Type 1 Diabetes (T1D)NCT07109128
The T1D Talks Pilot Study
A study testing The T1D Talks: A Virtual Group for Teens and Tweens with T1D in people with Type 1 Diabetes (T1D), run by Western Michigan University School of Medicine at 1 site in United States.
Trial summary
Despite recent technological advances in type 1 diabetes (T1D) treatment, adolescents are the only age group for which glycemic levels have not improved. Technology and education help adolescents execute the mechanics of managing blood glucose levels, but do not help adolescents manage the emotional distress that… Read more about this study
- Who is it for?
- Ages 12 to 14 years
- Conditions the study is for
- Type 1 Diabetes (T1D)
- What is being tested?
- The T1D Talks: A Virtual Group for Teens and Tweens with T1D
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2024to 14 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- T1D for at least 1 year
- the ability to read/write and converse in English
- reliable internet connection and a virtual meeting capable device (tablet or laptop)
Who cannot join
- a chronic medical condition that requires intensive daily management
- a significant mental health or cognitive disability that would prevent them from participating
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Nemours Children's Hospital, Florida
Orlando, Florida, 32827
About this study
Official title: The T1D Talks Pilot Study: An Online Teen / Tween Group About Life With T1D and Managing the Emotions That Come With it
Despite recent technological advances in type 1 diabetes (T1D) treatment, adolescents are the only age group for which glycemic levels have not improved. Technology and education help adolescents execute the mechanics of managing blood glucose levels, but do not help adolescents manage the emotional distress that arises when T1D management goals conflict with social/emotional goals (e.g., taking insulin for a meal in front of new friends vs. trying to "fit-in"). The emotional distress caused by such situations can be difficult to manage and can lead to unhealthy risk behaviors and disengagement in T1D self-management (e.g., deciding to skip a lunch-time bolus to avoid bolusing in front of new friends).
A novel approach in T1D research is to target emotions directly by promoting emotion regulation skills. In the general population, emotion regulation interventions have demonstrated success in preventing both unhealthy behaviors and mood disorders among younger adolescents, including younger adolescents with social-emotional risk-factors like low SES. The investigators' scientific premise is that an emotion regulation intervention for younger adolescents with T1D (age 12-14) could promote skills to help youth manage emotional burdens of living with T1D, reduce unhealthy and risky T1D self-management behaviors, and prevent unhealthy patterns of behaviors and distress/mood disorders that often appear in later adolescence.
Read more
Using the ORBIT Model, a systematic framework for developing behavioral interventions for people with chronic diseases, the investigators adapted an evidence-based, manualized emotion regulation intervention for young adolescents, so that it is relevant for youth with T1D. The current study is a natural extension of this previous work. For the current study, the investigators propose to complete a feasibility and acceptability trial of this novel emotion regulation intervention for youth with T1D.
The investigators aimed to pilot the novel emotion regulation intervention (11 virtual group sessions) with 3 sequential groups of 6-8 young adolescents (age 12-14) with T1D in each group and obtain feedback from facilitators and participants and their parents after each session, and after the intervention.
- Conditions
- Type 1 Diabetes (T1D)
- Being tested
- The T1D Talks: A Virtual Group for Teens and Tweens with T1D
- Keywords
- adolescents, emotion regulation, group, virtual
- Medical subject headings
- Diabetes Mellitus, Type 1, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The T1D Talks: A Virtual Group for Teens and Tweens with T1DBehavioural
The T1D Talks intervention is an 11 session, virtual (online), group intervention. The T1D Talks intervention teaches developmentally appropriate emotion regulation (ER) skills and facilitates practicing these skills via role-plays and in-session experiences that are meant to elicit strong emotions. The investigators adapted the content and situations of an established intervention to be relevant for youth with T1D (e.g., practicing ER skills while role playing situations like telling parents about high blood glucose numbers or telling a coach about needing to take a time out from a game because of a low blood glucose level). The intervention also provides basic diabetes education about risky situations (e.g., how physical activity can affect blood glucose).
| Study group | Role | What they receive |
|---|---|---|
| The T1D Talks Virtual Group Intervention for Teens and Tweens with T1D | Experimental | Experimental: The T1D Talks Group Intervention. This is the intervention, as this is a proof of concept pilot study, we will only have an intervention arm. Receives: Behavioral: The T1D Talks: A Virtual Group for Teens and Tweens with T1D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of participants who attended the intervention
Feasibility will be demonstrated by average individual participation in at least 70% of the sessions, and >70% of participants completing the intervention by participating in the last session.
Measured: Through study completion, up to 12 weeks
Percent of participants who rated each session as acceptable
The percentage of participants who rated each session as "acceptable" on a post-session survey rating scales that were developed for this study. 6 items on the session evaluation survey assess the following: relevance, trust in the information, ease of understanding, learning novel information, and interest in topics. Item responses include a 5-point Likert scale from "strongly disagree to strongly agree". The research team will average participant's responses across the items, thus total score could be a minimum of 1 and a maximum of 5, with a higher score indicating higher acceptability of the intervention. The intervention will be considered acceptable if ≥ 70% of participants rate each session as acceptable, as indicated by a total score >3.
Measured: Through study completion, up to 12 weeks
Percent of participants who rated the overall intervention as acceptable
The percentage of participants who rated the intervention, as a whole, as "acceptable" on a post-intervention survey rating scales that were developed for this study. 16 items on the intervention evaluation survey assess, one's perceptions of the intervention. Item responses include a 5-point Likert scale from "strongly disagree to strongly agree". The research team will reverse score items that negatively worded and average participant's responses across the items, thus total score could be a minimum of 1 and a maximum of 5, with a higher score indicating higher acceptability of the intervention. The intervention will be considered acceptable if ≥ 70% of participants rate the intervention as acceptable, as indicated by a total score >3.
Measured: Through study completion, up to 12 weeks
Secondary outcomes (9)
Difficulties in Emotion Regulation- Short Form Scale
The change in the DERS-SF will be measured from baseline to post-intervention (up to 11 weeks). Self-report measure of emotion regulation strategies of particularly negative emotions, rated on a 5 point scale, with higher score indicating greater engagement in strategies.
Measured: Baseline to post-intervention, up to 11 weeks
Emotion Regulation Behaviors Scale (ERBS-R)
The change in the ERBS-R will be measured from baseline to post-intervention (up to 11 weeks). The ERBS-R measures the use of the specific emotion regulation strategies taught in the ER intervention. Using a scale of 1 ("never") to 5 ("all of the time"), with higher scores indicate more frequent use of the strategies taught.
Measured: Baseline to post-intervention, up to 11 weeks
Implicit Theories of Emotion Scale- Child Version (ITES-C)
The change in the ITES-C will be measured from baseline to post-intervention (up to 11 weeks). The ITES-C Self subscale assessed adolescents' beliefs about the controllability of their emotions. Six items were rated on a 6-point scale from "strongly disagree" to "strongly agree" and were averaged to create a score. Higher scores indicate stronger beliefs in an incremental theory of emotion (that emotions are malleable) as opposed to an entity theory (that emotions are fixed).
Measured: Baseline to post-intervention, up to 11 weeks
Affect Dysregulation Scale (ADS)
The change in the ADS will be measured from baseline to post-intervention (up to 11 weeks). The ADS assesses the frequency of adolescents' difficulties with affect regulation, with a higher score indicating greater difficulty.
Measured: Baseline to post-intervention, up to 11 weeks
Early Adolescent Temperament Questionnaire (EATQ-R select subscales)
The change in the EATQ-R will be measured from baseline to post-intervention (up to 11 weeks), including the following subscales: 5 subscales (29 items): Activation Control , Attention, Frustration , Inhibitory Control, and Surgency. The ADS assesses the frequency of adolescents' difficulties with affect regulation, with a higher score indicating greater difficulty. The current questionnaire has been designed to specifically tap experiences common to adolescents, and is available in self- and parent-report formats. It assesses temperament and self-regulation via adaptation of scales used in studies of children and adults.
Measured: Baseline to post-intervention, up to 11 weeks
Problem Areas in Diabetes: Teen (PAID-T)
The change in the PAID-T will be measured from baseline to post-intervention (up to 11 weeks). The PAID-T is a 26-item self-report measure of diabetes-specific emotional distress in teens with diabetes, rated on a 6 point scale, with higher scores indicating greater distress.
Measured: Baseline to post-intervention, up to 11 weeks
Diabetes-related Executive Functioning Scale- short form (DREFS-SF)
The change in the DREFS-SF will be measured from baseline to post-intervention (up to 11 weeks). The DREFS-SF is an 11-item self-report and parent proxy screening measure to assess behaviors related to diabetes- specific executive functioning, with higher scores indicating greater difficulty.
Measured: Baseline to post-intervention, up to 11 weeks
Diabetes-Specific Risk-Taking Inventory (DSRI)
The change in the DSRI will be measured from baseline to post-intervention (up to 11 weeks). The DSRI is a 31-item (+3 items for insulin pump users) self-report measure assessing risky T1D self-management behaviors, rated on a 6 point scale, with higher score indicating more frequent engagement in risky diabetes-related health behaviors.
Measured: Baseline to post-intervention, up to 11 weeks
Diabetes Knowledge Questionnaire (DKQ)
The change in the DKQ will be measured from baseline to post-intervention (up to 11 weeks). The DKQ is adapted from other, established diabetes knowledge questionnaires for the purpose of this study. Higher scores indicate more accurate knowledge of information related to diabetes management.
