The T1D Parent Check-In: A Preventative Intervention

Type 1 Diabetes Clinical Trial

Official title:

The T1D Parent Check-In: A Preventative Intervention

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06160934
• Other study ID #: 2023P002600
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: June 2025

Study information

• Verified date: December 2023
• Source: Massachusetts General Hospital
• Contact: Ellen H O'Donnell, PhD
• Phone: 617-643-6017
• Email: ehodonnell[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Behavioral:
• T1D Parent Check-in
The Type 1 Diabetes (T1D) Parent Check-in is an innovative, 3-session, T1D-specific intervention for parents of newly diagnosed children and adolescents that can be delivered via telehealth. The T1D Parent Check-in is an adaptation of The Parent Check-In, a brief, prevention-based parenting intervention developed by Grolnick, Levitt, Caruso, & Lerner (2021). The T1D Parent Check-in is designed to promote parenting skills on dimensions of autonomy support, structure and involvement that facilitate children's adjustment and motivation, and integrates skills from cognitive-behavioral therapy, customized to be highly relevant to families with a child 6-12 months from new diagnosis of T1D. The intervention is intended to promote diabetes-related resilience and positive psychological and medical outcomes among families of children with T1D.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Boston Children's Hospital, Juvenile Diabetes Research Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Rate	Recruitment data measured by percent of eligible families that were approached for participation that enrolled in study.	Through study completion, an average of 8 months
Primary	Intervention Completion Rate	Feasibility of the intervention measured by percentage of intervention group participants who complete all three sessions of the intervention.	Through study completion, an average of 8 months
Primary	Client Satisfaction Questionnaire	Participants in the intervention arm will complete the standardized Client Satisfaction Questionnaire (CSQ), a measure of overall satisfaction with the intervention.	Through study completion, an average of 8 months
Secondary	Parenting in Pediatric Diabetes Questionnaire	Parents will rate their parenting in relation to their children's diabetes management.	Through study completion, an average of 8 months
Secondary	Health Mindset Scale	Parents will complete the Health Mindset Scale, rating their beliefs about health as more changeable versus fixed.	Through study completion, an average of 8 months
Secondary	Diabetes Problem Solving Interview (DPSI)	Parents will complete the standardized DPSI interview to evaluate diabetes-specific problem-solving.	Through study completion, an average of 8 months
Secondary	Parent Problem Areas in Diabetes for Children and Teens	Parents will complete the standardized Parent Problem Areas in Diabetes for Children and Teens to evaluate diabetes-related distress.	Through study completion, an average of 8 months
Secondary	Diabetes Family Conflict Scale	Parents will complete the Diabetes Family Conflict Scale - Parent Report (DFCS) and rate how often they argued with their children over the past month across various tasks of diabetes management (e.g., remembering to check blood sugars).	Through study completion, an average of 8 months
Secondary	Connor-Davidson's Resilience Scale (CD-RISC-10)	Parents will complete the Connor-Davidson's Resilience Scale (CD-RISC-10), a widely used measure of psychological resilience.	Through study completion, an average of 8 months
Secondary	Parenting Efficacy	The Parenting Efficacy scale measures parents' perceptions of efficacy in their parenting role.	Through study completion, an average of 8 months
Secondary	Type 1 Diabetes and Life (T1DAL)	Parents will reflect on their own quality of life as a parent of a child or teen with T1D by completing the standardized Type 1 Diabetes and Life (T1DAL) measure.	Through study completion, an average of 8 months
Secondary	Child Hemoglobin A1C	The child's most proximate HbA1C value will be collected from their electronic medical record.	Through study completion, an average of 8 months
Secondary	Time in Range	Children's prior one month time in range (TIR) will be collected for patients on continuous glucose monitors (CGM).	Through study completion, an average of 8 months