The T1D Parent Check-In: A Preventative Intervention

NCT06160934 | Active Not Recruiting

• 1 other identifier: 2023P002600
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes; Diabetes in Children

Keywords

Pediatrics; Pediatric Endocrinology; Parenting Intervention; Pediatric Type 1 Diabetes; Pediatric Psychology

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (10)

• Parenting in Pediatric Diabetes Questionnaire

  Through study completion, an average of 8 months

• Health Mindset Scale

  Through study completion, an average of 8 months

• Diabetes Problem Solving Interview (DPSI)

  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

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Treatment as Usual (TAU) Group

NO INTERVENTION

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.

Interventions

T1D Parent Check-in 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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Juvenile Diabetes Research Foundation: collaborator
• Boston Children's Hospital: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: December 7, 2023
• Study Start: February 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)