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

NCT ID: NCT07219524

Last Updated: 2025-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-11

Study Completion Date

2023-05-23

Brief Summary

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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.

Detailed Description

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Conditions

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Stem Cell Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control

Standard of care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Problem-Solving Skills Training

Bright ideas problem solving skills intervention.

Group Type EXPERIMENTAL

Bright Ideas Problem-Solving Skills Training

Intervention Type 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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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


* One parent or primary caregiver per child
* Able to speak, read, and write English or Spanish, and give informed consent

Exclusion Criteria

* Concurrent enrollment on a research study testing psychoeducational interventions for parents and/or patients

Parent


* Child or adolescent refusal to participate
* Parent age less than 18 years.
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Bemis, Heather

Assistant Professor of Clinical Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heather Bemis

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Los Angeles

Locations

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Children's Hospital Los Angeles

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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CHLA-20-00276

Identifier Type: -

Identifier Source: org_study_id

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