Problem-Solving Skills Training for Parents of Children Undergoing Hematopoietic Stem Cell Transplantation: A Feasibility Study

Children's Hospital Los Angeles

Status: Completed

Conditions: Stem Cell Transplantation

Treatments: Behavioral: Bright Ideas Problem-Solving Skills Training

Study type: Interventional

Funder types: Other

Identifiers

NCT07219524

CHLA-20-00276

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Exclusion Criteria:

• Child or adolescent refusal to participate
• Parent age less than 18 years.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Control

No Intervention group

Description:

Standard of care.

Problem-Solving Skills Training

Experimental group

Description:

Bright ideas problem solving skills intervention.

Treatment:

Behavioral: Bright Ideas Problem-Solving Skills Training