Type 1 Diabetes (T1D)ASSISTEDNCT06752369
Adapting Single Sessions Interventions for Type 1 Diabetes
A study testing T1D-specific depression SSI and T1D Educational in people with Type 1 Diabetes (T1D), run by Nemours Children's Health System at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if implementing a single-session depression intervention for youth with type 1 diabetes (T1D) is feasible and acceptable to patients. can help improve mood and health outcomes. It will also learn about the initial efficacy of the intervention. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Type 1 Diabetes (T1D)
- What is being tested?
- T1D-specific depression SSI and T1D Educational
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2026to Feb 2029
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child or adolescent age between 11-18 years, inclusive
- Physician confirmed T1D diagnosis of at least 6 months duration prior to study enrollment
- Positive depression screening score of >5 on the PHQ-9 in the last year
- Not currently engaged in outpatient mental healthcare
- English fluency
Who cannot join
- Another systemic chronic medical illness except for celiac disease, autoimmune thyroiditis, microalbuminuria, hypertension, or well-managed asthma
- Any score of 1, 2, or 3 on item 9 (indicating suicidal ideation) of the PHQ-9 in the last year.
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, 1 recruiting
- Recruiting
Nemours Children's Hospital - FL
Orlando, Florida, 32827
Alexandra Monzon, PhD, 904-603-6780, Alexandra.Monzon@nemours.org
About this study
Official title: Adapting Single Sessions Interventions for Type 1 Diabetes (ASSISTED): Integrated Pediatric Care to Reduce Depression and HbA1c
The goal of this clinical trial is to learn if implementing a single-session depression intervention for youth with type 1 diabetes (T1D) is feasible and acceptable to patients. can help improve mood and health outcomes. It will also learn about the initial efficacy of the intervention. The main questions it aims to answer are:
- Is a single-session depression intervention for youth with T1D feasible to recruit and implement?
- Is a single-session depression intervention for youth with T1D acceptable to patients (i.e., do they find it helpful)?
- Does a single-session depression intervention for youth with T1D lead to improvements in low mood?
Read more
Researchers will compare a single-session depression intervention for youth with to a education control to see if a single-session depression intervention works to improve depressive symptoms.
Participants will:
- Participate in a single-session depression intervention
- Complete questionnaires and provide a sample for A1c at a baseline, 3-month, and 6-month visit
- Complete daily questionnaires once a day for two weeks before and after the single-session depression intervention
- Conditions
- Type 1 Diabetes (T1D)
- Being tested
- T1D-specific depression SSI, T1D Educational
- Keywords
- type 1 diabetes, adolescents, depression
- Medical subject headings
- Diabetes Mellitus, Type 1, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T1D-specific depression SSIBehavioural
The T1D-specific depression SSI will include 1) psychoeducation about depression, including how behavior shapes feelings and thoughts, 2) a values assessment, where youth will identify key areas (i.e., family relationships, friendships, school, or hobbies) from which they draw (or once drew) enjoyment and meaning, and 3) the creation of an activity action plan, wherein youth identify (from pre-generated lists) and personalize (in guided exercises) three activities to target for change.
T1D EducationalBehavioural
T1D Educational Material
| Study group | Role | What they receive |
|---|---|---|
| T1D-specific depression SSI | Experimental | Single session depression intervention adapted for youth with T1D. The T1D-specific depression SSI will include 1) psychoeducation about depression, including how behavior shapes feelings and thoughts, 2) a values assessment, where youth will identify key areas (i.e., family relationships, friendships, school, or hobbies) from which they draw (or once drew) enjoyment and meaning, and 3) the creation of an activity action plan, wherein youth identify (from pre-generated lists) and personalize (in guided exercises) three activities to target for change. Receives: Behavioral: T1D-specific depression SSI |
| T1D Education | Placebo comparator | Educational material about T1D Receives: Behavioral: T1D Educational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c (HbA1c)
Proxy measure of glycemic level. HbA1c is the average blood glucose level over 3-4 months. We will use fingerstick blood samples and a valid mail-in dried blood spot kit to measure participant HbA1c levels at a central laboratory
Measured: 0, 3-months, and 6-months
Patient Health Questionnaire for Adolescents (PHQ-9)
The PHQ-9 is a well-validated and reliable measure that assesses the occurrence of nine possible depressive symptoms over the previous two weeks. Higher scores indicate greater depressive symptoms. A cut-off score of >5 will be used to characterize elevated depressive symptoms
Measured: 0, 3-months, and 6-months
Positive and Negative Affect Schedule (PANAS)
The PANAS is a 20-item measure that assesses different feelings and emotions. Items are grouped into the two subscales with 10 items each: positive affect and negative affect, with higher scores on the Positive Affect subscale indicating greater intensity of positive emotions, and higher scores on the Negative Affect subscale indicating greater intensity of negative emotions.
