Treatment Trials

7 Clinical Trials for Various Conditions

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ACTIVE_NOT_RECRUITING
Innovative Family Prevention With Latino Siblings in Disadvantaged Settings
Description

The current study is a randomized intervention trial that tests the efficacy of a family-focused sibling relationship promotion program. The study includes a treatment group and a contact-equivalent attention control condition with 288 sibling dyads and data collection with target parents, target sibling dyads, and teachers at three time points (pre-test, post-test, and 18-month follow-up). Data will be collected using a three-cohort design with 96 families in each of the three cohorts.

COMPLETED
A Behavioral Intervention With Foster Families
Description

The purpose of this study is to investigate a behavioral intervention with foster families.

COMPLETED
SIB-Time Web-application Tool for Typically Developing Siblings
Description

In the United States, over 32.7 million people have special health, developmental, and mental health concerns. Most of these people have typically developing brothers and sisters. Across the lifespan, siblings share high levels of involvement in each other's lives, and also many of the concerns that parents of children with special needs experience, including isolation, a need for information, concerns about the future, and caregiving demands. Brothers and sisters also face issues that are uniquely theirs including emotions (resentment, worry, embarrassment, guilt), peer issues, and family communication challenges. The team of researchers, developers, and consultants built and tested an assistive media enhanced web-application tool for developing knowledge, skills, and routines for attending to TD siblings' (ages 3-5) social-emotional health and well-being.

COMPLETED
Siblings in Foster Care
Description

National estimates indicate that roughly 70% of children in foster care have one or more siblings also in care. Exact percentages vary by state, but several data sources suggest that about 50% of early adolescent foster youth are placed apart from one or more of their siblings. Relationships between these siblings may be critical in providing them a sense of connection and emotional continuity as they are removed from much that is familiar (e.g. their home, parents, and friends). Historically, efforts to strengthen ties of foster children with their families have focused on adults (e.g., biological parents, grandparents). Limited research exists on the relationships of siblings in foster care. The central aim of the proposed study is to evaluate the impact of the Sibling plus Parent Management Training (SPMT) intervention as compared to Parent Management Training-only (PMT) on key constructs of sibling relationship quality, mental health, academic success, and quality of life for youth in foster care. Conducted in partnership with the Oregon DHS Foster Care program, 240 sibling dyads and their foster parents will be enrolled in six cohorts. Siblings may live together or in separate placements. Dyads will consist of (1) a target youth in care that is 11-15 years of age, and (2) a younger sibling in care who is 7-15 years of age and within 4 years of age of the target youth. Sibling dyads will be matched as living together or living apart; the matched dyads will be randomly assigned to either the SPMT or PMT-only group, with all study-enrolled foster parents receiving PMT intervention components. The SPMT intervention includes a sibling component as well as foster parent PMT. The sibling intervention component includes eight cognitive behavioral sessions of skills learning/practice, and four community activities planned by siblings with their interventionist coaches. For foster parents, there is a 4-session PMT curriculum emphasizing skills learning and practice with their study-enrolled foster child. Additional sessions are available to foster parents on request. Foster parents will also be able to access and troubleshoot PMT materials and strategies via weekly staff check-in calls, and the project website. Major wave assessments will be conducted at baseline, intervention termination (6 months), follow-along1 (6-month post-intervention) and follow-along2 (12-month post-intervention). Brief, bi-monthly phone interviews for youth and foster parents will collect service utilization data and global ratings of outcome constructs for use in growth-modeling analyses. Hierarchical Linear Models (HLM) and multiple regression analyses will be used to test (1) the prediction that SPMT siblings will improve more than PMT siblings on key outcomes, and (2) whether intervention efficacy varies by sibling placement (together vs. apart) and participant characteristics such as race, gender, and disability

TERMINATED
A Safety and Tolerability Study of CDX-301 With or Without Plerixafor for Stem Cell Mobilization in Matched Related Allogeneic Donor/Recipient Sibling Transplant Pairs
Description

This is an open-label, multicenter, prospective pilot study of CDX-301 with or without plerixafor as a stem cell mobilizer for allogeneic transplantation (stem cells that come from another person). HLA-matched sibling healthy volunteers (donors) and patients with protocol specified hematologic malignancies (recipients) will be enrolled.

COMPLETED
Evaluation of a Resiliency Intervention for Siblings of Children With Autism Spectrum Disorder (ASD)
Description

The proposed research has the following objectives: Based off findings from the "Development of a Resiliency Program for Siblings of Children with Autism Spectrum Disorder" qualitative focus group study (protocol 2019P002284), the aim is to determine the feasibility and acceptability, of an 8-session Relaxation Response Resiliency (SibChat) program for siblings of children with ASD. We primarily aim to test the preliminary effectiveness of a pilot waitlist controlled trial on improving resiliency and stress coping, This will be assessed by comparing Baseline-3 mo. scores on primary and secondary outcome measures between the Immediate and Waitlist control groups. Among participants randomized to both conditions, we secondarily aim to investigate the extent of pre-post changes in primary and secondary outcomes. Among immediate condition group only, we also aim to assess whether end-of-treatment (3 mo. post enrollment) improvements will be sustained at 6-mo. post enrollment.

Conditions
TERMINATED
Long Term Minor Sibling Donor Well-Being
Description

The goal of this research study is to understand what it is like for a young person to have a sick family member and what it is like to donate bone marrow or stem cells for a sick family member. Primary Aims: 1. Compare minor donor adjustment to minor non-donor adjustment, including anxiety, self-esteem, traumatic stress, achievement, and behavior. 2. Evaluate minor donor adjustment across time, including self -esteem, traumatic stress, anxiety, achievement, and behavior. 3. Investigate the effect of the following on donor well-being: * Donor variables: 1) the impact of the harvest, including type of harvest (needle aspiration of bone marrow or peripheral blood stem cell collection by apheresis after injection of G-CSF), pre-procedural anxiety and perceived pain; 2) age of donor at time of transplant, 3) gender, 4) preparedness for transplant, 5) sibling order (for sibling participants), and 6) donor's decision-making and ambivalence regarding donation. * Recipient variables: 1) the recipient's level of well-being or death, 2) genetic versus acquired disease types, and 3) familial relationship of donor to recipient. * Family support variables: 1) the distress of the family, 2) the quality of the relationship between the potential donor and the recipient, and 3) parent's well-being (post-traumatic stress disorder or PTSD, depression). Secondary Aim: Evaluate satisfaction with the donor program.