Healthcare Satisfaction Parent-report(6-8 months after enrollment (follow-up timepoint))
- Provider-family Relationship, Provider-report(6-8 months after enrollment (follow-up timepoint))
研究者
Marisa Hilliard
Assistant Professor of Pediatrics
Baylor College of Medicine