Measured: 7 days before and 7 days after SSI
Mood and Feelings Questionnaire (MFQ)
The MFQ is a 13-item measure that assesses depressed mood in youth. Higher scores indicate higher depressed mood.
Measured: 7 days before and 7 days after SSI
Feasibility of T1D-specific Depression SSI
We will determine feasibility by calculating study enrollment rates for the Aim 2 pilot trial. We will also assess the feasibility of the type 1 diabetes (T1D)-specific depression single-session intervention (SSI) in the qualitative interviews
Measured: Baseline and 3-months
Acceptability of Healthcare Interventions Questionnaire
The Acceptability of Healthcare Interventions Questionnaire is an 8-item measure that assesses the acceptability of healthcare interventions. Respondents rate each question on a scale of
1 (strongly disagree) to 5 (strongly agree), with higher scores indicating greater intervention acceptability.
Measured: immediately after SSI completion
Secondary outcomes (3)
Problem Areas in Diabetes- Teen (PAID-T)
The PAID-T is a 26-item measure that assesses diabetes-specific emotional distress in adolescents with T1D. Adolescents rate how much each item applies to them on a 6-point Likert scale from 1 (Not a Problem) to 6 (Serious Problem), with higher scores indicating greater distress.
Measured: 0, 3-months, and 6-months
Diabetes Family Conflict Scale- Revised (DFCS-R)
The DFCS-R is a 19-item measure that evaluates conflict between youth and their caregivers surrounding direct and indirect diabetes management tasks. Adolescents will rate how often they argue with their parents on a 3-point Likert scale ranging from 1 (Never Argue) to 3 (Always Argue), with higher scores indicating more parent-child conflict.
Measured: 0, 3-months, and 6-months
Diabetes Strengths and Resilience Measure for Adolescents (DSTAR-Teen)
The DSTAR-teen is a 12-item measure that assesses adaptive behaviors and attitudes about diabetes in adolescents with T1D. Adolescents rate how often each item occurs for them on a 5 -point Likert scale from 1 (Never) to 5 (Almost Always), with higher scores indicating greater strength and resilience.
Measured: 0, 3-months, 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start3 Aug 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionFeb 2029 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandra Monzon, Nemours Children's Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752369
- Sponsor's protocol ID
- K23DK139431
- Other IDs
- K23DK139431
- Acronym
- ASSISTED
- Status last verified
- Jul 2026
- First submitted
- 20 Dec 2024
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting Single Sessions Interventions for Type 1 Diabetes (ASSISTED): Integrated Pediatric Care to Reduce Depression and HbA1c
- ClinicalTrials.gov ID
- NCT06752369
- Acronym / sponsor ID
- ASSISTED / K23DK139431
- Conditions
- Type 1 Diabetes (T1D)
- Keywords
- type 1 diabetes, adolescents, depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Nemours Children's Health SystemUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 3 Aug 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 30 Dec 2024 (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 if implementing a single-session depression intervention for youth with type 1 diabetes (T1D) is feasible and acceptable to patients. can help improve mood and health outcomes. It will also learn about the initial efficacy of the intervention. The main questions it aims to answer are:
- Is a single-session depression intervention for youth with T1D feasible to recruit and implement?
- Is a single-session depression intervention for youth with T1D acceptable to patients (i.e., do they find it helpful)?
- Does a single-session depression intervention for youth with T1D lead to improvements in low mood?
Researchers will compare a single-session depression intervention for youth with to a education control to see if a single-session depression intervention works to improve depressive symptoms.
