Clinical trial NCT05899998: Bright IDEAS for Pediatric Palliative Care: A Problem-Solving Skills Intervention to Empower Parent Resilience
Official title: Bright IDEAS for Pediatric Palliative Care: A Problem-Solving Skills Intervention to Empower Parent Resilience
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychological Distress
Quality of Life
Keywords: Depressive Symptoms
Anxiety
Post-Traumatic Stress
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of Bright IDEAS for parents
timeFrame: Baseline to 12 weeks
measure: Parent Problem-Solving skills
timeFrame: Baseline to 16 weeks
measure: Anxiety symptoms
timeFrame: Baseline to 16 weeks
measure: Depression symptoms
timeFrame: Baseline to 16 weeks
measure: Traumatic stress symptoms
timeFrame: Baseline to 16 weeks
Secondary outcomes:
measure: Parent Wellbeing
timeFrame: Baseline to 16 weeks
measure: Child Quality of Life (QoL) Parent Proxy 0-7 years old
timeFrame: Baseline to 16 weeks
measure: Child Quality of Life (QoL) Parent Proxy 8+ years old
timeFrame: Baseline to 16 weeks
measure: Child Quality of Life (QoL) Child Self-Report
timeFrame: Baseline to 16 weeks
Other outcomes:
measure: Bright IDEAS Acceptability
timeFrame: Between Time 2 and Time 3, up to 16 weeks
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Heather Bemis, PhD
role: PRINCIPAL_INVESTIGATOR
References: