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NCT Number: NCT06752369

Adapting Single Sessions Interventions for Type 1 Diabetes

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:

1. Is a single-session depression intervention for youth with T1D feasible to recruit and implement? 2. Is a single-session depression intervention for youth with T1D acceptable to patients (i.e., do they find it helpful)? 3. 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

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Key information

Conditions

Type 1 Diabetes (T1D) Autoimmune Diseases Behavior Behavioral Symptoms Depression Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nemours Children's Hospital - FL

Orlando, Florida, 32827, United States

Location status: Recruiting

Location contact

Alexandra Monzon, PhD

CONTACT

[email protected]

904-603-6780

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

T1D-specific depression SSI

Behavioral

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 Educational

Behavioral

T1D Educational Material

Primary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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

  6. 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.

Secondary outcomes

  1. Problem Areas in Diabetes- Teen (PAID-T)

    Time frame: 0, 3-months, and 6-months

    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.

  2. Diabetes Family Conflict Scale- Revised (DFCS-R)

    Time frame: 0, 3-months, and 6-months

    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.

  3. Diabetes Strengths and Resilience Measure for Adolescents (DSTAR-Teen)

    Time frame: 0, 3-months, 6-months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra Monzon, PhD

CONTACT

[email protected]

904-603-6780

Sponsors and collaborators

Lead sponsor

Nemours Children's Health System

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Adapting Single Sessions Interventions for Type 1 Diabetes (ASSISTED): Integrated Pediatric Care to Reduce Depression and HbA1c

Acronym: ASSISTED

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Dec 30, 2024
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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