NCT03845465

Brief Summary

The treatment regimen for type 1 diabetes is complex and demanding, and many adolescents experience diabetes distress related to the daily demands of diabetes care, which can cause problems with diabetes management and glycemic control. The proposed study will conduct a multisite, randomized trial to test the effects of a positive psychology intervention aimed at treating diabetes distress and improving glycemic outcomes. The potential benefits include helping adolescents achieve better glycemic control, improved self-management, and psychosocial outcomes

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 19, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

December 17, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2023

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

March 21, 2025

Completed
Last Updated

March 21, 2025

Status Verified

March 1, 2025

Enrollment Period

3.7 years

First QC Date

February 15, 2019

Results QC Date

July 29, 2024

Last Update Submit

March 3, 2025

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1c

    Hemoglobin A1c measures the amount of glucose attached to hemoglobin. It is assessed as part of regular diabetes clinic visits. The target is \<7.0%.

    3 months

Secondary Outcomes (7)

  • Diabetes Distress

    3 months

  • Primary Control Coping

    3 months

  • Secondary Control Coping

    3 months

  • Disengagement Coping

    3 months

  • Positive Affect

    3 months

  • +2 more secondary outcomes

Study Arms (2)

Education

ACTIVE COMPARATOR

Participants in the Education group will complete a behavioral health contract and will receive an educational packet.

Behavioral: Education

PA + Education

EXPERIMENTAL

Participants in the Positive Affect + Education group will complete a behavioral health contract and receive an educational packet. In addition, they will receive intervention components aimed at inducing positive affect.

Behavioral: Positive Affect + EducationBehavioral: Education

Interventions

Positive Affect + EducationBEHAVIORAL

Adolescents will complete a health behavior contract and receive an educational packet at baseline. Adolescents will complete a positive affect interview at baseline. They will receive automated text messages 5 days/week for 8 weeks. Messages will be tailored to include adolescents' responses to the baseline interview, including reminders to engage in gratitude and self-affirmation. Additionally, to induce positive mood they will be texted gift cards codes valued at $5.00. Further, caregivers will be asked to provide weekly positive affirmations to their adolescents, focused on non-diabetes strengths.

PA + Education
EducationBEHAVIORAL

Adolescents will complete a health behavior contract and receive an educational packet with information about diabetes management.

EducationPA + Education

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 13-17
  • Diagnosed with type 1 diabetes for at least 12 months
  • Speak and read English
  • Report at least moderate diabetes distress on the Problem Areas in Diabetes Scale - Teen version

You may not qualify if:

  • \- Other serious health conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's National

Washington D.C., District of Columbia, 20010, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

  • Straton E, Anifowoshe K, Moore H, Streisand R, Jaser SS. Associations of Coping Strategies With Glycemic and Psychosocial Outcomes Among Adolescents With Type 1 Diabetes Experiencing Diabetes Distress. Ann Behav Med. 2024 Aug 7;58(9):628-633. doi: 10.1093/abm/kaae028.

    PMID: 39014980DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Results Point of Contact

Title
Sarah Jaser, PhD
Organization
Vanderbilt University Medical Center
sarah.jaser@vumc.org
6153436775

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 15, 2019

First Posted

February 19, 2019

Study Start

December 17, 2019

Primary Completion

August 23, 2023

Study Completion

September 7, 2023

Last Updated

March 21, 2025

Results First Posted

March 21, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)