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Completed

NCT Number: NCT07219524

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.

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Key information

Conditions

Stem Cell Transplantation

Age range

0 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Feasibility of Bright IDEAS for parents

    Time frame: Baseline to 180 days

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

  2. Bright IDEAS Acceptability

    Time frame: 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 outcomes

  1. Parent Problem Solving Skills

    Time frame: Baseline to 180 days

    Social Problem-Solving Skills Inventory-Revised Short Form

  2. Parent Negative Affectivity

    Time frame: Baseline to 180 days

    Profile of Mood States Short Form

  3. Parent Anxiety

    Time frame: Baseline to 180 days

    Beck Anxiety Inventory

  4. Parent Depression

    Time frame: Baseline to 180 days

    Beck Depression Inventory

  5. Parent Post-traumatic Stress

    Time frame: Baseline to 180 days

    Impact of events scale revised

  6. Children Symptom Burden

    Time frame: Baseline to 180 days

    Memorial Symptoms Assessment Scale (Child Version & Parent Proxy for children ages 2-6 years)

  7. Children Health-Related Quality of Life

    Time frame: Baseline to 180 days

    PedsQL Cancer Module (Child Version & Parent Proxy for children ages 2-4 years)

Sponsors and collaborators

Lead sponsor

Children's Hospital Los Angeles

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 22, 2025
Registry last updated
Oct 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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