Measured: Baseline to post-intervention, up to 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start15 Feb 2024
- Primary completion14 Nov 2025 (estimated)
- Study completion14 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (T1D)Studies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 3 sequential trials of a novel behavioral intervention
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Michigan University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Nemours Children's Health System
- Responsible party
- Principal investigator, Rachel Wasserman, Western Michigan University School of Medicine
- Investigators
- Rachel Wasserman, PhD, Principal investigator, Western Michigan University Homer Stryker MD School Of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109128
- Sponsor's protocol ID
- WMED1378
- Other IDs
- 11-23-JDFBMH-03
- Status last verified
- Jul 2025
- First submitted
- 23 Apr 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified and cleaned, item-level spreadsheet data for all variables will be shared with other researchers (along with example quantifications and transformations from initial raw data) via deposit in the data sharing repositories. The rationale for sharing only cleaned data is to foster ease of data reuse. Aggregate survey datasets and summaries of debriefing sessions, containing no identifiers, data collection instruments, codebook and data dictionary, qualitative analysis protocols, and code and statistical analysis protocols will be freely available via the data sharing repository (below).
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The T1D Talks Pilot Study: An Online Teen / Tween Group About Life With T1D and Managing the Emotions That Come With it
- ClinicalTrials.gov ID
- NCT07109128
- Acronym / sponsor ID
- WMED1378
- Conditions
- Type 1 Diabetes (T1D)
- Keywords
- adolescents, emotion regulation, group, virtual
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Western Michigan University School of MedicineUniversity, hospital or other
- Collaborators
- Nemours Children's Health System
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 14 Nov 2025 (estimated)
- Study completion
- 14 Nov 2025 (estimated)
- First posted
- 7 Aug 2025 (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.
Despite recent technological advances in type 1 diabetes (T1D) treatment, adolescents are the only age group for which glycemic levels have not improved. Technology and education help adolescents execute the mechanics of managing blood glucose levels, but do not help adolescents manage the emotional distress that arises when T1D management goals conflict with social/emotional goals (e.g., taking insulin for a meal in front of new friends vs. trying to "fit-in"). The emotional distress caused by such situations can be difficult to manage and can lead to unhealthy risk behaviors and disengagement in T1D self-management (e.g., deciding to skip a lunch-time bolus to avoid bolusing in front of new friends).
A novel approach in T1D research is to target emotions directly by promoting emotion regulation skills. In the general population, emotion regulation interventions have demonstrated success in preventing both unhealthy behaviors and mood disorders among younger adolescents, including younger adolescents with social-emotional risk-factors like low SES. The investigators' scientific premise is that an emotion regulation intervention for younger adolescents with T1D (age 12-14) could promote skills to help youth manage emotional burdens of living with T1D, reduce unhealthy and risky T1D self-management behaviors, and prevent unhealthy patterns of behaviors and distress/mood disorders that often appear in later adolescence.
Using the ORBIT Model, a systematic framework for developing behavioral interventions for people with chronic diseases, the investigators adapted an evidence-based, manualized emotion regulation intervention for young adolescents, so that it is relevant for youth with T1D. The current study is a natural extension of this previous work. For the current study, the investigators propose to complete a feasibility and acceptability trial of this novel emotion regulation intervention for youth with T1D.
The investigators aimed to pilot the novel emotion regulation intervention (11 virtual group sessions) with 3 sequential groups of 6-8 young adolescents (age 12-14) with T1D in each group and obtain feedback from facilitators and participants and their parents after each session, and after the intervention.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 3 sequential trials of a novel behavioral intervention
| Arm | Type | Receives |
|---|---|---|
| The T1D Talks Virtual Group Intervention for Teens and Tweens with T1D | Experimental | Behavioral: The T1D Talks: A Virtual Group for Teens and Tweens with T1DExperimental: The T1D Talks Group Intervention. This is the intervention, as this is a proof of concept pilot study, we will only have an intervention arm. |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- T1D for at least 1 year
- the ability to read/write and converse in English
- reliable internet connection and a virtual meeting capable device (tablet or laptop)
Key exclusion criteria (2 listed)
- a chronic medical condition that requires intensive daily management
- a significant mental health or cognitive disability that would prevent them from participating
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 |
|---|---|---|
| The T1D Talks: A Virtual Group for Teens and Tweens with T1DThe T1D Talks intervention is an 11 session, virtual (online), group intervention. The T1D Talks intervention teaches developmentally appropriate emotion regulation (ER) skills and facilitates practicing these skills via role-plays and in-session experiences that are meant to elicit strong emotions. The investigators adapted the content and situations of an established intervention to be relevant for youth with T1D (e.g., practicing ER skills while role playing situations like telling parents about high blood glucose numbers or telling a coach about needing to take a time out from a game because of a low blood glucose level). The intervention also provides basic diabetes education about risky situations (e.g., how physical activity can affect blood glucose). | Behavioural | The T1D Talks Virtual Group Intervention for Teens and Tweens with T1D |
Primary outcome
Percent of participants who attended the intervention
Time frame: Through study completion, up to 12 weeks
Feasibility will be demonstrated by average individual participation in at least 70% of the sessions, and >70% of participants completing the intervention by participating in the last session.
Percent of participants who rated each session as acceptable
Time frame: Through study completion, up to 12 weeks
The percentage of participants who rated each session as "acceptable" on a post-session survey rating scales that were developed for this study. 6 items on the session evaluation survey assess the following: relevance, trust in the information, ease of understanding, learning novel information, and interest in topics. Item responses include a 5-point Likert scale from "strongly disagree to strongly agree". The research team will average participant's responses across the items, thus total score could be a minimum of 1 and a maximum of 5, with a higher score indicating higher acceptability of the intervention. The intervention will be considered acceptable if ≥ 70% of participants rate each session as acceptable, as indicated by a total score >3.
Percent of participants who rated the overall intervention as acceptable
Time frame: Through study completion, up to 12 weeks
The percentage of participants who rated the intervention, as a whole, as "acceptable" on a post-intervention survey rating scales that were developed for this study. 16 items on the intervention evaluation survey assess, one's perceptions of the intervention. Item responses include a 5-point Likert scale from "strongly disagree to strongly agree". The research team will reverse score items that negatively worded and average participant's responses across the items, thus total score could be a minimum of 1 and a maximum of 5, with a higher score indicating higher acceptability of the intervention. The intervention will be considered acceptable if ≥ 70% of participants rate the intervention as acceptable, as indicated by a total score >3.
9 secondary outcomes
Difficulties in Emotion Regulation- Short Form Scale
Time frame: Baseline to post-intervention, up to 11 weeks
Emotion Regulation Behaviors Scale (ERBS-R)
Time frame: Baseline to post-intervention, up to 11 weeks
Implicit Theories of Emotion Scale- Child Version (ITES-C)
Time frame: Baseline to post-intervention, up to 11 weeks
Affect Dysregulation Scale (ADS)
Time frame: Baseline to post-intervention, up to 11 weeks
Early Adolescent Temperament Questionnaire (EATQ-R select subscales)
Time frame: Baseline to post-intervention, up to 11 weeks
Problem Areas in Diabetes: Teen (PAID-T)
Time frame: Baseline to post-intervention, up to 11 weeks
Diabetes-related Executive Functioning Scale- short form (DREFS-SF)
Time frame: Baseline to post-intervention, up to 11 weeks
Diabetes-Specific Risk-Taking Inventory (DSRI)
Time frame: Baseline to post-intervention, up to 11 weeks
Diabetes Knowledge Questionnaire (DKQ)
Time frame: Baseline to post-intervention, up to 11 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: Yes. The de-identified and cleaned, item-level spreadsheet data for all variables will be shared with other researchers (along with example quantifications and transformations from initial raw data) via deposit in the data sharing repositories. The rationale for sharing only cleaned data is to foster ease of data reuse. Aggregate survey datasets and summaries of debriefing sessions, containing no identifiers, data collection instruments, codebook and data dictionary, qualitative analysis protocols, and code and statistical analysis protocols will be freely available via the data sharing repository (below).
Related trials for Type 1 Diabetes (T1D)
Not yet recruiting
Care COMPASS Study
Diabetes Mellitus ( Type 1 and Type 2), Hypertension
Recruiting
Starting Technology in At Risk Type 1 Diabetes Study
Diabetes Mellitus, Type 1
Active, not recruiting
Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes
Type 2 Diabetes, Osteoporosis
Not yet recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAL-119 in Healthy Volunteers and Adult Participants With Type 1 or Type 2 Diabetes
Healthy Volunteers and Diabetes Participants
RecruitingPhase 4
Cholesterol Lowering and Residual Risk in Diabetes, Type 1
Type 1 Diabetes
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.
Rachel Wasserman, PhD principal investigator
Western Michigan University Homer Stryker MD School Of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The T1D Talks: A Virtual Group for Teens and Tweens with T1D in people with Type 1 Diabetes (T1D), run by Western Michigan University School of Medicine 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 3 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: enrolling by invitation, as of the sponsor's last update on 7 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Percent of participants who attended the intervention (time frame: Through study completion, up to 12 weeks). 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 7 Aug 2025.