Diabetes MellitusGETIT-ParentNCT05445284
Group Education Trial to Improve Transition for Parents of Adolescents With T1D
A study testing Group education sessions for parents plus usual diabetes care and Usual diabetes care in people with Diabetes Mellitus and Diabetes Mellitus, Type 1, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
The investigators will study if group education for parents of adolescents with type 1 diabetes (T1D) will improve the transition from adolescence to adulthood. The investigators aim to conduct a pilot randomized controlled trial (RCT) of parent group education sessions to assess the feasibility and refine the… Read more about this study
- Who is it for?
- Ages 14 to 16 years
- Conditions the study is for
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders
- What is being tested?
- Group education sessions for parents plus usual diabetes care and Usual diabetes care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- 10 Oct 2023to 16 Dec 2025
- Phase
- Interventional
- 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 14 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parents and their adolescents, ages 14-16 years, with a diagnosis of T1D, of at least 6-months. Parent is defined as mother, father, or primary caregiver.
- Receiving diabetes care at a university teaching hospital-based pediatric diabetes clinic in Montreal: Montreal Children's Hospital (MCH)
- Participants must be fluent in English or French
Who cannot join
- Severe neurocognitive disabilities that may preclude parent's ability to participate in a group session
- Parents of adolescents participating in the Group Education Trial to Improve Transition in Type 1 Diabetes (GET-IT-T1D) for adolescents
Trial locations and contacts
1 site in 1 country.
Canada1 site
Montreal Children's Hospital - McGill University Health Centre (MUHC)
Montreal, Quebec, H4A 3J1
About this study
Official title: Group Education Trial to Improve Transition for Parents of Adolescents With Type 1 Diabetes: A Pilot Randomized Controlled, Superiority Trial (GET-IT For Parents)
The investigators will study if group education for parents of adolescents with type 1 diabetes (T1D) will improve the transition from adolescence to adulthood. The investigators aim to conduct a pilot randomized controlled trial (RCT) of parent group education sessions to assess the feasibility and refine the intervention to inform a full-scale multicenter RCT. The aims of the pilot are to estimate: 1. Recruitment rate, 2. Adherence rate, 3. Response rate, and 4. Retention rate. The aims for the future full-scale multicenter RCT are to assess the effect of parent group education sessions integrated into pediatric care, compared with usual care on self-management, hemoglobin A1c (HbA1c), adverse outcomes and validated measures during the transition from adolescence to adulthood. The investigators will conduct a parallel group, blinded (outcome assessors, data analysts), superiority pilot RCT of parents and their adolescents with T1D (14-16 years of age) followed at a university teaching hospital-based pediatric diabetes clinic in Montreal. Interventions will occur over 12-months. Follow-up will be to 18 months from enrollment.
Read the detailed description
Rationale. Adolescence is a challenging life stage that is complicated for those with type 1 diabetes (T1D) as they learn to take responsibility for their health. Parents face uncertainty of what constitutes appropriate involvement and express distress around the health consequences of transferring responsibility to their adolescent. We know little about how to provide transition care services to parents as they attempt to support their adolescents during the transition to adulthood. We are currently conducting a multicenter randomized controlled trial (RCT) evaluating patient-driven group education for adolescents with T1D. Parents have expressed a need for education on how to transition responsibility of diabetes care from parent to adolescent. The investigators propose to study if group education for parents of adolescents with T1D will improve the transition from adolescence to adulthood. The investigators will conduct a pilot RCT of parent group education sessions to assess the feasibility and refine the intervention for a full-scale multicenter RCT.
Aims. The aims of the pilot are to estimate: 1. Recruitment rate, 2. Adherence rate, 3. Response rate, and 4. Retention rate. Through semi-structured interviews with parents, we also aim to identify aspects of the intervention that require refinement for the future full-scale multicenter RCT (e.g. session content and format). To assess feasibility success, we propose the following criteria:1. Recruitment rate: At least 50% of approached parents/adolescents will agree to randomization; 2. Adherence rate: At least 80% of parents attend ≥3 group education sessions; 3. Response rate: At least 80% of parents and adolescents will complete all validated questionnaires; 4. Retention rate: At least 70% of parents and adolescents will complete the trial. The aims for the future full-scale multicenter RCT are to determine the impact of parent group education sessions, compared with usual care on self-management, HbA1c, number of T1D-related emergency department visits and hospitalizations, diabetes distress, family conflict, diabetes resilience and diabetes responsibility.
Methods. The investigators will conduct a parallel group, blinded (outcome assessors, data analysts), superiority pilot RCT of parents and their adolescents with T1D (14-16 years of age) followed at a university teaching hospital-based pediatric diabetes clinic in Montreal. Dyads of adolescents and one parent will be recruited over 12 months. Interventions will occur over 12-months. Follow-up will be to 18 months from enrollment. Allocation will be concealed with a 1:1 intervention to control ratio. Visits in the active arm will consist of a parent group education session plus usual diabetes care every 3 months. The parent group education session, facilitated by a diabetes social worker, will consist of a parent-driven, in-person/virtual discussion on topics relevant to adolescence and transition care. Control arm participants will have usual care with their diabetes care provider every 3 months. Pilot RCT results will inform modification of trial execution related to feasibility and intervention for full-scale multicenter RCT. Main outcome measures are descriptions of study feasibility parameters. Health-related outcomes as well as parent and adolescent reported outcomes, using validated self-administered questionnaires will also be collected at baseline, 6, 12 and 18 months. Parents will be interviewed at baseline and 18 months to explore parents' experiences with and perceptions of the accessibility, acceptance, and usefulness of parent group education content and format, using qualitative descriptive methodology. Analysis will be descriptive and baseline data will be summarized, separately for those in the active and control arms.
- Conditions
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Metabolic Disease, Endocrine System Diseases, Autoimmune Diseases
- Being tested
- Group education sessions for parents plus usual diabetes care, Usual diabetes care
- Keywords
- Transition care, Pediatric, Adolescent, Parent, Education, Self-management, Hemaglobin A1c, Feasibility, Pilot randomized controlled trial
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Autoimmune Diseases, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group education sessions for parents plus usual diabetes careBehavioural
≥3 in person/virtual group education sessions for parents in addition to usual diabetes care, every 3 months for 12 months
Usual diabetes careOther
Usual diabetes care, every 3-month for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Group education sessions for parents plus usual diabetes care | Experimental | ≥3 in-person/virtual one-hour group education sessions for parents plus usual diabetes care, every 3 months for 12 months and ≥3 "check-in" virtual 15-20 minute sessions in-between the group sessions. Each group session (3-8 parents per group) will be facilitated by a diabetes social worker and will consist of parent-driven discussions on topics relevant to adolescence and transition care. Each one-hour session will commence with an ice-breaker activity and then move to a parent-driven, facilitator-mediated discussion. The group session content will be guided by the needs of the participants; however, the facilitator will actively promote discussion on adolescent- and transition-related topics. The group discussion will end with participants setting goals for their next session. Receives: Behavioral: Group education sessions for parents plus usual diabetes care |
| Usual diabetes care | Other | Usual diabetes care, every 3 months for 12 months, which consists of visits with their diabetes care physician. In addition, as per usual care, individual sessions and meetings related to transition care with the diabetes social worker will be provided to parents, as needed. Receives: Other: Usual diabetes care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment feasibility
Recruitment rate. Proportion of all parents/adolescents approached agreeing to randomization. Feasibility success criteria: at least 50% of approached parents/adolescents agree to participate
Measured: 12 months
Adherence feasibility
Adherence rate. Proportion of randomized parents attending ≥3 group education sessions. Feasibility success criteria: at least 80% of parents attend at least 3 one-hour group education/support sessions
Measured: 12 months
Response feasibility
Response rate. Proportion of parents and adolescents completing all validated questionnaires. Feasibility success criteria: at least 80% parents/adolescents complete all questionnaires
Measured: 18 months
Retention feasibility
Retention rate. Proportion of parents/adolescents completing the 18-month outcome measures. Feasibility success criteria: at least 70% of parents/adolescents complete the trial
Measured: 18 months
Secondary outcomes (12)
Parent group education session accessibility, acceptance, usefulness
Parent interviews to explore parents' experiences with and perceptions of the accessibility, acceptance, and usefulness of the parent group education content and format, using qualitative descriptive methodology
Measured: 0, 18 months
Self-Management
Self-Care Inventory-Revised Questionnaire assesses parent and adolescent self-management. The scores range from 1 to 5. Items scores are averaged to compute the score. A higher score represents a better outcome.
