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

NCT07219524 | Completed

• 1 other identifier: CHLA-20-00276
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Stem Cell Transplantation

Keywords

Problem-Solving Skills Training; Parent or caregiver support; behavioral intervention

Outcome Measures

Primary Outcomes (2)

• Feasibility of Bright IDEAS for parents

  Percent eligible participants who consent/assent to participate and Number of sessions completed by enrolled participants.

  Baseline to 180 days

• Bright IDEAS Acceptability

  Qualitative Interviews will assess participant satisfaction with the intervention format, timing, and content; impact; barriers; and suggestions for refinement.

  Between day 60 and day 90

Secondary Outcomes (7)

• Parent Problem Solving Skills

  Baseline to 180 days

• Parent Negative Affectivity

  Baseline to 180 days

• Parent Anxiety

  Baseline to 180 days

• Parent Depression

  Baseline to 180 days

• Parent Post-traumatic Stress

  Baseline to 180 days

Study Arms (2)

Control

NO INTERVENTION

Standard of care.

Problem-Solving Skills Training

EXPERIMENTAL

Bright ideas problem solving skills intervention.

Behavioral: Bright Ideas Problem-Solving Skills Training

Interventions

Bright Ideas Problem-Solving Skills Training BEHAVIORAL

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

Problem-Solving Skills Training

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and females of any race or ethnicity, ages 0 to 21 years
• Allogeneic or autologous HSCT planned with reduced intensity or myeloablative conditioning

You may not qualify if:

• Concurrent enrollment on a research study testing psychoeducational interventions for parents and/or patients
• Parent
• One parent or primary caregiver per child
• Able to speak, read, and write English or Spanish, and give informed consent
• Child or adolescent refusal to participate
• Parent age less than 18 years.

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Study Officials

• Heather Bemis

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Pediatrics

Study Record Dates

• First Submitted: October 20, 2025
• First Posted: October 22, 2025
• Study Start: November 11, 2020
• Primary Completion: May 23, 2023
• Study Completion: May 23, 2023
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)