Type 1 DiabetesNCT06160934
The T1D Parent Check-In: A Preventative Intervention
A study testing T1D Parent Check-in in people with Type 1 Diabetes and Diabetes in Children, run by Massachusetts General Hospital at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes, Diabetes in Children
- What is being tested?
- T1D Parent Check-in
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
Read the 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
- Being tested
- T1D Parent Check-in
- Keywords
- Pediatrics, Pediatric Endocrinology, Parenting Intervention, Pediatric Type 1 Diabetes, Pediatric Psychology
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T1D Parent Check-inBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Recruitment data measured by percent of eligible families that were approached for participation that enrolled in study.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 8 months
Secondary outcomes (10)
Parenting in Pediatric Diabetes Questionnaire
Parents will rate their parenting in relation to their children's diabetes management.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Through study completion, an average of 8 months
Parenting Efficacy
The Parenting Efficacy scale measures parents' perceptions of efficacy in their parenting role.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Through study completion, an average of 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start1 Feb 2024
- Primary completion30 Jun 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, Boston Children's Hospital
- Responsible party
- Principal investigator, Ellen H. O'Donnell, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160934
- Sponsor's protocol ID
- 2023P002600
- Status last verified
- Oct 2026
- First submitted
- 20 Nov 2023
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The T1D Parent Check-In: A Preventative Intervention
- ClinicalTrials.gov ID
- NCT06160934
- Acronym / sponsor ID
- 2023P002600
- Conditions
- Type 1 Diabetes, Diabetes in Children
- Keywords
- Pediatrics, Pediatric Endocrinology, Parenting Intervention, Pediatric Type 1 Diabetes, Pediatric Psychology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, Boston Children's Hospital
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 7 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: T1D Parent Check-inThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T1D Parent Check-inThe 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. | Behavioural | Intervention Group |
Primary outcome
Recruitment Rate
Time frame: Through study completion, an average of 8 months
Recruitment data measured by percent of eligible families that were approached for participation that enrolled in study.
Intervention Completion Rate
Time frame: Through study completion, an average of 8 months
Feasibility of the intervention measured by percentage of intervention group participants who complete all three sessions of the intervention.
Client Satisfaction Questionnaire
Time frame: Through study completion, an average of 8 months
Participants in the intervention arm will complete the standardized Client Satisfaction Questionnaire (CSQ), a measure of overall satisfaction with the intervention.
10 secondary outcomes
Parenting in Pediatric Diabetes Questionnaire
Time frame: Through study completion, an average of 8 months
Health Mindset Scale
Time frame: Through study completion, an average of 8 months
Diabetes Problem Solving Interview (DPSI)
Time frame: Through study completion, an average of 8 months
Parent Problem Areas in Diabetes for Children and Teens
Time frame: Through study completion, an average of 8 months
Diabetes Family Conflict Scale
Time frame: Through study completion, an average of 8 months
Connor-Davidson's Resilience Scale (CD-RISC-10)
Time frame: Through study completion, an average of 8 months
Parenting Efficacy
Time frame: Through study completion, an average of 8 months
Type 1 Diabetes and Life (T1DAL)
Time frame: Through study completion, an average of 8 months
Child Hemoglobin A1C
Time frame: Through study completion, an average of 8 months
Time in Range
Time frame: Through study completion, an average of 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T1D Parent Check-in in people with Type 1 Diabetes and Diabetes in Children, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: Through study completion, an average of 8 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.