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Self Efficacy Levels, Attachment Style and Resiliency of Youth With Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT04172077
Recruitment Status : Recruiting
First Posted : November 21, 2019
Last Update Posted : November 21, 2019
Sponsor:
Information provided by (Responsible Party):
Vanita Pais, The Hospital for Sick Children

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.

Condition or disease
Type1diabetes

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Study Type : Observational
Estimated Enrollment : 170 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Association Of Self Efficacy Levels, Resiliency Levels and Attachment Styles of Adolescents With Type 1 Diabetes and Their Caregivers
Actual Study Start Date : September 18, 2019
Estimated Primary Completion Date : January 30, 2020
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1




Primary Outcome Measures :
  1. Examine the effects of patients' attachment styles (secure, mixed and fearful) on their type one diabetes management represented by A1C level [ Time Frame: 25 minutes ]

    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.



Secondary Outcome Measures :
  1. a) Effect of attachment style on self efficacy level in patients. [ Time Frame: 25 minutes ]
    The following tool will be used - Self-Efficacy of Diabetes Self-Management (SEDM): This is a 10-item questionnaire that is used to assess perceived self-efficacy to preform diabetes care behaviours. Respondents are asked to score responses on a 1-10 Likert scale in which '1= not at all sure' to '10= completely sure'.

  2. a) Effect of attachment style on self efficacy level in parents. [ Time Frame: 25 minutes ]
    The following tool will be used - Self-Efficacy of Diabetes Self-Management (SEDM): This is a 10-item questionnaire that is used to assess perceived self-efficacy to preform diabetes care behaviours. Respondents are asked to score responses on a 1-10 Likert scale in which '1= not at all sure' to '10= completely sure'.

  3. b)Compare diabetes management self-efficacy and attachment style in patients. [ Time Frame: 25 minutes ]
    To compare diabetes self-efficacy (SEDM) in patients and their parents, paired t-tests will be calculated. In addition, to compare attachment styles in patients and their parents, McNemar's test will be used. Paired t-tests and McNemar's tests effectively take into account the correlations between parent-adolescent measures from the same family.

  4. b)Compare diabetes management self-efficacy and attachment style in parents [ Time Frame: 25 minutes ]
    To compare diabetes self-efficacy (SEDM) in patients and their parents, paired t-tests will be calculated. In addition, to compare attachment styles in patients and their parents, McNemar's test will be used. Paired t-tests and McNemar's tests effectively take into account the correlations between parent-adolescent measures from the same family.



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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
T1DM patients aged 12 - 18 yrs from Sick Kids Diabetes Clinic and their primary caregiver.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

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): NCT04172077


Contacts
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Contact: Vanita Pais, BSc,CDE 416-813-5745 vanita.pais@sickkids.ca
Contact: Christabelle Almeida, MSc,CDE 416-813-5838 ext 5 christabelle.almeida@sickkids.ca

Locations
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Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G1X8
Contact: Vanita Pais    4168135745    vanita.pais@sickkids.ca   
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Vanita Pais, BSc,CDE Sick Kids Hospital
Study Director: Christabelle Almeida, MSc,CDE Sick Kids Hospital

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Responsible Party: Vanita Pais, Registered Dietitian, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT04172077     History of Changes
Other Study ID Numbers: 1000059604
First Posted: November 21, 2019    Key Record Dates
Last Update Posted: November 21, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vanita Pais, The Hospital for Sick Children:
Self Efficacy
Resiliency
Attachment style and youth with type 1 diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases