Group Education Trial to Improve Transition for Parents of Adolescents With T1D

Study Overview
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Brief Summary
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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
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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.

Official Title
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Group Education Trial to Improve Transition for Parents of Adolescents With Type 1 Diabetes: A Pilot Randomized Controlled, Superiority Trial (GET-IT For Parents)

Conditions
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Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Metabolic Disease, Endocrine System Diseases, Autoimmune Diseases, Immune System Diseases

Intervention / Treatment
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* Behavioral: Group education sessions for parents plus usual diabetes care
* Other: Usual diabetes care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group education sessions for parents plus usual diabetes care<br>≥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. | Behavioral: Group education sessions for parents plus usual diabetes care<br>* ≥3 in person/virtual group education sessions for parents in addition to usual diabetes care, every 3 months for 12 months<br>|
| Other: Usual diabetes care<br>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. | Other: Usual diabetes care<br>* Usual diabetes care, every 3-month for 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 0, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transition care, Pediatric, Adolescent, Parent, Education, Self-management, Hemaglobin A1c, Feasibility, Pilot randomized controlled trial