NCT04172077

Brief Summary

This project will assess self-efficacy levels(SE) ,resiliency and attachment style of adolescent with type 1 diabetes and their caregivers.SE and attachment style of patients and parents will be compared with each other as well as correlated with diabetes management as assessed by A1C and self inventory scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2018

Completed
1.5 years until next milestone

Study Start

First participant enrolled

September 18, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 21, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
Last Updated

July 8, 2021

Status Verified

July 1, 2021

Enrollment Period

4 months

First QC Date

March 9, 2018

Last Update Submit

July 7, 2021

Conditions

Keywords

Self EfficacyResiliencyAttachment style and youth with type 1 diabetes

Outcome Measures

Primary Outcomes (1)

  • Examine the effects of patients' attachment styles (secure, mixed and fearful) on their type one diabetes management represented by A1C level

    The following tool will be used - Relationship Scale Questionnaire (RSQ): The 30-item RSQ is valid and reliable. 76 Re-test reliability of the RSQ ranged from 0.54 to 0.78 and correlation coefficients of RSQ and RQ ranged from 0.41 to 0.6191. Adolescent Relationship Scale Questionnaire (A-RSQ): Sümer \& Güngör (1999) used the A-RSQ and report validity of 0.7-0.95 as well as an internal consistency of 0.82.

    25 minutes

Secondary Outcomes (4)

  • a) Effect of attachment style on self efficacy level in patients.

    25 minutes

  • a) Effect of attachment style on self efficacy level in parents.

    25 minutes

  • b)Compare diabetes management self-efficacy and attachment style in patients.

    25 minutes

  • b)Compare diabetes management self-efficacy and attachment style in parents

    25 minutes

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

T1DM patients aged 12 - 18 yrs from Sick Kids Diabetes Clinic and their primary caregiver.

You may qualify if:

  • T1DM patients age 12 - 18 yrs from Sick Kids Diabetes Clinic and a primary caregiver
  • T1DM \> 1yr and able to communicate in English

You may not qualify if:

  • Families who cannot communicate in English (read, write, speak)
  • Diagnosed less than 1 year diabetes
  • Transient form of Diabetes (such as medication induced diabetes)
  • Exclude type 2 Diabetes and CFRD (cystic fibrosis related diabetes)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

Study Officials

  • Vanita Pais, BSc,CDE

    Sick Kids Hospital

    PRINCIPAL INVESTIGATOR
  • Christabelle Almeida, MSc,CDE

    Sick Kids Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Registered Dietitian

Study Record Dates

First Submitted

March 9, 2018

First Posted

November 21, 2019

Study Start

September 18, 2019

Primary Completion

January 30, 2020

Study Completion

January 30, 2020

Last Updated

July 8, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations