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Type 1 DiabetesEMPoWERNCT06014879

EMPoWER Study - Strengths-based Behavioral Intervention for Youth With Type 1 Diabetes

A study testing Type 1 Doing Well (T1DW) Program and Diabetes-Related Information and Resources Program in people with Type 1 Diabetes, run by Baylor College of Medicine at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The EMPoWER Study randomized clinical trial is a strengths-based behavioral intervention delivered to youth with type 1 diabetes (age 10 to 13) and their parents. The purpose of the intervention is to improve glycemic, behavioral, and psychosocial outcomes in youth with diabetes using a multiple systems approach that… Read more about this study

Who is it for?
Ages 10 to 99 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
Type 1 Doing Well (T1DW) Program and Diabetes-Related Information and Resources Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
1 siteUnited States
Study dates
22 Oct 2024to 31 Dec 2027
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 10 to 99 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Youth
  • type 1 diabetes diagnosis per ADA criteria for at least 6 months,
  • age 10 to 13 years at consent,
  • English or Spanish fluency,
  • At least one hemoglobin A1c value ≥ 7.5 % (percent) within the past 12 months (changed from ≥8.0% in March 2026)
  • Patient at one of the participating study sites
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  • Parent/legal guardian of youth
  • Age at least 18 years old at time of consent,
  • English or Spanish fluency,
  • Consistent access to a mobile phone that has texting capabilities and a device with internet access
  • self-reported type 1 diabetes diagnosis for ≥ 1 year,
  • age 14-17 at consent,
  • English fluency,
  • living in the United States
  • Provider at one of the sites' diabetes care centers

Who cannot join

  • Youth
  • Being treated for:
  • a major serious or acute medical condition or comorbidity (e.g. cancer, cystic fibrosis),
  • a major serious psychological or psychiatric condition,
  • a major serious developmental condition that would interfere with capacity for informed assent or participation or that would confound outcomes
  • Parents/legal guardian of youth participant
Show all 18Show fewer
  • Being treated for:
  • a major serious or acute medical condition or comorbidity (e.g. cancer, cystic fibrosis),
  • a major serious psychological or psychiatric condition,
  • a major serious developmental condition that would interfere with capacity for informed consent or participation or that would confound outcomes
  • Other Exclusion Criteria
  • Plans to move diabetes care out of participating hospital site within next 6 months,
  • Legal guardianship of the youth with diabetes being unclear at the time of screening or recruitment,
  • Study team learning of other involvement with the legal system during screening or recruitment
  • For the Teen Videos:
  • major psychiatric or developmental disorders in youth or parents that would interfere with capacity for informed consent or participation,
  • major medical comorbidities that would confound outcomes (e.g., cancer, cystic fibrosis).
  • Diabetes Care Provider Participants

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Baylor College of Medicine

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Strengths-Based Multi-Level Behavioral Intervention to Promote Resilience and Self-Management in Youth With Type 1 Diabetes

The EMPoWER Study randomized clinical trial is a strengths-based behavioral intervention delivered to youth with type 1 diabetes (age 10 to 13) and their parents. The purpose of the intervention is to improve glycemic, behavioral, and psychosocial outcomes in youth with diabetes using a multiple systems approach that engages youth, their parents, and diabetes care providers to identify and build youths' diabetes strengths. The primary aim of this study is to assess the intervention impact on glycemic control, adherence, and health-related quality of life (HRQOL). Secondary aims are to evaluate behavioral mediators of intervention impact and to examine intervention dose as a mediator of intervention impact.

Read the detailed description

The goal of the randomized clinical trial (RCT) is to learn if a brief behavioral intervention targeting multiple systems ("Type 1 Doing Well" Program) can improve glycemic, behavioral, and psychosocial outcomes in youth with type 1 diabetes. Youth, age 10 to 13, will enroll with one parent or legal guardian to participate in the study with them. Researchers will compare the Type 1 Doing Well (T1DW) Program arm to the Enhanced Usual Care (EUC; "Diabetes-Related Information and Resources" Program) arm.

Parent-youth dyads in both study arms will provide data (e.g. questionnaires, A1c, medical chart and diabetes device data) at four timepoints throughout the duration of the study. Following baseline data collection, parent-youth dyads will complete an orientation session with study team members to be randomized to their study arm and review study activities. Parent and youth will also be invited to complete a feedback interview on their experience with the program they received.

The intervention will take place during the 6-month intervention period, and participants will be randomly allocated to 1 of two intervention conditions:

  1. Parents and youth in the T1DW Program condition (intervention) will use a web-based mobile application to do daily and weekly activities focused on recognizing and reinforcing youths' diabetes strengths. They will also have a conversation with the youth's diabetes provider about what is going well in diabetes care at a routine diabetes appointment.
  2. Parents and youth in the EUC Program condition will receive and review 6 monthly diabetes-related information and resources in the form of electronic handouts.

