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

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.

Study Overview

• Status: Completed
• Conditions: Stem Cell Transplantation
• Intervention / Treatment: Behavioral: Bright Ideas Problem-Solving Skills Training

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Children's Hospital Los Angeles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Standard of care.
Experimental: Problem-Solving Skills Training; Bright ideas problem solving skills intervention.	Behavioral: Bright 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent Problem Solving Skills	Social Problem-Solving Skills Inventory-Revised Short Form	Baseline to 180 days
Parent Negative Affectivity	Profile of Mood States Short Form	Baseline to 180 days
Parent Anxiety	Beck Anxiety Inventory	Baseline to 180 days
Parent Depression	Beck Depression Inventory	Baseline to 180 days
Parent Post-traumatic Stress	Impact of events scale revised	Baseline to 180 days
Children Symptom Burden	Memorial Symptoms Assessment Scale (Child Version & Parent Proxy for children ages 2-6 years)	Baseline to 180 days
Children Health-Related Quality of Life	PedsQL Cancer Module (Child Version & Parent Proxy for children ages 2-4 years)	Baseline to 180 days

Collaborators and Investigators

• Sponsor: Children's Hospital Los Angeles
• Investigators: Principal Investigator: Heather Bemis, Children's Hospital Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2020
• Primary Completion (Actual): May 23, 2023
• Study Completion (Actual): May 23, 2023

Study Registration Dates

• First Submitted: October 20, 2025
• First Submitted That Met QC Criteria: October 20, 2025
• First Posted (Estimated): October 22, 2025

Study Record Updates

• Last Update Posted (Actual): October 23, 2025
• Last Update Submitted That Met QC Criteria: October 21, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: behavioral intervention; Problem-Solving Skills Training; Parent or caregiver support
• Other Study ID Numbers: CHLA-20-00276

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No