Measured: 0, 6, 12, 18 months
Diabetes Distress - Adolescent
Problem Areas in Diabetes Scale-Teen (PAID-T) assesses adolescent diabetes distress. The scores range from 14 to 84. A total distress score is computed by summing responses. Higher scores indicate youth perception of feeling more burdened related to T1D.
Measured: 0, 6, 12, 18 months
Diabetes Distress - Parent
Problem Areas in Diabetes Scale-Parent (PAID-P) assesses parent diabetes distress. The scores range from 15 to 90. A total distress score is computed by summing responses. Higher scores indicate higher levels of distress and burden.
Measured: 0, 6, 12, 18 months
Family Conflict
Diabetes Family Conflict Scale assesses parent and adolescent family conflict. Total scores range from 19 to 57. A total score is calculated by summing all the item scores. Higher scores reflect greater family conflict.
Measured: 0, 6, 12, 18 months
Diabetes Resilience - Adolescent
DSTAR-youth assesses adolescent diabetes resilience. Total scores range from 12 to 60. A total score is calculated by summing all the item scores. Higher scores reflect greater diabetes resilience.
Measured: 0, 6, 12, 18 months
Diabetes Resilience - Parent
Diabetes-Specific Self-Compassion Scale assesses parent diabetes resilience. The score ranges from 1 to 5. A total score is calculated by reverse-scoring the 11 negatively-worded items and taking the mean of all items. Higher scores indicate greater diabetes-specific self compassion.
Measured: 0, 6, 12, 18 months
Responsibility (DFRQ)
Diabetes Family Responsibility Questionnaire (DFRQ) assesses parent and adolescent responsibility (tasks in the family that contribute to the adolescent's diabetes management). Responsibilities are reflected in three domains: general health maintenance, regimen tasks, and social presentation. A total mean score across items is calculated. The score ranges from 1 to 3. Higher scores reflect that the adolescent is taking or initiating responsibility almost all the time.
Measured: 0, 6, 12, 18 months
Responsibility (RCBRS)
Readiness to Change the Balance of Responsibility Scale (RCBRS) assesses parent and adolescent responsibility. The score ranges from 1 to 5. A mean score of the 12 items (parent) and the seven items (youth) is calculated. Higher scores represent more readiness to change.
Measured: 0, 6, 12, 18 months
Hemaglobin A1c (HbA1c)
HbA1c is measured at each pediatric diabetes care visit every 3 months as part of the standard of diabetes care and is measured with a capillary blood sample using point of care testing (DCA 2000).HbA1c will be identified from medical record chart.
Measured: 0, 6, 12, 18 months
Diabetes-related hospitalizations
Any diabetes-related hospitalizations in the past 12 months, expressed as number of hospitalizations per person-years (P-Y) at risk will be derived from medical record chart.
Measured: 0, 12 months
Diabetes-related emergency department visits
Any diabetes-related emergency-department visits in the past 12 months, expressed as number of emergency department visits per person-years (P-Y) at risk will be derived from medical record chart
Measured: 0, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start10 Oct 2023
- Primary completion16 Dec 2025
- Study completion16 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Active arm: Participants randomized to the active arm will be asked to attend ≥ 3 group education sessions for parents of adolescents with T1D, in addition to their usual diabetes clinic visits every 3 months, over the 12-month intervention period. Group education sessions will coincide with regularly scheduled clinic visits. Control arm: Participants randomized to usual care will attend their usual 3-month interval diabetes clinic visits, over the 12-month intervention period, which consists of visits with their diabetes care physician.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Diabetes Canada
- Responsible party
- Principal investigator, Meranda Nakhla, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Meranda Nakhla, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05445284
- Sponsor's protocol ID
- 2022-8592
- Acronym
- GETIT-Parent
- Status last verified
- Oct 2026
- First submitted
- 27 Jun 2022
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data supporting the results reported in the published research articles, after de-identification will be available only for the full-scale RCT.
Publications
Ladd JM, Reeves-Latour J, Dasgupta K, Bell LE, Anjachak N, Nakhla M. Toward a better understanding of transition from paediatric to adult care in type 1 diabetes: A qualitative study of adolescents. Diabet Med. 2022 May;39(5):e14781. doi: 10.1111/dme.14781. Epub 2022 Jan 7.
PubMed 34967058Alwadiy F, Mok E, Dasgupta K, Rahme E, Frei J, Nakhla M. Association of Self-Efficacy, Transition Readiness and Diabetes Distress With Glycemic Control in Adolescents With Type 1 Diabetes Preparing to Transition to Adult Care. Can J Diabetes. 2021 Jul;45(5):490-495. doi: 10.1016/j.jcjd.2021.05.006. Epub 2021 May 19.
PubMed 34176613Robinson ME, Simard M, Larocque I, Shah J, Rahme E, Nakhla M. Psychiatric disorders in emerging adults with diabetes transitioning to adult care: A retrospective cohort study. Diabet Med. 2021 Jun;38(6):e14541. doi: 10.1111/dme.14541. Epub 2021 Feb 19.
PubMed 33576092Mok E, Henderson M, Dasgupta K, Rahme E, Hajizadeh M, Bell L, Prevost M, Frei J, Nakhla M. Group education for adolescents with type 1 diabetes during transition from paediatric to adult care: study protocol for a multisite, randomised controlled, superiority trial (GET-IT-T1D). BMJ Open. 2019 Nov 11;9(11):e033806. doi: 10.1136/bmjopen-2019-033806.
PubMed 31719096Michaud S, Dasgupta K, Bell L, Yale JF, Anjachak N, Wafa S, Nakhla M. Adult care providers' perspectives on the transition to adult care for emerging adults with Type 1 diabetes: a cross-sectional survey. Diabet Med. 2018 Jul;35(7):846-854. doi: 10.1111/dme.13627. Epub 2018 May 2.
PubMed 29577410Nakhla M, Bell LE, Wafa S, Dasgupta K. Improving the transition from pediatric to adult diabetes care: the pediatric care provider's perspective in Quebec, Canada. BMJ Open Diabetes Res Care. 2017 Jun 30;5(1):e000390. doi: 10.1136/bmjdrc-2017-000390. eCollection 2017.
PubMed 28761657Wafa S, Nakhla M. Improving the Transition from Pediatric to Adult Diabetes Healthcare: A Literature Review. Can J Diabetes. 2015 Dec;39(6):520-8. doi: 10.1016/j.jcjd.2015.08.003. Epub 2015 Oct 20.
PubMed 26498219Nakhla M, Daneman D, To T, Paradis G, Guttmann A. Transition to adult care for youths with diabetes mellitus: findings from a Universal Health Care System. Pediatrics. 2009 Dec;124(6):e1134-41. doi: 10.1542/peds.2009-0041. Epub 2009 Nov 23.
PubMed 19933731Nakhla M, Daneman D, Frank M, Guttmann A. Translating transition: a critical review of the diabetes literature. J Pediatr Endocrinol Metab. 2008 Jun;21(6):507-16.
PubMed 18717235Tapp K, Mok E, Davis D, Guerin-Marion S, Frei J, Gibbon M, Henderson M, Miljanovski M, Da Costa D, Shulman R, Nakhla M, Kichler J. Perspectives of parents/caregivers prior to a pilot intervention trial to improve transition to adult care for adolescents with type 1 diabetes: A qualitative study. BMJ Open. 2025 Dec 29;15(12):e108079. doi: 10.1136/bmjopen-2025-108079.
PubMed 41469044
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Education Trial to Improve Transition for Parents of Adolescents With Type 1 Diabetes: A Pilot Randomized Controlled, Superiority Trial (GET-IT For Parents)
- ClinicalTrials.gov ID
- NCT05445284
- Acronym / sponsor ID
- GETIT-Parent / 2022-8592
- Conditions
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Metabolic Disease, Endocrine System Diseases, Autoimmune Diseases
- Keywords
- Transition care, Pediatric, Adolescent, Parent, Education, Self-management, Hemaglobin A1c, Feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Diabetes Canada
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 16 Dec 2025 (actual)
- Study completion
- 16 Dec 2025 (actual)
- First posted
- 6 Jul 2022 (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.
The investigators will study if group education for parents of adolescents with type 1 diabetes (T1D) will improve the transition from adolescence to adulthood. The investigators aim to conduct a pilot randomized controlled trial (RCT) of parent group education sessions to assess the feasibility and refine the intervention to inform a full-scale multicenter RCT. The aims of the pilot are to estimate: 1. Recruitment rate, 2. Adherence rate, 3. Response rate, and 4. Retention rate. The aims for the future full-scale multicenter RCT are to assess the effect of parent group education sessions integrated into pediatric care, compared with usual care on self-management, hemoglobin A1c (HbA1c), adverse outcomes and validated measures during the transition from adolescence to adulthood. The investigators will conduct a parallel group, blinded (outcome assessors, data analysts), superiority pilot RCT of parents and their adolescents with T1D (14-16 years of age) followed at a university teaching hospital-based pediatric diabetes clinic in Montreal. Interventions will occur over 12-months. Follow-up will be to 18 months from enrollment.
Detailed description
Rationale. Adolescence is a challenging life stage that is complicated for those with type 1 diabetes (T1D) as they learn to take responsibility for their health. Parents face uncertainty of what constitutes appropriate involvement and express distress around the health consequences of transferring responsibility to their adolescent. We know little about how to provide transition care services to parents as they attempt to support their adolescents during the transition to adulthood. We are currently conducting a multicenter randomized controlled trial (RCT) evaluating patient-driven group education for adolescents with T1D. Parents have expressed a need for education on how to transition responsibility of diabetes care from parent to adolescent. The investigators propose to study if group education for parents of adolescents with T1D will improve the transition from adolescence to adulthood. The investigators will conduct a pilot RCT of parent group education sessions to assess the feasibility and refine the intervention for a full-scale multicenter RCT.
Aims. The aims of the pilot are to estimate: 1. Recruitment rate, 2. Adherence rate, 3. Response rate, and 4. Retention rate. Through semi-structured interviews with parents, we also aim to identify aspects of the intervention that require refinement for the future full-scale multicenter RCT (e.g. session content and format). To assess feasibility success, we propose the following criteria:1. Recruitment rate: At least 50% of approached parents/adolescents will agree to randomization; 2. Adherence rate: At least 80% of parents attend ≥3 group education sessions; 3. Response rate: At least 80% of parents and adolescents will complete all validated questionnaires; 4. Retention rate: At least 70% of parents and adolescents will complete the trial. The aims for the future full-scale multicenter RCT are to determine the impact of parent group education sessions, compared with usual care on self-management, HbA1c, number of T1D-related emergency department visits and hospitalizations, diabetes distress, family conflict, diabetes resilience and diabetes responsibility.
Methods. The investigators will conduct a parallel group, blinded (outcome assessors, data analysts), superiority pilot RCT of parents and their adolescents with T1D (14-16 years of age) followed at a university teaching hospital-based pediatric diabetes clinic in Montreal. Dyads of adolescents and one parent will be recruited over 12 months. Interventions will occur over 12-months. Follow-up will be to 18 months from enrollment. Allocation will be concealed with a 1:1 intervention to control ratio. Visits in the active arm will consist of a parent group education session plus usual diabetes care every 3 months. The parent group education session, facilitated by a diabetes social worker, will consist of a parent-driven, in-person/virtual discussion on topics relevant to adolescence and transition care. Control arm participants will have usual care with their diabetes care provider every 3 months. Pilot RCT results will inform modification of trial execution related to feasibility and intervention for full-scale multicenter RCT. Main outcome measures are descriptions of study feasibility parameters. Health-related outcomes as well as parent and adolescent reported outcomes, using validated self-administered questionnaires will also be collected at baseline, 6, 12 and 18 months. Parents will be interviewed at baseline and 18 months to explore parents' experiences with and perceptions of the accessibility, acceptance, and usefulness of parent group education content and format, using qualitative descriptive methodology. Analysis will be descriptive and baseline data will be summarized, separately for those in the active and control arms.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Active arm: Participants randomized to the active arm will be asked to attend ≥ 3 group education sessions for parents of adolescents with T1D, in addition to their usual diabetes clinic visits every 3 months, over the 12-month intervention period. Group education sessions will coincide with regularly scheduled clinic visits. Control arm: Participants randomized to usual care will attend their usual 3-month interval diabetes clinic visits, over the 12-month intervention period, which consists of visits with their diabetes care physician.
| Arm | Type | Receives |
|---|---|---|
| Group education sessions for parents plus usual diabetes care | Experimental | Behavioral: Group education sessions for parents plus usual diabetes care≥3 in-person/virtual one-hour group education sessions for parents plus usual diabetes care, every 3 months for 12 months and ≥3 "check-in" virtual 15-20 minute sessions in-between the group sessions. Each group session (3-8 parents per group) will be facilitated by a diabetes social worker and will consist of parent-driven discussions on topics relevant to adolescence and transition care. Each one-hour session will commence with an ice-breaker activity and then move to a parent-driven, facilitator-mediated discussion. The group session content will be guided by the needs of the participants; however, the facilitator will actively promote discussion on adolescent- and transition-related topics. The group discussion will end with participants setting goals for their next session. |
| Usual diabetes care | Other | Other: Usual diabetes careUsual diabetes care, every 3 months for 12 months, which consists of visits with their diabetes care physician. In addition, as per usual care, individual sessions and meetings related to transition care with the diabetes social worker will be provided to parents, as needed. |
Who may qualify
- Ages
- 14 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Parents and their adolescents, ages 14-16 years, with a diagnosis of T1D, of at least 6-months. Parent is defined as mother, father, or primary caregiver.
- Receiving diabetes care at a university teaching hospital-based pediatric diabetes clinic in Montreal: Montreal Children's Hospital (MCH)
- Participants must be fluent in English or French
Key exclusion criteria (2 listed)
- Severe neurocognitive disabilities that may preclude parent's ability to participate in a group session
- Parents of adolescents participating in the Group Education Trial to Improve Transition in Type 1 Diabetes (GET-IT-T1D) for adolescents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group education sessions for parents plus usual diabetes care≥3 in person/virtual group education sessions for parents in addition to usual diabetes care, every 3 months for 12 months | Behavioural | Group education sessions for parents plus usual diabetes care |
| Usual diabetes careUsual diabetes care, every 3-month for 12 months | Other | Usual diabetes care |
Primary outcome
Recruitment feasibility
Time frame: 12 months
Recruitment rate. Proportion of all parents/adolescents approached agreeing to randomization. Feasibility success criteria: at least 50% of approached parents/adolescents agree to participate
Adherence feasibility
Time frame: 12 months
Adherence rate. Proportion of randomized parents attending ≥3 group education sessions. Feasibility success criteria: at least 80% of parents attend at least 3 one-hour group education/support sessions
Response feasibility
Time frame: 18 months
Response rate. Proportion of parents and adolescents completing all validated questionnaires. Feasibility success criteria: at least 80% parents/adolescents complete all questionnaires
Retention feasibility
Time frame: 18 months
Retention rate. Proportion of parents/adolescents completing the 18-month outcome measures. Feasibility success criteria: at least 70% of parents/adolescents complete the trial
12 secondary outcomes
Parent group education session accessibility, acceptance, usefulness
Time frame: 0, 18 months
Self-Management
Time frame: 0, 6, 12, 18 months
Diabetes Distress - Adolescent
Time frame: 0, 6, 12, 18 months
Diabetes Distress - Parent
Time frame: 0, 6, 12, 18 months
Family Conflict
Time frame: 0, 6, 12, 18 months
Diabetes Resilience - Adolescent
Time frame: 0, 6, 12, 18 months
Diabetes Resilience - Parent
Time frame: 0, 6, 12, 18 months
Responsibility (DFRQ)
Time frame: 0, 6, 12, 18 months
Responsibility (RCBRS)
Time frame: 0, 6, 12, 18 months
Hemaglobin A1c (HbA1c)
Time frame: 0, 6, 12, 18 months
Diabetes-related hospitalizations
Time frame: 0, 12 months
Diabetes-related emergency department visits
Time frame: 0, 12 months
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 7 Oct 2026.
- Background: PubMed 34967058Ladd JM, Reeves-Latour J, Dasgupta K, Bell LE, Anjachak N, Nakhla M. Toward a better understanding of transition from paediatric to adult care in type 1 diabetes: A qualitative study of adolescents. Diabet Med. 2022 May;39(5):e14781. doi: 10.1111/dme.14781. Epub 2022 Jan 7.
- Background: PubMed 34176613Alwadiy F, Mok E, Dasgupta K, Rahme E, Frei J, Nakhla M. Association of Self-Efficacy, Transition Readiness and Diabetes Distress With Glycemic Control in Adolescents With Type 1 Diabetes Preparing to Transition to Adult Care. Can J Diabetes. 2021 Jul;45(5):490-495. doi: 10.1016/j.jcjd.2021.05.006. Epub 2021 May 19.
- Background: PubMed 33576092Robinson ME, Simard M, Larocque I, Shah J, Rahme E, Nakhla M. Psychiatric disorders in emerging adults with diabetes transitioning to adult care: A retrospective cohort study. Diabet Med. 2021 Jun;38(6):e14541. doi: 10.1111/dme.14541. Epub 2021 Feb 19.
- Background: PubMed 31719096Mok E, Henderson M, Dasgupta K, Rahme E, Hajizadeh M, Bell L, Prevost M, Frei J, Nakhla M. Group education for adolescents with type 1 diabetes during transition from paediatric to adult care: study protocol for a multisite, randomised controlled, superiority trial (GET-IT-T1D). BMJ Open. 2019 Nov 11;9(11):e033806. doi: 10.1136/bmjopen-2019-033806.
- Background: PubMed 29577410Michaud S, Dasgupta K, Bell L, Yale JF, Anjachak N, Wafa S, Nakhla M. Adult care providers' perspectives on the transition to adult care for emerging adults with Type 1 diabetes: a cross-sectional survey. Diabet Med. 2018 Jul;35(7):846-854. doi: 10.1111/dme.13627. Epub 2018 May 2.
- Background: PubMed 28761657Nakhla M, Bell LE, Wafa S, Dasgupta K. Improving the transition from pediatric to adult diabetes care: the pediatric care provider's perspective in Quebec, Canada. BMJ Open Diabetes Res Care. 2017 Jun 30;5(1):e000390. doi: 10.1136/bmjdrc-2017-000390. eCollection 2017.
- Background: PubMed 26498219Wafa S, Nakhla M. Improving the Transition from Pediatric to Adult Diabetes Healthcare: A Literature Review. Can J Diabetes. 2015 Dec;39(6):520-8. doi: 10.1016/j.jcjd.2015.08.003. Epub 2015 Oct 20.
- Background: PubMed 19933731Nakhla M, Daneman D, To T, Paradis G, Guttmann A. Transition to adult care for youths with diabetes mellitus: findings from a Universal Health Care System. Pediatrics. 2009 Dec;124(6):e1134-41. doi: 10.1542/peds.2009-0041. Epub 2009 Nov 23.
- Background: PubMed 18717235Nakhla M, Daneman D, Frank M, Guttmann A. Translating transition: a critical review of the diabetes literature. J Pediatr Endocrinol Metab. 2008 Jun;21(6):507-16.
- Derived from this study: PubMed 41469044Tapp K, Mok E, Davis D, Guerin-Marion S, Frei J, Gibbon M, Henderson M, Miljanovski M, Da Costa D, Shulman R, Nakhla M, Kichler J. Perspectives of parents/caregivers prior to a pilot intervention trial to improve transition to adult care for adolescents with type 1 diabetes: A qualitative study. BMJ Open. 2025 Dec 29;15(12):e108079. doi: 10.1136/bmjopen-2025-108079.
- Individual participant dataSharing planned: No. Individual participant data supporting the results reported in the published research articles, after de-identification will be available only for the full-scale RCT.
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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.
Meranda Nakhla, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group education sessions for parents plus usual diabetes care and Usual diabetes care in people with Diabetes Mellitus and Diabetes Mellitus, Type 1, run by McGill University Health Centre/Research Institute of the McGill University Health Centre 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 3 inclusion and 2 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 7 Oct 2026. 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?
Recruitment feasibility (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05445284, which also lists 10 linked publications.
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 7 Oct 2026.