In preparation for the randomized clinical trial of a new behavioral intervention for preteens with type 1 diabetes and their parents, the study is also enrolling adolescents with type 1 diabetes to create videos about living well with type 1 diabetes. The videos will be used in the intervention materials for the randomized clinical trial.

Diabetes care providers at each of the sites will also be enrolled in the study. Provider participants will receive a brief training to deliver the strength-based conversation with parent-youth dyads in the T1DW Program arm, and they will complete study-related questionnaires about their experiences delivering the strengths-based conversation component of the intervention.

Conditions
Type 1 Diabetes
Being tested
Type 1 Doing Well (T1DW) Program, Diabetes-Related Information and Resources Program
Keywords
type 1 diabetes, youth, adolescent, child, positive psychology, mhealth, ehealth
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.

  • Type 1 Doing Well (T1DW) ProgramBehavioural

    Parent and youth will each have access to a version of the app. The study app activities include parents and youth:

    • noticing what the youth does well for diabetes;
    • setting and tracking a family diabetes goal in the app; and
    • having a weekly meeting to review what the youth is doing well with diabetes and progress on the family diabetes goal.

    Parents and youth will also have access to age-appropriate libraries of videos with diabetes-specific content.

    Parents and youth will also have a conversation with the youth's diabetes care provider at a regularly scheduled diabetes appointment at participating hospital sites.

  • Diabetes-Related Information and Resources ProgramOther

    Also called Enhanced Usual Care (EUC) Program

    Parent and youth will receive diabetes-related information and resources in the form of electronic handouts. They will receive one handout per month by email during the 6-month intervention period. These handouts include a variety of diabetes-related topics curated by the study team. Handouts will not include any specific information about the youth's health.

Study groups in NCT06014879
Study groupRoleWhat they receive
Type 1 Doing Well (T1DW) ProgramExperimentalYouth with type 1 diabetes (ages 10-13) and their parents or legal guardians who are receiving care from enrolled diabetes care providers will be randomized to either the T1DW Program or the EUC Program. After being randomized to the T1DW Program at the orientation session, parents and youth will receive an overview of the web-based mobile application and intervention activities that they will engage with for 6 months. The app-based intervention activities include brief daily use of the app for parents to recognize and reinforce their child's positive diabetes-related behaviors, brief weekly activities for parents and youth to reflect on and discuss what the child has done well for diabetes, family diabetes goal-setting, and videos for parents and youth about living well with T1D. Parents and youth will also engage in a brief strengths-based conversation with their diabetes care provider at one medical appointment during the study period.
Receives: Behavioral: Type 1 Doing Well (T1DW) Program
Diabetes-Related Information and Resources Program (Enhanced Usual Care; EUC)Active comparatorYouth with type 1 diabetes (ages 10-13) and their parents or legal guardians who are receiving care from enrolled diabetes care providers will be randomized to either the T1DW Program or the EUC Program. After being randomized to the EUC Program at the orientation session, parents and youth will receive monthly email handouts with diabetes-related information and resources for 6 months.
Receives: Other: Diabetes-Related Information and Resources Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Demographic and Medical Information Questionnaire

    Only demographic information and limited diabetes treatment information will be collected about participants in the teen videos portion of this study. Participants will complete a brief questionnaire developed by the study team, which will request self-reported information about participant demographics (e.g., race, ethnicity, gender) and medical information (e.g., time since diabetes diagnosis, current treatments).

    Measured: Baseline

  2. Glycemic Control - HbA1c

    Point of care HbA1c values documented by the medical team at each clinic visit will be collected from the electronic health record, to assess change in glycemic outcomes. Youth will be asked to complete a home dry blood spot A1c kit at three study timepoints unless an A1c value is documented in the electronic health record within the required timeframe. The study team will mail youth a home kit with instructions, all necessary materials to collect the sample, and a pre-paid mailer to ship it back. Higher HbA1c indicates higher average blood glucose values over the previous 2-3 months, which represents poorer glycemic control.

    Measured: Baseline, 6 months, 12 months

  3. Glycemic Control - time-in-range

    When available for youth who use a continuous glucose monitor (CGM), 14 days' of CGM data will be downloaded at each time point by the study teams to calculate glucose time-in-range as an additional index of glycemic control. Higher time-in-range is an indicator of better glycemic control.

    Measured: Baseline, 3 months, 6 months, and 12 months

  4. Adherence - Self-Care Inventory 2 (SCI-2)

    Parents and youth will complete the Self-Care Inventory 2 (SCI-2) Short Form. The form was adapted/shortened by the study team with permission from the original author, with validation paper forthcoming. Higher scores indicate higher adherence/more engagement in diabetes self-management behaviors.

