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IRCT20260929071238N1 IRCT 2026-10-05 Islamic Azad University Effect of family empowerment on self-management in adolescents with type 1 diabetes The Effect of a Family-Centered Empowerment Model on Self-Management in Adolescents with Type 1 Diabetes 2026-10-23 anticipated 90 Recruiting https://irct.ir/trial/93782 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: The study is a randomized controlled trial (RCT), parallel-group, open-label design. Participants are allocated to either the intervention or control group using block randomization (block size of 4). Allocation concealment is ensured using Sequentially Numbered, Opaque, Sealed Envelopes (SNOSE), Randomization description: Eligible adolescents, following screening based on inclusion and exclusion criteria, were allocated into intervention (family-centered empowerment model) and control groups in a 1:1 ratio using permuted block randomization with a block size of 4. The random allocation sequence was generated using a table of random numbers. To ensure allocation concealment, sequentially numbered, opaque, sealed envelopes (SNOSE) were utilized; each participant’s envelope was opened sequentially only after obtaining written informed consent and confirming enrollment by an individual independent of the intervention team. N/A Type 1 Diabetes Mellitus. Intervention 1: Intervention group: Participants in the intervention group along with one of their parents will participate in an educational program based on the Family-Centered Empowerment Model (FCEM). The program consists of six 90-minute educational sessions conducted bi-weekly over 3 months (in-person and in small groups) at the hospital diabetes clinic. The intervention follows four steps: 1) Enhancing perceived threat (knowledge about diabetes nature, complications, and consequences of poor control), 2) Improving self-efficacy through problem-solving and practical skills (hands-on blood glucose monitoring, insulin injection technique, dietary and physical activity management, and handling emergencies), 3) Increasing self-esteem through educational participation (reinforcing the adolescent’s role as an educational ambassador to share learning with family members and peer discussions), and 4) Formative and summative evaluation (assessing knowledge retention, addressing questions, and treatment adherence). An educational booklet will also be provided at the end of the intervention. Intervention 2: Control group: Participants in the control group will only receive routine care and standard education provided at the hospital diabetes clinic (including periodic physician visits and standard advice from healthcare providers), with no structured empowerment program. To comply with research ethics, an educational summary booklet of the empowerment model will be provided to the control group participants and their families after completion of the study and post-test assessments. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to the necessity of maintaining strict confidentiality regarding the personal and identity-related information of the participants (children and adolescents), in accordance with biomedical ethics codes, and given that written informed consent was not obtained from parents or participants for the public disclosure of raw data in open-access databases, there is no plan to share the Individual Participant Data (IPD). However, the aggregated results and statistical analyses of this study will be published in the form of a thesis and scientific manuscripts.
public Faezeh Farajpour
Rahimian Hospital, Azadi 30th St, Moallem Blvd, Alvand
Alvand Iran (Islamic Republic of) 3431855595 +98 28 3222 9701 Rahimian.hospital@qums.ac.ir Islamic Azad University scientific Nooshin Abbasi Abyaneh
Faculty of Nursing and Midwifery, Educational Block 1, 5th Floor, Science and Research Branch, Islamic Azad University, Shohadaye Hesarak Blvd, Daneshgah Sq, End of North Sattari Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1477893855 +98 21 2200 4355 nooshin.abbasi@yahoo.com Islamic Azad University Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Age between 12 and 18 years at the time of entry into the study. Definitive diagnosis of type 1 diabetes mellitus by a pediatric endocrinologist based on standard diagnostic criteria. At least 6 months of documented history of type 1 diabetes to ensure familiarity of the adolescent and family with disease management principles. Receiving insulin therapy as the primary treatment regimen. Regular follow-up at the diabetes clinic or pediatric endocrinology center during the study period. Having at least one parent or primary caregiver (mother, father, or legal guardian) willing and able to participate in the family-centered empowerment program. Absence of acute or chronic comorbid conditions that could affect diabetes self-management ability, participation in educational sessions, or outcome evaluations. Ability of both the adolescent and parent/caregiver to communicate effectively and comprehend the educational content provided in the intervention sessions. Ability to read, write, and comprehend educational materials and complete the study questionnaires. No participation in similar structured diabetes education, self-management promotion programs, or family-centered empowerment interventions within the past 6 months. Providing written informed consent by parents or legal guardians along with written informed assent from the adolescent prior to study enrollment. 12 years 18 years Both Occurrence of acute medical complications: Development of acute diabetes complications (such as severe diabetic ketoacidosis or hypoglycemia requiring emergency intervention) or any other acute underlying illness leading to prolonged hospitalization that prevents active participation in the study. Non-adherence to the intervention protocol: Absence from more than one-third (or more than two sessions) of the educational intervention sessions or failure to perform the activities and follow-ups specified in the empowerment model. Voluntary withdrawal: The desire of the parent or adolescent to withdraw from the study at any stage of the research process. Major changes in the treatment regimen: Implementation of significant and unusual changes in the adolescent’s medication/treatment protocol outside of the routine clinic plan during the intervention period. Migration or loss to follow-up: Change of residence, lack of response to follow-ups, or inability to establish communication for post-test evaluations. E10 Insulin-dependent diabetes mellitus Behavior N/A Intervention group: Participants in the intervention group along with one of their parents will participate in an educational program based on the Family-Centered Empowerment Model (FCEM). The program consists of six 90-minute educational sessions conducted bi-weekly over 3 months (in-person and in small groups) at the hospital diabetes clinic. The intervention follows four steps: 1) Enhancing perceived threat (knowledge about diabetes nature, complications, and consequences of poor control), 2) Improving self-efficacy through problem-solving and practical skills (hands-on blood glucose monitoring, insulin injection technique, dietary and physical activity management, and handling emergencies), 3) Increasing self-esteem through educational participation (reinforcing the adolescent’s role as an educational ambassador to share learning with family members and peer discussions), and 4) Formative and summative evaluation (assessing knowledge retention, addressing questions, and treatment adherence). An educational booklet will also be provided at the end of the intervention. Control group: Participants in the control group will only receive routine care and standard education provided at the hospital diabetes clinic (including periodic physician visits and standard advice from healthcare providers), with no structured empowerment program. To comply with research ethics, an educational summary booklet of the empowerment model will be provided to the control group participants and their families after completion of the study and post-test assessments. Diabetes self-management score measured by the standardized Diabetes Self-Management Questionnaire (comprising 27 items across 4 domains: glucose monitoring, diet, physical activity, and healthcare contact, scored on a 5-point Likert scale with total score ranging from 27 to 135). Timepoint: At baseline (prior to intervention) and 3 months after completion of the intervention. Method of measurement: Self-reporting completion of the standardized Diabetes Self-Management Questionnaire by the adolescent. Islamic Azad University Approved 2026-04-20 Ethics Committee of Tehran Islamic Azad University of Medical Sciences Faculty of Nursing and Midwifery, Educational Block 1, Science and Research Branch, Islamic Azad University, Shohada-ye Hesarak Blvd, Daneshgah Sq, End of Shahid Sattari Expressway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)