Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Strengths-Based Behavioral mHealth App for Parents of Adolescents With Type 1 Diabetes-Pilot Study (T1DoingWell)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02877680
Recruitment Status : Completed
First Posted : August 24, 2016
Results First Posted : June 9, 2020
Last Update Posted : September 24, 2020
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Feinberg School of Medicine, Northwestern University
United States Department of Agriculture (USDA)
Information provided by (Responsible Party):
Marisa Hilliard, Baylor College of Medicine

Brief Summary:
Type 1 diabetes (T1D) management is particularly challenging during adolescence as responsibility for management begins to shift from parents to youth, and positive family teamwork is critical to achieving optimal diabetes outcomes. Existing behavioral family interventions for T1D are beneficial but have limited potential for translation to clinical practice, and universal preventive approaches designed to explicitly promote existing T1D management strengths are needed. Ultimately, the goal of this line of research is to validate brief, convenient, and helpful tools that families of all adolescents with T1D can use to strengthen positive family teamwork and ultimately promote optimal diabetes health outcomes.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Behavioral: T1Doing Well Not Applicable

Detailed Description:
Type 1 diabetes (T1D) is among the most common chronic conditions of childhood and its management is complex and relentless. Adolescents have increased risk for worsening glycemic control, putting them at risk for short- and long-term complications. As responsibility for daily T1D management tasks begins to shift from parents to youth, supportive parent-adolescent teamwork promotes optimal diabetes outcomes. However, adolescents' cognitive development, desire for autonomy, and changing family and social relationships can make adherence to treatment recommendations difficult and strain attempts at parent-adolescent teamwork. This study aims to develop and pilot test a mobile app-based behavioral intervention to facilitate positive, supportive parent-adolescent interactions around T1D management. The proposed study has two parts. First, adolescents with T1D (age 12-17), their parents, and diabetes care providers will be invited to participate in designing a smartphone app that supports parents to recognize, keep track of, and reinforce their adolescents for specific positive T1D-related behaviors, or strengths. Example strengths include asking for help with complicated diabetes tasks, talking to friends about diabetes, and expressing confidence or optimism about T1D management. Intermittently throughout the day, the app will push parents a prompt to report which positive T1D behaviors their adolescent has engaged in. The app will generate weekly summary reports of each adolescent's most frequent strength behaviors, and parents will be reminded via the app to praise their adolescent for those patterns. Second, this intervention will be pilot tested with 82 families; parents will be randomized to an intervention or a control condition. Participants in the intervention condition will use the app for 3-4 months and provide feedback, and control participants will receive usual care and will not use the app. The main goal is to determine how often and in what ways families use the app, whether they like it, and to obtain suggestions for improvement. Trends for impact on important diabetes outcomes, such as quality of parent-adolescent relationships, T1D treatment adherence, and glycemic control will also be evaluated. Data - including questionnaires, adherence data from blood glucose meters, and glycemic control biomarkers from a blood draw - will be collected at baseline and again 3-4 months later. The results of this pilot study will help refine the intervention so that it can be evaluated in a fullscale randomized controlled trial. Ultimately, the goal of this research is to validate brief, convenient, and helpful tools that families of all adolescents with T1D can use to strengthen positive family teamwork and ultimately promote optimal diabetes health outcomes.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development and Pilot of a Strengths-Based Behavioral mHealth Intervention to Promote Resilience in Adolescents With Type 1 Diabetes
Actual Study Start Date : July 31, 2017
Actual Primary Completion Date : May 30, 2019
Actual Study Completion Date : May 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Intervention
Smartphone app for parents to track adolescents' strength behaviors related to living with and managing type 1 diabetes, including regular feedback to parents and training about how to recognize and reinforce positive behaviors in teens.
Behavioral: T1Doing Well
Strengths-based mobile health (mHealth) app for parents of adolescents with type 1 diabetes, which will prompt parents to recognize and reinforce their adolescents' diabetes-related strength behaviors

No Intervention: Usual Care
Usual diabetes care and study-related data collection, without use of app during the study period. They will be offered an opportunity to try the app and share their feedback with the study team after completing follow-up data collection.



Primary Outcome Measures :
  1. Feasibility of Study Design - Recruitment Rate [ Time Frame: Immediately following enrollment (baseline timepoint) ]
    Recruitment data measured by percent of recruited families that enrolled in study.

  2. Feasibility of T1Doing Well App - Engagement With App At Least Twice A Week [ Time Frame: 3-4 months after enrollment (follow-up timepoint) ]
    Feasibility of the app measured by percentage of participants that engaged with or used the app at least twice a week during the intervention period.

