Clinical trial NCT06160934: The T1D Parent Check-In: A Preventative Intervention
Official title: The T1D Parent Check-In: A Preventative Intervention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Diabetes in Children
Keywords: Pediatrics
Pediatric Endocrinology
Parenting Intervention
Pediatric Type 1 Diabetes
Pediatric Psychology
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Juvenile Diabetes Research Foundation
name: Boston Children's Hospital
First posted: 2023-12-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized into one of two groups: the T1D Parent Check-in Intervention group or the Treatment as Usual Group (TAU). Participants in the intervention and TAU groups will be yoked by age group (e.g., parent of an 8-12-year-old child will be yoked to another parent of an 8-12-year-old child) to minimize variability in effects due to differences in parenting by child age. Matching participants by clinic location (e.g., child receiving care at MGH will be yoked to another child receiving care at MGH) will serve as a natural control for differences in practice between clinic locations.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Recruitment Rate
timeFrame: Through study completion, an average of 8 months
measure: Intervention Completion Rate
timeFrame: Through study completion, an average of 8 months
measure: Client Satisfaction Questionnaire
timeFrame: Through study completion, an average of 8 months
Secondary outcomes:
measure: Parenting in Pediatric Diabetes Questionnaire
timeFrame: Through study completion, an average of 8 months
measure: Health Mindset Scale
timeFrame: Through study completion, an average of 8 months
measure: Diabetes Problem Solving Interview (DPSI)
timeFrame: Through study completion, an average of 8 months
measure: Parent Problem Areas in Diabetes for Children and Teens
timeFrame: Through study completion, an average of 8 months
measure: Diabetes Family Conflict Scale
timeFrame: Through study completion, an average of 8 months
measure: Connor-Davidson's Resilience Scale (CD-RISC-10)
timeFrame: Through study completion, an average of 8 months
measure: Parenting Efficacy
timeFrame: Through study completion, an average of 8 months
measure: Type 1 Diabetes and Life (T1DAL)
timeFrame: Through study completion, an average of 8 months
measure: Child Hemoglobin A1C
timeFrame: Through study completion, an average of 8 months
measure: Time in Range
timeFrame: Through study completion, an average of 8 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: