Bright IDEAS for Pediatric Palliative Care: A Problem-Solving Skills Intervention to Empower Parent Resilience

NCT05899998 | Active Not Recruiting

• 1 other identifier: CHLA-23-00162
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this or clinical trial is to test in the feasibility, acceptability and preliminary efficacy of the bright IDEAS problem solving skills training for parents of children in palliative care. The main questions it aims to answer are:

• Is bright IDEAS problem solving skills training feasible and acceptable for parents of children referred to pediatric palliative care?
• Does bright IDEAS reduce psychological distress in parents compared to parents receiving standard palliative care support? Participants will:
• Participate in 6-8 sessions of the bright IDEAS program.
• Complete self report measures of psychological distress and well being. If there is a comparison group: Researchers will compare bright IDEAS to standard palliative care support.

Conditions

Psychological Distress; Quality of Life

Keywords

Depressive Symptoms; Anxiety; Post-Traumatic Stress

Outcome Measures

Primary Outcomes (5)

• Feasibility of Bright IDEAS for parents

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

  Baseline to 12 weeks

• Parent Problem-Solving skills

  Social Problem-Solving Inventory-Revised Short Form. This is a a 25-item self-report instrument that measures five dimensions of problem-solving (positive problem orientation, negative problem orientation, rational problem-solving style, impulsive/carelessness style, and avoidant style) using a five-point Likert scale (0 = "Not at All True of Me" to 4 = "Extremely True of Me"). Summary scores for each subscale as well as a Total Raw Score range from 0-20. Higher scores indicate better self-reported problem-solving skills.

  Baseline to 16 weeks

• Anxiety symptoms

  PROMIS® Anxiety Short Form-v1.0 8a. This self-report measure includes includes 8 items on which participants respond using a 5-point scale (1 = "Never" to 5 = "Always"). Total raw scores range from 8-40 and are converted to standardized T-scores with a mean of 50 and standard deviation of 10. Higher scores indicate higher levels of anxiety.

  Baseline to 16 weeks

• Depression symptoms

  PROMIS® Depression Short Form-v 1.0 8a. This self-report measure includes includes 8 items on which participants respond using a 5-point scale (1 = "Never" to 5 = "Always"). Total raw scores range from 8-40 and are converted to standardized T-scores with a mean of 50 and standard deviation of 10. Higher scores indicate higher levels of depressive symptoms.

  Baseline to 16 weeks

• Traumatic stress symptoms

  Abbreviated Posttraumatic Checklist -Civilian Version (PCL-6). This is a 6-item self-report screening measure empirically derived from the PCL-C, consisting of the most highly responsive items from each of the reexperiencing, avoidance, and hyperarousal symptom domains of the PCL-C and has previously been used with parents of children with serious illness. The PCL-6 uses a five-point Likert scale (0 = "Not at all" to 5 = "Extremely"), with total scores ranging from 6-30. Higher scores indicate higher levels of traumatic stress symptoms.

  Baseline to 16 weeks

Secondary Outcomes (4)

• Parent Wellbeing

  Baseline to 16 weeks

• Child Quality of Life (QoL) Parent Proxy 0-7 years old

  Baseline to 16 weeks

• Child Quality of Life (QoL) Parent Proxy 8+ years old

  Baseline to 16 weeks

• Child Quality of Life (QoL) Child Self-Report

  Baseline to 16 weeks

Other Outcomes (1)

• Bright IDEAS Acceptability

  Between Time 2 and Time 3, up to 16 weeks

Study Arms (2)

Bright IDEAS

EXPERIMENTAL

Behavioral: Bright IDEAS

Standard of Care

NO INTERVENTION

Interventions

Bright IDEAS BEHAVIORAL

Bright IDEAS® (Identify, Define, Evaluate, Act, See) is a problem-solving skills training program that was originally developed to alleviate distress in caregivers of children recently diagnosed with cancer. 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 and then with increasing independence.

Bright IDEAS

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Parents or legal guardians of male and female children (ages 0-21) of any race or ethnicity and of any underlying medical diagnosis
• Child received at least one consult from the Comfort and Palliative Care team within the past month
• One parent or primary caregiver per child
• Able to speak, read, and write English or Spanish, and give informed consent

You may not qualify if:

• Parent age less than 18 years old
• Concurrent enrollment on another research study testing psychoeducational interventions for parents and/or patients
• Child has an estimated life expectancy of less than 4 months at time of study recruitment
• Child
• Children 8-17 years of age whose primary caregiver has consented to participate
• Able to read and write English or Spanish and assent
• Parent refusal to participate

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Heather Bemis, PhD

  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: Principal Investigator

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 12, 2023
• Study Start: August 8, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)