  3. Acceptability of T1Doing Well App (Survey) [ Time Frame: 3-4 months after baseline (follow-up timepoint) ]
    Participants in the intervention arm completed the Usefulness, Satisfaction, and Ease of Use Questionnaire (USE), a measure of the users' perceived usefulness of, satisfaction with, and ease of use of a particular technology. The item scale ranges from the minimum to maximum possible score is 1-7, with a higher score representing a better outcome. Acceptability measured as percentage of participants who selected a score of at least 4 (out of 7) on the item "I am satisfied with it," indicating it was at least somewhat acceptable.

  4. Acceptability - Number of Participants That Felt The Intervention Was Well-Received [ Time Frame: 3-4 months after baseline (follow-up timepoint) ]
    The number of participants that felt the intervention was well-received was collected for Adolescents and Parents. To determine if the intervention was well-received, verbal responses from qualitative interviews with were coded for types of participant feedback by the study team. We coded these data qualitatively and classified them as Positive, Negative, or Neutral. Positive responses indicate the intervention was well-received.


Secondary Outcome Measures :
  1. Adherence to Diabetes Regimen (Objective) - Blood Glucose Monitoring Frequency [ Time Frame: 3-4 months after baseline (follow-up timepoint) ]
    Objective measurement of adherence to diabetes regimen measured by blood glucose monitoring frequency (a well-accepted surrogate of overall adherence), obtained via blood glucose meter downloads. The average daily frequency was calculated over the 14 days prior to the assessment at the baseline visit.

  2. Glycemic Control - HbA1c [ Time Frame: 3-4 months after baseline (follow-up timepoint) ]
    At the time of this study, the American Diabetes Association generally recommended an HbA1c target of <7.0% (it was <7.5% at the time this study took place, for individuals younger than 18 years. The especific target varies depending on the individual). The DCA 2000 HbA1c Analyzer (Siemens-Bayer) was used for point of care HbA1c analysis, it has an analytical measurement range for HbA1c of 2.5% to 14.0%. HbA1c values are collected via fingerstick and blood assay at routine diabetes care visits and values were extracted from the medical record at each clinic visit during the study period.

  3. Diabetes Family Impact - Diabetes Family Impact Scale (DFIS), Parent-report [ Time Frame: 3-4 months after baseline (follow-up timepoint) ]
    Diabetes-specific family impact was measured using the Diabetes Family Impact Scale (DFIS), a 15-item measure of the impact of diabetes on family members' activities and relationships. The scale range from the minimum to maximum possible score is 0-100. A higher score represents a better outcome.

  4. Family Impact - Pediatric Quality of Life Impact Module (Peds QL-FI), Parent-report [ Time Frame: 3-4 months after baseline (follow-up timepoint) ]
    Family impact was measured using The Pediatric Quality of Life Family Impact Module (Peds QL-FI), a 36-item measure of the impact of parenting a child with a chronic medical condition on family functioning and parent QOL. The scale range from the minimum to the maximum score is 0-100. A higher score represents a better outcome.

  5. Family Communication - Helping for Health Inventory (HHI), Parent-report [ Time Frame: 3-4 months after baseline (follow-up timepoint) ]
    Family communication was measured by the parent-report Helping for Health Inventory (HHI), a 15-item questionnaire assessing perceptions of parental help around the teen's diabetes management. The scale range from the minimum to maximum possible score is 15-75. A lower score represents a better outcome.

  6. Family Communication - Helping for Health Inventory (HHI), Adolescent-report [ Time Frame: 3-4 months after baseline (follow-up timepoint) ]
    Family communication was measured using the adolescent-report Helping for Health Inventory (HHI), a 15-item questionnaire assessing perceptions of parental help around the teen's diabetes management. The scale range from the minimum to maximum possible score is 15-75. A lower score represents a better outcome.

  7. Diabetes Family Conflict Scale-Revised (DFCS), Parent-report [ Time Frame: 3-4 months after baseline (follow-up timepoint) ]
    Family conflict was measured using the Diabetes Family Conflict Scale - Revised (DFCS), a measure of diabetes-specific conflict in families with adolescents with type 1 diabetes. The scale range from the minimum to maximum possible score is 19-57. A lower score represents a better outcome.

  8. Diabetes Family Conflict Scale-Revised (DFCS), Adolescent-report [ Time Frame: 3-4 months after baseline (follow-up timepoint) ]
    Family conflict was measured using the Diabetes Family Conflict Scale - Revised (DFCS), a measure of diabetes-specific conflict in families with adolescents with type 1 diabetes. The scale range from the minimum to maximum possible score is 19-57. A lower score represents a better outcome.

