The T1D Parent Check-In: A Preventative Intervention

NCT ID: NCT06160934

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2026-06-30

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.

Conditions

Type 1 Diabetes; Diabetes in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

T1D Parent Check-in

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Juvenile Diabetes Research Foundation

OTHER

Sponsor Role: collaborator

Boston Children's Hospital

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ellen H. O'Donnell

Assistant Professor Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2023P002600

Identifier Type: -

Identifier Source: org_study_id