Stem Cell TransplantationNCT07219524
Problem-Solving Skills Training for Parents of Children Undergoing Hematopoietic Stem Cell Transplantation: A Feasibility Study
A study testing Bright Ideas Problem-Solving Skills Training in people with Stem Cell Transplantation, run by Children's Hospital Los Angeles at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Stem Cell Transplantation
- What is being tested?
- Bright Ideas Problem-Solving Skills Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2020to 23 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Los Angeles
Los Angeles, California, 90027
About this 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
Read more
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
- Being tested
- Bright Ideas Problem-Solving Skills Training
- Keywords
- Problem-Solving Skills Training, Parent or caregiver support, behavioral intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright Ideas Problem-Solving Skills TrainingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard of care. |
| Problem-Solving Skills Training | Experimental | Bright ideas problem solving skills intervention. Receives: Behavioral: Bright Ideas Problem-Solving Skills Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Bright IDEAS for parents
Percent eligible participants who consent/assent to participate and Number of sessions completed by enrolled participants.
Measured: 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.
Measured: Between day 60 and day 90
Secondary outcomes (7)
Parent Problem Solving Skills
Social Problem-Solving Skills Inventory-Revised Short Form
Measured: Baseline to 180 days
Parent Negative Affectivity
Profile of Mood States Short Form
Measured: Baseline to 180 days
Parent Anxiety
Beck Anxiety Inventory
Measured: Baseline to 180 days
Parent Depression
Beck Depression Inventory
Measured: Baseline to 180 days
Parent Post-traumatic Stress
Impact of events scale revised
Measured: Baseline to 180 days
Children Symptom Burden
Memorial Symptoms Assessment Scale (Child Version \& Parent Proxy for children ages 2-6 years)
Measured: Baseline to 180 days
Children Health-Related Quality of Life
PedsQL Cancer Module (Child Version \& Parent Proxy for children ages 2-4 years)
Measured: Baseline to 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2025
- Study start11 Nov 2020
- Primary completion23 May 2023
- Study completion23 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bemis, Heather, Children's Hospital Los Angeles
- Investigators
- Heather Bemis, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219524
- Sponsor's protocol ID
- CHLA-20-00276
- Status last verified
- Oct 2025
- First submitted
- 20 Oct 2025
- Last updated
- 23 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Problem-Solving Skills Training for Parents of Children Undergoing Hematopoietic Stem Cell Transplantation: A Feasibility Study
- ClinicalTrials.gov ID
- NCT07219524
- Acronym / sponsor ID
- CHLA-20-00276
- Conditions
- Stem Cell Transplantation
- Keywords
- Problem-Solving Skills Training, Parent or caregiver support, behavioral intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- 23 May 2023 (actual)
- Study completion
- 23 May 2023 (actual)
- First posted
- 22 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard of care. |
| Problem-Solving Skills Training | Experimental | Behavioral: Bright Ideas Problem-Solving Skills TrainingBright ideas problem solving skills intervention. |
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bright Ideas Problem-Solving Skills TrainingIntervention 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 | Behavioural | Problem-Solving Skills Training |
Primary outcome
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.
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.
7 secondary outcomes
Parent Problem Solving Skills
Time frame: Baseline to 180 days
Parent Negative Affectivity
Time frame: Baseline to 180 days
Parent Anxiety
Time frame: Baseline to 180 days
Parent Depression
Time frame: Baseline to 180 days
Parent Post-traumatic Stress
Time frame: Baseline to 180 days
Children Symptom Burden
Time frame: Baseline to 180 days
Children Health-Related Quality of Life
Time frame: Baseline to 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Bemis principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bright Ideas Problem-Solving Skills Training in people with Stem Cell Transplantation, run by Children's Hospital Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Bright IDEAS for parents (time frame: Baseline to 180 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2025.