Type1diabetesNCT04172077
Self Efficacy Levels, Attachment Style and Resiliency of Youth With Type 1 Diabetes
An observational study of Type1diabetes, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Type1diabetes
- How many people
- 170 participants
- Where
- 1 siteCanada
- Study dates
- 18 Sep 2019to 30 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: T1DM patients aged 12 - 18 yrs from Sick Kids Diabetes Clinic and their primary caregiver.
Who may be able to join
- T1DM patients age 12 - 18 yrs from Sick Kids Diabetes Clinic and a primary caregiver
- T1DM > 1yr and able to communicate in English
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Of Self Efficacy Levels, Resiliency Levels and Attachment Styles of Adolescents With Type 1 Diabetes and Their Caregivers
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.
- Conditions
- Type1diabetes
- Keywords
- Self Efficacy, Resiliency, Attachment style and youth with type 1 diabetes
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 25 minutes
Secondary outcomes (4)
a) Effect of attachment style on self efficacy level in patients.
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'.
Measured: 25 minutes
a) Effect of attachment style on self efficacy level in parents.
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'.
Measured: 25 minutes
b)Compare diabetes management self-efficacy and attachment style in patients.
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.
Measured: 25 minutes
b)Compare diabetes management self-efficacy and attachment style in parents
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.
Measured: 25 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start18 Sep 2019
- Primary completion30 Jan 2020
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vanita Pais, The Hospital for Sick Children
- Investigators
- Vanita Pais, BSc,CDE, Principal investigator, Sick Kids HospitalChristabelle Almeida, MSc,CDE, Study director, Sick Kids Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172077
- Sponsor's protocol ID
- 1000059604
- Status last verified
- Jul 2021
- First submitted
- 9 Mar 2018
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Of Self Efficacy Levels, Resiliency Levels and Attachment Styles of Adolescents With Type 1 Diabetes and Their Caregivers
- ClinicalTrials.gov ID
- NCT04172077
- Acronym / sponsor ID
- 1000059604
- Conditions
- Type1diabetes
- Keywords
- Self Efficacy, Resiliency, Attachment style and youth with type 1 diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 18 Sep 2019 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 21 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- T1DM patients aged 12 - 18 yrs from Sick Kids Diabetes Clinic and their primary caregiver.
Key inclusion criteria (2 listed)
- T1DM patients age 12 - 18 yrs from Sick Kids Diabetes Clinic and a primary caregiver
- T1DM > 1yr and able to communicate in English
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
a) Effect of attachment style on self efficacy level in patients.
Time frame: 25 minutes
a) Effect of attachment style on self efficacy level in parents.
Time frame: 25 minutes
b)Compare diabetes management self-efficacy and attachment style in patients.
Time frame: 25 minutes
b)Compare diabetes management self-efficacy and attachment style in parents
Time frame: 25 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vanita Pais, BSc,CDE principal investigator
Sick Kids Hospital
Christabelle Almeida, MSc,CDE study director
Sick Kids Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type1diabetes, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2021.