An interventional study of T1D Parent Check-in in Type 1 Diabetes and Diabetes in Children, sponsored by Massachusetts General Hospital. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Prevention
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.
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.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 576 are open to participants now.
This study's enrollment of 50 is above the median of 40 across 2,648 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: T1D Parent Check-in
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.
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.
Recruitment Rate
Recruitment data measured by percent of eligible families that were approached for participation that enrolled in study.
Time frame: Through study completion, an average of 8 months
Intervention Completion Rate
Feasibility of the intervention measured by percentage of intervention group participants who complete all three sessions of the intervention.
Time frame: Through study completion, an average of 8 months
Client Satisfaction Questionnaire
Participants in the intervention arm will complete the standardized Client Satisfaction Questionnaire (CSQ), a measure of overall satisfaction with the intervention.
Time frame: Through study completion, an average of 8 months
Parenting in Pediatric Diabetes Questionnaire
Parents will rate their parenting in relation to their children's diabetes management.
Time frame: Through study completion, an average of 8 months
Health Mindset Scale
Parents will complete the Health Mindset Scale, rating their beliefs about health as more changeable versus fixed.
Time frame: Through study completion, an average of 8 months
Diabetes Problem Solving Interview (DPSI)
Parents will complete the standardized DPSI interview to evaluate diabetes-specific problem-solving.
Time frame: Through study completion, an average of 8 months
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.
Time frame: Through study completion, an average of 8 months
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).
Time frame: Through study completion, an average of 8 months
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.
Time frame: Through study completion, an average of 8 months
Parenting Efficacy
The Parenting Efficacy scale measures parents' perceptions of efficacy in their parenting role.
Time frame: Through study completion, an average of 8 months
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.
Time frame: Through study completion, an average of 8 months
Child Hemoglobin A1C
The child's most proximate HbA1C value will be collected from their electronic medical record.
Time frame: Through study completion, an average of 8 months
Time in Range
Children's prior one month time in range (TIR) will be collected for patients on continuous glucose monitors (CGM).
Time frame: Through study completion, an average of 8 months
Plan to share: No
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This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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