Type 1 Teamwork: A Tool for Parents of Adolescents With Type 1 Diabetes

NCT04073914 | Completed

• 1 other identifier: 5R44DK098857
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 2

Brief Summary

Type 1 Diabetes (T1DM) is a common chronic illness in children which presents difficult and often stressful management concerns for parents. As children approach adolescence, this burden increases with the desire for independence and self-management. No tool exists that addresses in a user friendly, easy to access and socio-culturally appropriate way, the psychosocial needs of parents as they move through this transition. This program targets the parents to help them at the very point where this transition is occurring.

Conditions

Type1diabetes; Type1 Diabetes Mellitus

Keywords

Diabetes; Adolescence; Parents

Outcome Measures

Primary Outcomes (1)

• Change in Parent Stress using the Perceived Stress Scale (PSS)

  Participants of the Type1Teamwork program will have a significant decrease in parent stress compared to the control arm participants at 3 and 6 month follow-up. The researchers are using the PSS, a 14-item scale that measures a person's perceived stress by considering the degree to which situations in one's life are appraised as stressful. Items evaluate how unpredictable, uncontrollable, and overloaded respondents find their lives. Higher scores indicate greater perceived stress. Chronbach's alpha was 0.89 in our sample. REF: Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. Journal of health and social behavior. Dec 1983;24(4):385-396.

  Baseline, 3 months, and 6 months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Type 1 Teamwork program

Behavioral: Type 1 Teamwork Program

Control

NO INTERVENTION

Standard of care

Interventions

Type 1 Teamwork Program BEHAVIORAL

Psychoeducational web program

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Parent of an adolescent with T1D aged 11-16;
• Able to comply with the terms of the trial (available time commitment);
• Able to speak, read, and write in English

Sponsors & Collaborators

• Carelon Research: lead
• Yale University: collaborator

Study Sites (2)

Yale University

New Haven, Connecticut, 06510, United States

Location

New England Research Institutes

Watertown, Massachusetts, 02472, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Lisa Marceau, MPH

  Carelon Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: To evaluate the complete program the investigators conducted a modest randomized clinical trial, randomizing parents to the Type1Teamwork program or a wait-list control group. Results were analyzed using general linear repeated measures models with training group, and time as fixed effects. The primary hypotheses comparing changes in domain totals over time will be tested by the interaction effect of time by treatment group.

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: August 29, 2019
• Study Start: June 29, 2017
• Primary Completion: March 26, 2018
• Study Completion: March 26, 2018
• Last Updated: August 29, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)