  9. Problem Areas in Diabetes-Teen (PAID-T), Parent-report [ Time Frame: 3-4 months after baseline (follow-up timepoint) ]
    Diabetes burden was measured using the Problem Areas in Diabetes (PAID-T) parent-report, a measure of how bothersome day-to-day problems are for parents of adolescents with type 1 diabetes. The scale range from the minimum to maximum possible score is 26-156. A lower score represents better a outcome.

  10. Problem Areas in Diabetes-Teen (PAID-T), Adolescent Self-report [ Time Frame: 3-4 months after baseline (follow-up timepoint) ]
    Diabetes burden was measured using the Problem Areas in Diabetes-Teen (PAID-T) self-report, a measure of how bothersome day-to-day problems are for adolescents with type 1 diabetes. The scale range from the minimum to maximum possible score is 26-156. A lower score represents better a outcome.

  11. Self-Management - Diabetes Self-Management Profile (DSMP), Parent-report [ Time Frame: 3-4 months after baseline (follow-up timepoint) ]
    Parent-report of adolescent self-management was measured using the 24-item Diabetes Self-Management Profile Self-Report (DSMP). Parents completed the version appropriate to their child's current diabetes regimen (conventional insulin regimen, 24 items; flexible insulin regimen, 24 items). The scale range from the minimum to maximum possible score is 0-86. A higher score represents a better outcome.

  12. Self-Management - Diabetes Self-Management Profile (DSMP), Adolescent Self-report [ Time Frame: 3-4 months after baseline (follow-up timepoint) ]
    Self-management was measured using the Self-Care Inventory-Revised (SCI-R), a 15-item measure of the frequency that adolescents engage in diabetes management behaviors on a 5-point scale from Never to Always. The scale range from the minimum to maximum possible score is 5-75. A higher score represents a better outcome.

  13. Diabetes Strengths and Resilience Measure (DSTAR), Adolescent Self-report [ Time Frame: 3-4 months after baseline (follow-up timepoint) ]
    The Diabetes Strengths and Resilience measure is a self-report assessment of positive behaviors related to diabetes resilience for youth with type 1 diabetes, such as perceived competence to manage the demanding diabetes regimen, to adapt to the unpredictability of diabetes, and to seek help and support with diabetes challenges. The scale range from the minimum to maximum possible score is 0-48. A higher value on this scale represents a better outcome.

  14. Adolescent Quality of Life - The MIND-Youth Questionnaire, Adolescent Self-report [ Time Frame: 3-4 months after baseline (follow-up timepoint) ]
    Adolescent quality of life was measured using the Monitoring Individual Needs in Diabetes Youth Questionnaire (MIND-Youth/MY-Q), a 33-item measure of diabetes-specific health-related QOL. The scale range from the minimum to maximum possible score is 0-100. A higher score represents a better outcome.

  15. Parent-Adolescent Relationship Intervention Process Measure, Adolescent Report [ Time Frame: 3-4 months after baseline (follow-up timepoint) ]

    Adolescents answered 3 items adapted from the Parent-Youth Relationship Index of the National Longitudinal Study of Youth-1997, a measure of parent-adolescent relationship quality. Item scale ranges from minimum to maximum score of 1-5 for each item, with a higher score indicating a better outcome.

    Intervention process from baseline to follow-up was analyzed using a general linear mixed model, using the item "How often does he/she praise you for doing well?" Time since first baseline clinic visit was computed and analyzed using a mixed model with time, arm, and the time-arm interaction term. The outcome measure data are reported as slopes by arm.

    *NOTE: Intervention process measures were administered biweekly, and we are reporting the calculated mean change per day with 95% confidence intervals.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of type 1 diabetes according to American Diabetes Association criteria for at least 6 months
  • Treated for type 1 diabetes at Texas Children's Hospital Diabetes Care Center
  • Parent and adolescent fluency in English
  • Parent has mobile device with data plan

Exclusion Criteria:

  • Serious medical, cognitive, or mental health comorbidity in parent or adolescent that would preclude ability to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02877680


Locations
Layout table for location information
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Feinberg School of Medicine, Northwestern University
United States Department of Agriculture (USDA)
Investigators
Layout table for investigator information
Principal Investigator: Marisa E Hilliard, PhD Baylor College of Medicine and Texas Children's Hospital
  Study Documents (Full-Text)

Documents provided by Marisa Hilliard, Baylor College of Medicine:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Marisa Hilliard, Assistant Professor of Pediatrics, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02877680    
Other Study ID Numbers: H-37311
1R21DK107951 ( U.S. NIH Grant/Contract )
First Posted: August 24, 2016    Key Record Dates
Results First Posted: June 9, 2020
Last Update Posted: September 24, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual health data will be collected that is not already available to families through their electronic medical record

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marisa Hilliard, Baylor College of Medicine:
Strengths-based
Mobile Health (mHealth)
Adolescence
Resilience
Family
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases