group education trial to improve transition for parents of adolescents with t1d

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

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 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.

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.

Eligibility criteria:
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

Keywords: transition care pediatric adolescent parent education self-management hemaglobin a1c feasibility pilot randomized controlled trial