    Measured: Baseline, 3 months, 6 months, and 12 months

  5. Health-Related Quality of Life (HRQOL)

    Parents and youth willcomplete the age- and respondent-appropriate version of the Type 1 Diabetes and Life (T1DAL) measure. Psychometric data regarding the validity and reliability of the pediatric, adult, and parent/partner versions of the T1DAL are published. Total scores are on a 100-point scale, with higher scores indicating better quality of life.

    Measured: Baseline, 3 months, 6 months, and 12 months

Secondary outcomes (8)

  1. Diabetes Distress

    Parents and youth will complete the age- and respondent-appropriate version of the Problem Areas in Diabetes (PAID) scale (children, adolescents, and parents). Higher scores on the measure indicate more distress.

    Measured: Baseline, 3 months, 6 months, and 12 months

  2. Diabetes Strength

    The Diabetes Strengths and Resilience (DSTAR) measure assesses youths' self-perceptions about what they do well with diabetes (known as diabetes strengths). Youth will rate how often the items represent their experiences/perspectives about their diabetes strengths. Items responses range from 0 (never) to 4 (almost always) and are calculated for total and subscale scores (higher = more strengths).

    Measured: Baseline, 3 months, 6 months, and 12 months

  3. Positivity Scale

    The Positivity Scale assesses the tendency to view life and experiences with a positive outlook. Parents respond to an 8-item measure on a scale from 1 (Strongly Disagree) to 5 (Strongly Agree) and are calculated for total scores (higher = more positivity).

    Measured: Baseline, 3 months, 6 months, and 12 months

  4. Role Overload

    The Role Overload questionnaire is a 6-item scale that assess parents' self-perceptions about role overload they are experiencing. Parents indicate how often they feel role overload on a scale from 1 (Never) to 7 (Always) and are calculated for total scores (higher = more role overload).

    Measured: Baseline, 3 months, 6 months, and 12 months

  5. Family Conflict - Diabetes Family Conflict Scale - Revised (DFCS)

    The Diabetes Family Conflict Scale-Revised (DFCS) is a 19-item scale assessing parent and youth perceptions of disagreements related to diabetes care. This measure has been used extensively with youth with diabetes and parents of youth with diabetes and is valid and reliable.

    Measured: Baseline, 3 months, 6 months, and 12 months

  6. Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Positive Affect 15a Items

    The PROMIS Short Form Positive Affect 15a assesses momentary positive or rewarding affective experiences. Youth respond to 3 items on a scale from 1 (Never) to 5 (Always) and are calculated into a total score (higher = more positive affect).

    Measured: Baseline, 3 months, 6 months, and 12 months

  7. PROMIS Short Form Family Relationships 4a Items

    The PROMIS Short Form Family Relationships 4a assesses the subjective (affective, emotional, cognitive) experience of being involved with one's family. Youth respond to 6 items on a scale from 1 (Never) to 5 (Always) and are calculated into a total score (higher = more family support).

    Measured: Baseline, 3 months, 6 months, and 12 months

  8. Satisfaction Questionnaire

    Parents and youth will complete a satisfaction survey both post-intervention and at 12-month follow-up to rate their experiences in the study while the intervention group will also rate the usefulness of and their satisfaction with the intervention components mid-intervention.

    Measured: 3 months, 6 months, and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2023
  2. Study start22 Oct 2024
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
Model description
For the first phase of this project, all teen participants (up to 40 total) will create videos about living well with type 1 diabetes. The videos will be used in the upcoming randomized clinical trial of the new intervention. For the randomized control trial, a parallel two group design will be used to evaluate the intervention among n=250 parents and youth dyads assigned to the Type 1 Doing Well intervention condition or the enhanced usual care condition (1:1). All parent and youth dyads are randomized to either the Type 1 Doing Well intervention condition or the enhanced usual care condition. Parents and youth dyads will be in the the study for approximately 12 months. Providers (up to 20 per site, 40 total) will also be enrolled as participants to deliver the provider conversation intervention to parent and youth dyads randomized to the intervention condition, and to provide data about their experiences.
Masking
None (open label)
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06014879
Sponsor's protocol ID
H-51765
Acronym
EMPoWER
Status last verified
Sep 2026
First submitted
16 Aug 2023
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will only be available within study team. Participants in the teen videos may be identified by showing face within videos, and participants sign consent form and institutional media release forms.

Questions about this trial

What is this clinical trial studying?

A study testing Type 1 Doing Well (T1DW) Program and Diabetes-Related Information and Resources Program in people with Type 1 Diabetes, run by Baylor College 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 15 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 14 Sep 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?

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?

Demographic and Medical Information Questionnaire (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06014879.

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 14 Sep 2026.

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