Stem Cell Transplantation
Conditions
Keywords
Problem-Solving Skills Training, Parent or caregiver support, behavioral intervention
Brief summary
The goal of this clinical trial is to test the feasibility and acceptability of the Bright IDEAS problem-solving skills training (PSST) intervention for parents of children undergoing hematopoietic stem cell transplantation (HSCT). The main question aims to answer: * Determine the feasibility and acceptability of a multimodal PSST intervention for English and Spanish-speaking parents of children and adolescents undergoing autologous and allogeneic HSCT using a randomized controlled trial design and mixed methods approach to evaluation * To evaluate the effectiveness of a PSST intervention on PSS acquisition and psychological distress compared to a control group of parents receiving non-directive psychosocial care (n=25). * To explore the effect of the parent PSST on child quality of life (QoL) and self-reported symptoms, mediated by parent psychological distress If there is a comparison group: Researchers will compare PSST intervention usual or standard psychosocial care. Participants will complete 6-8 sessions of intervention. All participants will complete surveys.
Interventions
BEHAVIORALBright Ideas Problem-Solving Skills Training
Intervention materials include instructor and user manuals, a brochure, and worksheets to be completed by the parent caregiver, initially with the help of the interventionist, during four weekly face-to-face (F2F) sessions
Sponsors
Children's Hospital Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Children Inclusion Criteria: * Male and females of any race or ethnicity, ages 0 to 21 years * Allogeneic or autologous HSCT planned with reduced intensity or myeloablative conditioning
Exclusion criteria
* Concurrent enrollment on a research study testing psychoeducational interventions for parents and/or patients Parent Inclusion Criteria: * One parent or primary caregiver per child * Able to speak, read, and write English or Spanish, and give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Bright IDEAS for parents | Baseline to 180 days | Percent eligible participants who consent/assent to participate and Number of sessions completed by enrolled participants. |
| Bright IDEAS Acceptability | Between day 60 and day 90 | Qualitative Interviews will assess participant satisfaction with the intervention format, timing, and content; impact; barriers; and suggestions for refinement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parent Anxiety | Baseline to 180 days | Beck Anxiety Inventory |
| Parent Depression | Baseline to 180 days | Beck Depression Inventory |
| Parent Problem Solving Skills | Baseline to 180 days | Social Problem-Solving Skills Inventory-Revised Short Form |
| Children Symptom Burden | Baseline to 180 days | Memorial Symptoms Assessment Scale (Child Version & Parent Proxy for children ages 2-6 years) |
| Children Health-Related Quality of Life | Baseline to 180 days | PedsQL Cancer Module (Child Version & Parent Proxy for children ages 2-4 years) |
| Parent Post-traumatic Stress | Baseline to 180 days | Impact of events scale revised |
| Parent Negative Affectivity | Baseline to 180 days | Profile of Mood States Short Form |
Countries
United States
Outcome results
None listed