Participants will:
- Participate in a single-session depression intervention
- Complete questionnaires and provide a sample for A1c at a baseline, 3-month, and 6-month visit
- Complete daily questionnaires once a day for two weeks before and after the single-session depression intervention
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T1D-specific depression SSI | Experimental | Behavioral: T1D-specific depression SSISingle session depression intervention adapted for youth with T1D. The T1D-specific depression SSI will include 1) psychoeducation about depression, including how behavior shapes feelings and thoughts, 2) a values assessment, where youth will identify key areas (i.e., family relationships, friendships, school, or hobbies) from which they draw (or once drew) enjoyment and meaning, and 3) the creation of an activity action plan, wherein youth identify (from pre-generated lists) and personalize (in guided exercises) three activities to target for change. |
| T1D Education | Placebo comparator | Behavioral: T1D EducationalEducational material about T1D |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Child or adolescent age between 11-18 years, inclusive
- Physician confirmed T1D diagnosis of at least 6 months duration prior to study enrollment
- Positive depression screening score of >5 on the PHQ-9 in the last year
- Not currently engaged in outpatient mental healthcare
- English fluency
Key exclusion criteria (2 listed)
- Another systemic chronic medical illness except for celiac disease, autoimmune thyroiditis, microalbuminuria, hypertension, or well-managed asthma
- Any score of 1, 2, or 3 on item 9 (indicating suicidal ideation) of the PHQ-9 in the last year.
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-specific depression SSIThe T1D-specific depression SSI will include 1) psychoeducation about depression, including how behavior shapes feelings and thoughts, 2) a values assessment, where youth will identify key areas (i.e., family relationships, friendships, school, or hobbies) from which they draw (or once drew) enjoyment and meaning, and 3) the creation of an activity action plan, wherein youth identify (from pre-generated lists) and personalize (in guided exercises) three activities to target for change. | Behavioural | T1D-specific depression SSI |
| T1D EducationalT1D Educational Material | Behavioural | T1D Education |
Primary outcome
Hemoglobin A1c (HbA1c)
Time frame: 0, 3-months, and 6-months
Proxy measure of glycemic level. HbA1c is the average blood glucose level over 3-4 months. We will use fingerstick blood samples and a valid mail-in dried blood spot kit to measure participant HbA1c levels at a central laboratory
Patient Health Questionnaire for Adolescents (PHQ-9)
Time frame: 0, 3-months, and 6-months
The PHQ-9 is a well-validated and reliable measure that assesses the occurrence of nine possible depressive symptoms over the previous two weeks. Higher scores indicate greater depressive symptoms. A cut-off score of >5 will be used to characterize elevated depressive symptoms
Positive and Negative Affect Schedule (PANAS)
Time frame: 7 days before and 7 days after SSI
The PANAS is a 20-item measure that assesses different feelings and emotions. Items are grouped into the two subscales with 10 items each: positive affect and negative affect, with higher scores on the Positive Affect subscale indicating greater intensity of positive emotions, and higher scores on the Negative Affect subscale indicating greater intensity of negative emotions.
Mood and Feelings Questionnaire (MFQ)
Time frame: 7 days before and 7 days after SSI
The MFQ is a 13-item measure that assesses depressed mood in youth. Higher scores indicate higher depressed mood.
Feasibility of T1D-specific Depression SSI
Time frame: Baseline and 3-months
We will determine feasibility by calculating study enrollment rates for the Aim 2 pilot trial. We will also assess the feasibility of the type 1 diabetes (T1D)-specific depression single-session intervention (SSI) in the qualitative interviews
Acceptability of Healthcare Interventions Questionnaire
Time frame: immediately after SSI completion
The Acceptability of Healthcare Interventions Questionnaire is an 8-item measure that assesses the acceptability of healthcare interventions. Respondents rate each question on a scale of 1 (strongly disagree) to 5 (strongly agree), with higher scores indicating greater intervention acceptability.
3 secondary outcomes
Problem Areas in Diabetes- Teen (PAID-T)
Time frame: 0, 3-months, and 6-months
Diabetes Family Conflict Scale- Revised (DFCS-R)
Time frame: 0, 3-months, and 6-months
Diabetes Strengths and Resilience Measure for Adolescents (DSTAR-Teen)
Time frame: 0, 3-months, 6-months
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 24 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
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-specific depression SSI and T1D Educational in people with Type 1 Diabetes (T1D), run by Nemours Children's Health System 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 5 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: looking for participants now, as of the sponsor's last update on 24 Jul 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. Some participants in this study may receive a placebo. 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?
Contact Alexandra Monzon, PhD (904-603-6780, Alexandra.Monzon@nemours.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1c (HbA1c) (time frame: 0, 3-months, and 6-months). The study lists 6 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 24 Jul 2026.