Clinical Research Directory

Optimizing Care Transitions in CHD

Adolescents and young adults (AYA) with congenital heart disease (CHD) face psychosocial stresses as they transition to adult care. Parents of AYA with CHD also experience increased caregiver burden and psychosocial stresses. Peer support provided by a person with a similar experience has been found to improve disease self-management and psychosocial health outcomes in pediatric healthcare. However, many AYA with CHD still do not have access to formal social support resources. The aim of this study is to improve pediatric to adult transitions in healthcare by evaluating peer mentorship programs for AYA with CHD and their parents. Established, online mentorship programs, iPeer2Peer(iP2P)/iParent2Parent, will be employed through a pilot feasibility waitlist randomized controlled trial with repeated measures across four sites. Eighty mentees (AYA and parents of AYA) will be recruited and randomized into intervention and control groups. Forty mentees in the intervention group will be matched 1:1 with 30 trained mentors (young adults and parents of AYA). AYA mentees will be matched with young adult mentors and parents of AYA will be matched with other parent mentors. These pairings will connect over 12 weeks through video calls and text messaging to provide peer support to improve self-management and psychosocial health outcomes.

Comprehensive Intervention to Promote Adjustment in Adolescents With Type 1 Diabetes and Their Parents During Transfer of Health Care Responsibility

Introduction: Type 1 diabetes mellitus is a health condition that produces physical and psychosocial alterations in both the person the person with diabetes mellitus and his or her family, that is why interventions should be designed that make a comprehensive approach to the physiological and psychological aspects of adolescents and parents in order to achieve adaptation to a new normality in the framework of this health condition. Objective: To establish the preliminary efficacy of a comprehensive intervention to promote adaptation in adolescents with type 1 diabetes mellitus and their parents during the transfer of health care responsibility in Bogota, Colombia 2023-2025. Materials and methods: we propose to conduct a pilot study that will develop and evaluate a comprehensive intervention to promote adaptation in adolescents with DM1 and their parents. In the qualitative phase, the needs of adolescents with type 1 diabetes mellitus and their parents will be explored through focus groups. In the quantitative phase, the intervention will be designed and its feasibility, acceptability and preliminary efficacy will be evaluated. A content analysis will be performed on the qualitative data and descriptive and inferential statistical tools will be used for the quantitative data, considering the behavior of the data. Expected results: It is expected to evaluate the preliminary efficacy of a comprehensive intervention to promote adaptation in adolescents with diabetes.

Think-Find-Solve Activities for Insulin Self-Management in Type 1 Diabetes

Children with type 1 diabetes require lifelong insulin therapy. However, improper management of insulin therapy may lead to serious, potentially life-threatening complications. The aim of this study is to examine the effect of an activity book developed for insulin therapy on insulin self-management among children with type 1 diabetes and their parents. The study is designed as a cluster randomized controlled experimental trial at the center level, including pre-test, 1- month, and 3-month follow-up measurements. The study will be initiated after obtaining ethical approval and institutional permissions. The sample will consist of children aged 8-12 years with type 1 diabetes and their parents. The study will be conducted in two different hospitals in Istanbul; using cluster randomization, one hospital will be assigned to the intervention group and the other to the control group. Prior to the main study, a pilot study will be conducted with 15 participants in each group, and the sample size will be calculated using G\*Power based on the pilot data. Data will be collected using the "Descriptive Information Form for Children with Diabetes" and the "Insulin Treatment Self-Management Scale (ITSMS) - Child (8-18 years) and Parent Forms." The "Find-Solve-Learn Insulin Self-Management Activity Book" will be applied to the children in the intervention group. The children will be monitored to complete the activity book at least twice a month for three months, and feedback will be obtained from their families regarding the process. The data collection process will include pre-test, 1-month, and 3-month follow-up measurements. The obtained data will be analyzed using appropriate statistical methods.

Effect of Progressive Muscle Relaxation on Parental Anxiety

This randomized controlled trial aims to evaluate the effect of progressive muscle relaxation exercises on anxiety levels among parents who are the primary caregivers of children diagnosed with cancer and receiving inpatient treatment. A total of 112 parents will be randomly assigned to either the intervention or control group. Parents in the intervention group will participate in researcher-led progressive muscle relaxation sessions. Anxiety will be assessed using the State Anxiety Inventory (STAI-I). The study will be conducted at the Pediatric Hematology-Oncology Clinic of Akdeniz University Hospital in Antalya, Türkiye.

The Latino Youth and Family Empowerment Study - III (LYFE-III): Bringing to Scale a Culturally-Adapted and Evidence-Based Intervention for Latino Families

The objective of this study is to harness digital technology to bring to scale a culturally adapted and evidence-based parenting intervention for Latinos (Nuestras Familias: Andando Entre Culturas). The Latino Youth and Family Empowerment - III study (LYFE-III) proposed here will adapt, scale, and evaluate the efficacy of an online version of Nuestras Familias with Latino parents and youth in a randomized controlled trial (RCT). The specific aims are as follows: Aim 1. To adapt the Nuestras Familias intervention to an online format that can be widely accessed by underserved Latino families. This process includes intervention refinement, enhancing efficiency, and manualization of intervention content Aim 2. Conduct a small randomized controlled pilot trial to (a) test the online program's promise while evaluating changes in target mechanisms of action (i.e., parenting practices) and their subsequent effects on youth mental health outcomes; and (b) to evaluate the feasibility, appropriateness, and acceptability of the online version of the Nuestras Familias intervention.

Juntos: A Pilot Test of a Dating Violence Intervention for Latine Families

In this trial, we will be pilot-testing a family-based dating violence prevention program for Latine caregivers and adolescents. Participants will be randomized 1:1 to receive a community-based 6 week intervention or to a wait-list control where they will receive a resource guide.

Effect of the MIROKI Companion Robot on Anxiety in Pediatric Radiotherapy

Pediatric radiotherapy is an anxiety-provoking situation that can, on one hand, impair the child's cooperation and require sedation, and on the other hand,burden the care pathway by generating significant anxiety in both the child and their parents. Companion robots represent an innovative avenue for patient support, but they have never been evaluated in the context of radiotherapy. This study examines the effect of MIROKI, the first social robot capable of communication through a Large Multimodal Model (LMM), on children's state anxiety during radiotherapy. An experimental single-case design (SCED) will compare phases with and without the robot (withdrawal/reversal), both in the waiting room and in the irradiation bunker. The primary outcome variable is anxiety, assessed in several ways: through questionnaires at the beginning and end of treatment; through an objective measure of cardiac activity (heart rate in bpm) during the radiotherapy session, with or without the MIROKI robot; and through an observational grid assessing the child's behavior. The intensive repeated measure (bpm) constitutes the preferred variable in this SCED design, while behavioral observation and anxiety questionnaires will support interpretation. The results could pave the way for reducing sedation and improving the overall care pathway in pediatric radiotherapy.

Pilot Trial of Clinic-based Dating Violence Prevention Program for Adolescents and Caregivers

ETHR V 2.0 pilot trial is a one-arm, multi-site pilot trial to assess the acceptability and feasibility of Engaging Together for Healthy Relationships, a caregiver-adolescent dating violence prevention program delivered within pediatric primary care.

Impact of Implementing Reach Out and Read in the Neonatal Intensive Care Unit

This is a pre/post quasi-interventional study with two arms. First, a baseline cohort of parent-infant dyads admitted to the Neonatal Intensive Care Unit (NICU) were enrolled and surveyed at three timepoints (admission, discharge, and one-month post-discharge) to characterize baseline habits, attitudes, and barriers toward shared reading in the NICU in the absence of a shared reading program. Reach Out and Read (ROR) in the NICU, a shared reading program modified from the national ROR outpatient program to the NICU setting was then implemented. Following program implementation, a subsequent cohort of parent-infant dyads admitted to the NICU were enrolled (the "ROR" cohort) and surveyed at the same three timepoints. Feasibility, acceptability, and preliminary efficacy of ROR NICU to promote shared reading in the NICU were evaluated.

