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

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Psychological Distress
• Intervention / Treatment: Behavioral: Bright IDEAS

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mikela Ritter; Phone Number: 3233613085; Email: mritter@chla.usc.edu
• Study Contact Backup: Name: Heather Bemis, PhD; Phone Number: 3233614026; Email: hbemis@chla.usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Recruiting
      • Children's Hospital Los Angeles
      • Contact: Mikela Ritter; Phone Number: 14789 323-361-4789; Email: mdritter@usc.edu

Participation Criteria

Eligibility Criteria

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

Description

Parent

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Inclusion Criteria:

• Children 8-17 years of age whose primary caregiver has consented to participate
• Able to read and write English or Spanish and assent

Exclusion Criteria:

• Parent refusal to participate

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: Standard of Care
Experimental: Bright IDEAS	Behavioral: Bright IDEAS; 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.

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 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent Wellbeing	CarerQoL. The CarerQOL evaluates care-related quality of life and incorporates caregiving burden as well as positive effects of caregiving. It consists of 7 items related to caregiving burdens, fulfillment, or support that participants self-rate on a 3-point qualitative scale ("No", "Some" or "A lot of") as well as 1 item in which the respondent rates their current overall happiness on a 10-point visual analog scale with higher scores corresponding to higher positive affect (0 = "completely unhappy" to 10 = "completely happy"). The measure will be slightly adapted to clarify reference to the child as the care receiver.	Baseline to 16 weeks
Child Quality of Life (QoL) Parent Proxy 0-7 years old	PROMIS® Early Childhood Parent Report Global Health 8a contains 8 items, assessing global health and development. All items use a 5-point Likert scale (1 = Poor to 5 = Excellent). Total raw sum 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 better reported wellbeing.	Baseline to 16 weeks
Child Quality of Life (QoL) Parent Proxy 8+ years old	PROMIS® Parent Proxy Scale v1.0 Global Health 7+2. This measure contains 9 items in total, including 7 items assessing global health (physical and mental wellbeing), and 1 item each related to fatigue and pain burden. All items are completed on a 5-point Likert scale (anchors are 1= Poor to 5 = Excellent, or 1 = Never to 5 = Always or Almost always, depending on the domain). Total raw sum scores for global health range from 7-35 and are converted to standardized T-scores with a mean of 50 and standard deviation of 10. Raw scores for the fatigue and pain items each range from 1-4 and are each separately converted to standardized T-scores with a mean of 50 and standard deviation of 10. Higher scores indicate better reported wellbeing and lower fatigue and pain, respectively.	Baseline to 16 weeks
Child Quality of Life (QoL) Child Self-Report	Participating parents' child (ages 8+) who are medically and cognitively able will be invited to complete the PROMIS® Pediatric Scale v1.0 Global Health 7+2 to measure self-reported quality of life. This measure contains 9 items in total, including 7 items assessing global health (physical and mental wellbeing), and 1 item each related to fatigue and pain burden. All items are completed on a 5-point Likert scale (anchors are 1= Poor to 5 = Excellent, or 1 = Never to 5 = Always or Almost always, depending on the domain). Total raw sum scores for global health range from 7-35 and are converted to standardized T-scores with a mean of 50 and standard deviation of 10. Raw scores for the fatigue and pain items each range from 1-4 and are each separately converted to standardized T-scores with a mean of 50 and standard deviation of 10. Higher scores indicate better reported wellbeing and lower fatigue and pain, respectively.	Baseline to 16 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bright IDEAS Acceptability	Qualitative Interviews will assess participant satisfaction with the intervention format, timing, and content; impact; barriers; and suggestions for refinement.	Between Time 2 and Time 3, up to 16 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: May 26, 2023
• First Submitted That Met QC Criteria: June 7, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Anxiety; Depressive Symptoms; Post-Traumatic Stress
• Other Study ID Numbers: CHLA-23-00162

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