Check It! 2.0: Positive Psychology Intervention for Adolescents With Type 1 Diabetes

NCT02984709 | Completed Results DMC

• 1 other identifier: 161732
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The treatment regimen for type 1 diabetes is complex and demanding, and many adolescents have problems with adherence. The proposed study will pilot test a positive psychology intervention for adolescents with type 1 diabetes aimed at improving adherence to treatment based on feedback from the first iteration of the intervention. The potential benefits include helping adolescents achieve better glycemic control, thereby reducing the health risks and complications associated with diabetes.

Conditions

Type1diabetes

Outcome Measures

Primary Outcomes (1)

• Glycemic Control (A1C)

  A1C is the percentage of glycosylated hemoglobin and represents an average of glycemic control over the previous 2-3 months.

  3 months

Secondary Outcomes (8)

• Positive Affect

  3 months

• Frequency of Blood Glucose Monitoring

  3 months

• Diabetes Family Conflict Scale

  3 months

• Diabetes-Specific Quality of Life

  3 months

• Primary Control Coping

  3 months

Study Arms (2)

Positive Psychology Intervention

EXPERIMENTAL

The text message group will receive the intervention components via text message. They will be instructed to think about things that make them feel good when they are struggling with diabetes management (i.e. gratitude). Also they will be instructed to think about a positive value when they are in a situation that makes it hard to check their blood sugar (i.e. 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. All adolescents will be given developmentally-appropriate diabetes education material at the time of enrollment.

Behavioral: Positive Psychology Intervention

Education Group

ACTIVE COMPARATOR

The education group will be given developmentally-appropriate diabetes education material at the time of enrollment.

Behavioral: Education

Interventions

Positive Psychology Intervention BEHAVIORAL

Health Behavior Contract - Baseline visit Education Packet - Baseline visit Positive psychology training for teen and parents - baseline visit Parent praise reminder (text message) - one time per week (over 8 week intervention period) Teen gratitude message (text message) - every Monday (over 8 week intervention period) Teen positive value message (text message) - every Wednesday (over 8 week intervention period) Teen mood booster (text message) - every Thursday and Saturday and alternative Sundays (over 8 week intervention period) Small gift ($5 gift card code sent every 2 weeks for 8 weeks)

Also known as: Check It 2.0

Positive Psychology Intervention

Education BEHAVIORAL

Health Behavior Contract - Baseline visit Education Packet - Baseline visit

Education Group

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Adolescents will be eligible if they are:
• between the ages of 13-17;
• have been diagnosed with type 1 diabetes for at least 1 year;
• have no other major health problems;
• are not currently participating in any other intervention studies;
• have a glycosylated hemoglobin level between 7.5 - 12% on date of enrollment;
• are patients of the Eskind Diabetes Clinic
• must read and write in English
• and must live the caregiver that is participating in the study with them

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Results Point of Contact

• Title: Sarah Jaser
• Organization: Vanderbilt University Medical Center

sarah.jaser@vanderblit.edu

615-343-6775

Study Officials

• Sarah Jaser, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 30, 2016
• First Posted: December 7, 2016
• Study Start: October 1, 2016
• Primary Completion: February 24, 2017
• Study Completion: August 10, 2017
• Last Updated: April 24, 2019
• Results First Posted: April 24, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)