CFT Guided Self-help Intervention: Parents of Autistic Children

This research will aim to test how practical, achievable and effective a brief, guided, self-help compassion focused intervention is for parents of autistic children aged 6-17 years old. The demands of parenting can be rewarding but also challenging, and it is known that parents of autistic children experience additional pressures. As a result of this, parents of autistic children may be more likely to experience increased stress, anxiety, low mood and lower quality of life, compared to those parenting children who are not autistic. There has been only a small amount of research so far regarding whether interventions that focus on building compassion, would be beneficial to parents of autistic children. The purpose of this study is to test whether a short, self-guided compassion-focused intervention is practical, achievable and effective for parents of autistic children. The intervention is based on Compassion Focused Therapy (CFT) and involves reading workbook material and listening to audio tracks. There will also be some questionnaires to complete and 30-minute weekly support calls with the lead researcher. This intervention was adapted previously, from an intervention for parents in general, to be more suitable and focused on the needs of parents of autistic children. This study will be the first time the adapted intervention has been used by parents. The intervention will be tested by 6-8 parents and will be about 13 weeks long. We will collect some demographic data at the start of the study, and there will be the opportunity to complete an evaluation questionnaire.

Impact and Lived Experience of Parents of a Child With a Large or Giant Congenital Melanocytic Nevus

The goal of this observational study is to describe the experiences of parents at the birth of a child with a large or giant congenital melanocytic nevus through semi-structured interviews, and to identify potential intervention strategies to improve their care and support.

Adapting The Fear Of Recurrence Therapy (FORT) for Parents and Establishing Acceptability and Feasibility

Clinical levels of fear of cancer recurrence (FCR) affect up to 59% of adult cancer survivors. Family caregivers experience equal or greater levels of FCR, which has been linked to lower quality of life and increased distress. FCR can be addressed in cancer survivors with brief interventions. However, none of these interventions have been tested with parents of childhood cancer survivors. This is an urgent gap: the survival rates of childhood cancer have increased more rapidly than for adult cancers, resulting in a growing population of childhood cancer survivors who, along with their families, need support. The goals of this pilot study are to demonstrate 1) that a newly adapted intervention of FORT (Parent-FORT) is feasible (i.e., participant recruitment, attendance and participation) and acceptable (i.e., parent satisfaction of the intervention) for a larger study, and 2) the clinical implications of Parent-FORT on fear of cancer recurrence (FCR) and quality of life in parents of childhood cancer survivors. Parents will be randomly assigned to participate in the Parent-FORT intervention immediately or a three-month waitlist control group. They will complete a questionnaire package before and after the intervention, as well as at a three month follow up. This study will help bridge an important gap in bringing evidence-based care to parents who have never been offered help before for their FCR.

Cognitive-Based Behavior Change Training Program

This study will be conducted to determine the effects of the Parent Education Program Based on the Cognitive Development of the Child, which is applied to the parents of preschool children with behavioral problems, on the attitudes and stress levels of the parents and the problematic behaviors of the children. The purpose of this study has two dimensions; Dimension 1: The 'Parent Education Program Based on the Cognitive Development of the Child', which is planned to be developed for the purpose of measuring the attitudes, stress levels of the parents and the effects on the problematic behaviors of the children. The development of the program was based on Jean Piaget's theory of cognitive development. Dimension: It is experimental. The aim is to reveal the effectiveness of the Parent Education Program, which will be applied to the parents of children with behavioral problems. There are parent training programs developed for children with behavioral problems in the preschool period. However, the lack of parent studies based on the child's cognitive development reveals the rationale and importance of this study.

The Effect of Parental Presence on the Child's Comfort and Physiologic Parameters in PICU

The study was planned to be conducted and completed within 6 months after ethics committee approval was obtained. The research is a prospective, quasi-experimental study. The population of the study will consist of children hospitalized in the Pediatric Intensive Care Unit of SBU, Izmir Dr. Behçet Uz Pediatric Diseases and Surgery Training and Research Hospital. Randomization of children will be done to determine which children's data will be followed on the relevant visit day. Physiologic parameters including respiratory rate, pulse rate, oxygen saturation, body temperature, blood pressure and comfort levels of the children will be evaluated just before, during and after the parental visit (1st minute and 5th minute) and compared with those before the parental visit. All observations will be made by the same nurse to avoid bias in the study.