The T1D Parent Check-In: A Preventative Intervention
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Recruitment Rate
研究概览
简要总结
The goal of this clinical trial is to learn how to best support families during the first year of a child or teen's Type 1 diabetes (T1D) diagnosis. Specifically, we are testing a parenting intervention, the T1D Parent Check-in, designed for parents of children, ages 8 to 17 years, who have been newly diagnosed with T1D. This three-session intervention is delivered by diabetes psychologists over telehealth with the goal of helping families adjust to T1D, build resilience, and improve children's long-term health.
For this trial, our main question is whether parents like the intervention and find it to be helpful and worth their time and effort. We also want to test whether participating in the intervention helps parents feel more confident in their parenting and problem-solving around diabetes, feel less worried about diabetes, reduce family conflict, and improve children's quality of life. To answer these questions, we will randomly assign study participants to one of two groups; parents will either 1) receive the T1D Parent Check-in intervention, or 2) receive their usual care through clinic. Parents assigned to the second group will have the option of participating in a one-time meeting with the psychologist at the end of the study to receive general information/resources from the study and receive feedback on their questionnaires. Parents in both groups will be asked to complete questionnaires four times over the course of six months. Parents will be paid to complete the questionnaires.
详细描述
The purpose of the project is to develop and pilot an innovative, 3-session, Type 1 Diabetes-specific telehealth intervention for parents of newly diagnosed children and adolescents. This study is a multi-method, mixed quantitative and qualitative pilot project that will inform a future randomized control trial (RCT). The intervention will be piloted at two pediatric diabetes clinics: Massachusetts General Hospital (MGH) for Children and Boston Children's Hospital (BCH). Families of patients ages 8-17 years diagnosed with T1D within the past 3-9 months will be invited to participate in the study and then be randomly assigned to either the intervention group or a treatment-as-usual (TAU) group, with a goal of 25 families per group.
Measures of key outcomes (i.e., feasibility and acceptability measures, measures of diabetes-related resilience, distress, and family conflict, problem-solving, parenting style, parental stress, parent/child adjustment to children's chronic illness diagnosis, and health mindsets) will be collected via parent survey at baseline (T1), post-intervention (T2), 1-month follow-up (T3) and 6-month follow-up (T4) for within and between groups analyses. Qualitative feedback on the intervention will be sought from participating families after the third session (T2) and feedback on families' needs in the first year of diagnosis will be sought from all participants at T4. Additional information will be gathered from the medical record on diabetes regimen, HbA1c and demographics for descriptive statistics. This will also allow for exploratory analysis of change in HbA1c pre- to post-intervention and differences in glycemic control between groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parents/ primary caregivers (aged >18) of pediatric patients (ages 8-17 years), who have been diagnosed with T1D for at least 3 months, but not greater than 9 months (to ensure the intervention can be delivered within the first year of diagnosis)
- •At least one caregiver (>18) proficient in the English language, as neither the intervention nor scales used in the study have been validated in other languages. The age range of the patient with diabetes 8-17 was chosen to include both middle childhood and adolescence when diagnosis of Type 1 diabetes is most common.
排除标准
- •Parents' developmental delay or other cognitive impairment that may interfere with their completion of questionnaires or understanding of psychoeducational concepts, and
- •Parental scores in the "severe" range of depression and anxiety, evaluated using routine screening measures for depression and anxiety and which may indicate the parent requires a higher level of care.
研究组 & 干预措施
Intervention Group
The T1D Parent Check-in Group (Intervention Group) will participate in three sessions that will be delivered by a licensed clinical psychologist. In the larger RCT, the intervention will be manualized with training and a treatment protocol that can be delivered by any trained member of the diabetes psychosocial team (e.g., social workers, licensed mental health clinicians, and/or clinical psychologists). The intervention is designed to be both tailored and flexible but with fidelity to a basic structure. Diabetes-specific handouts and videos will be created as part of the intervention and will be provided to families throughout the course of the study.
干预措施: T1D Parent Check-in (Behavioral)
Treatment as Usual (TAU) Group
Parents assigned to the Treatment As Usual (TAU) group will complete T1-T4 study questionnaires alongside the intervention group. They will also take the Motivation Quiz as part of their T2 questionnaires. Instead of a one-month phone call, these participants will be scheduled for a one-time consultation with a study psychologist after completing their T4 questionnaires. This consultation will entail reviewing the family's specific questionnaire results, discussing challenges/strategies relevant to the family's needs, and providing additional recommendations/referrals as indicated. Families will also be provided access to study resources that will assist with their family's overall adjustment to T1D.
结局指标
主要结局
Recruitment Rate
时间窗: Through study completion, an average of 8 months
Recruitment data measured by percent of eligible families that were approached for participation that enrolled in study.
Intervention Completion Rate
时间窗: Through study completion, an average of 8 months
Feasibility of the intervention measured by percentage of intervention group participants who complete all three sessions of the intervention.
Client Satisfaction Questionnaire
时间窗: Through study completion, an average of 8 months
Participants in the intervention arm will complete the standardized Client Satisfaction Questionnaire (CSQ), a measure of overall satisfaction with the intervention.
次要结局
- Parenting in Pediatric Diabetes Questionnaire(Through study completion, an average of 8 months)
- Connor-Davidson's Resilience Scale (CD-RISC-10)(Through study completion, an average of 8 months)
- Parent Problem Areas in Diabetes for Children and Teens(Through study completion, an average of 8 months)
- Diabetes Family Conflict Scale(Through study completion, an average of 8 months)
- Parenting Efficacy(Through study completion, an average of 8 months)
- Time in Range(Through study completion, an average of 8 months)
- Health Mindset Scale(Through study completion, an average of 8 months)
- Child Hemoglobin A1C(Through study completion, an average of 8 months)
- Diabetes Problem Solving Interview (DPSI)(Through study completion, an average of 8 months)
- Type 1 Diabetes and Life (T1DAL)(Through study completion, an average of 8 months)
研究者
Ellen H. O'Donnell
Assistant Professor Principal Investigator
Massachusetts General Hospital