Bright IDEAS for Parental Psychological Distress

Overseen By Heather Bemis, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Los Angeles

Disqualifiers: Under 18, Other study, Child life expectancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a program called bright IDEAS, designed to help parents of children in palliative care by teaching problem-solving skills. Researchers aim to determine if this program reduces stress and emotional distress compared to the usual support in palliative care. Participants will attend 6-8 sessions and express their feelings through surveys. Parents of children who have recently received palliative care support and can communicate in English or Spanish may be suitable for this trial. As an unphased trial, this study provides a unique opportunity for parents to gain valuable skills and support during a challenging time.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on psychological support, so it's unlikely to require changes to your medication, but you should confirm with the trial organizers.

What prior data suggests that the bright IDEAS program is safe for parents of children in palliative care?

Research shows that the Bright IDEAS problem-solving skills training receives positive feedback from participants. Studies have found that this training significantly reduces anxiety, depression, and stress related to trauma. Over 900 mothers have participated in similar studies using this program, with more than 125 experiencing positive results without serious side effects.

The Bright IDEAS program employs a simple five-step method to help people manage stress in challenging situations, such as when a child is sick. As a training program rather than a medication, it carries a very low risk of physical side effects. Participants typically report improved mental health without major negative experiences.

Overall, evidence suggests that Bright IDEAS is a safe way to reduce stress and emotional distress in parents, making it a promising choice for those seeking to manage stress during difficult times. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Bright IDEAS approach because it offers a fresh take on helping parents manage psychological distress. Unlike traditional talk therapy or medication, Bright IDEAS is a problem-solving skills training program specifically designed to help parents of children with serious illnesses cope more effectively. The approach empowers parents by providing them with practical tools to tackle day-to-day challenges, potentially reducing stress more effectively than standard care options. This innovative focus on skill-building is what sets Bright IDEAS apart and offers hope for more personalized and impactful support for these parents.

What evidence suggests that the Bright IDEAS intervention is effective for reducing parental psychological distress?

Research shows that the Bright IDEAS program, which participants in this trial may receive, helps reduce emotional stress in caregivers of children with serious illnesses. Studies have found that it improves problem-solving skills and reduces depression and stress in parents. Specifically, Bright IDEAS has effectively eased stress for parents of children newly diagnosed with cancer. Participants often report feeling less overwhelmed and more capable of handling challenges after completing the program. Various groups, including Latina immigrant mothers, have experienced significant stress reductions from the program. ^{1 3 5 6 7}

Who Is on the Research Team?

Heather Bemis, PhD

Principal Investigator

Children's Hospital Los Angeles

Are You a Good Fit for This Trial?

This trial is for parents or primary caregivers, who can communicate in English or Spanish, of children aged 0-21 receiving palliative care. The child must have had a consult from the Comfort and Palliative Care team within the last month. Parents under 18 or those participating in similar studies are excluded.

Inclusion Criteria

Able to speak, read, and write English or Spanish, and give informed consent

I am the parent or guardian of a child aged 0-21, regardless of their health condition.

I am the only caregiver or parent participating.

Exclusion Criteria

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

My parents have not agreed to let me join the trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in 6-8 sessions of the bright IDEAS program to improve problem-solving skills

12 weeks

6-8 sessions (in-person or virtual)

Follow-up

Participants are monitored for psychological distress and well-being after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bright IDEAS

Trial Overview

The study tests 'Bright IDEAS,' a problem-solving skills training program for parents of children in palliative care. It checks if this training is practical and helpful compared to standard support by measuring changes in parental psychological distress and well-being through self-report measures.

How Is the Trial Designed?

Group I: Bright IDEAS Experimental Treatment 1 Intervention

Group II: Standard of Care Active Control 1 Intervention

Bright IDEAS is already approved in United States for the following indications:

Approved in United States as Bright IDEAS for:

• Pediatric palliative care support for parents

Who Is Running the Clinical Trial?

Children's Hospital Los Angeles

Lead Sponsor

Trials

257

Recruited

5,075,000+

Published Research Related to This Trial

In a study involving 54 preschool-aged children with conduct problems, both standard and abbreviated Parent-Child Interaction Therapy (PCIT) showed long-term benefits, with treatment gains maintained at 1- and 2-year follow-ups for nearly all families.

The results indicate that the abbreviated form of PCIT is as effective as the standard version in helping families manage early conduct problems in children, suggesting it could be a viable option for treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent-child interaction therapy: one- and two-year follow-up of standard and abbreviated treatments for oppositional preschoolers. Nixon, RD., Sweeney, L., Erickson, DB., et al.[2019]

In a study involving 54 behaviorally disturbed preschool-aged children, both standard and modified parent-child interaction therapy (PCIT) significantly reduced externalizing behaviors and improved parental stress and discipline practices compared to a waitlist control group.

While the standard PCIT showed superior immediate effects post-treatment, by the 6-month follow-up, both treatment groups demonstrated comparable outcomes, suggesting that abbreviated PCIT can be an effective alternative for families with young children exhibiting conduct problems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent-child interaction therapy: a comparison of standard and abbreviated treatments for oppositional defiant preschoolers. Nixon, RD., Sweeney, L., Erickson, DB., et al.[2022]

The Bright IDEAS (BI) problem-solving skills training has been shown to effectively reduce distress in caregivers of children newly diagnosed with cancer, based on data from over 1400 caregivers in four multisite randomized clinical trials.

The training program successfully educated 209 psychosocial professionals across 134 sites, who have since provided BI to 545 individuals, although further efforts are needed to integrate BI into routine pediatric oncology care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dissemination of an evidence-based behavioral intervention to alleviate distress in caregivers of children recently diagnosed with cancer: Bright IDEAS. Voll, M., Fairclough, DL., Morrato, EH., et al.[2023]

The Bright IDEAS problem-solving skills training (PSST) intervention significantly reduces anxiety, depression, and post-traumatic stress symptoms in mothers of children recently diagnosed with cancer, with lasting benefits observed at a 3-month follow-up after the intervention.

In contrast to the nondirective support (NDS) intervention, which only provided temporary benefits during the sessions, PSST led to continued improvements in emotional well-being, highlighting the importance of teaching coping skills for long-term family resilience during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Specificity of problem-solving skills training in mothers of children newly diagnosed with cancer: results of a multisite randomized clinical trial. Sahler, OJ., Dolgin, MJ., Phipps, S., et al.[2022]

In a study of 154 mothers participating in the Bright IDEAS problem-solving skills training program, 33% showed significant improvement in problem-solving skills immediately after treatment, with this rate increasing to 39% at follow-up.

Lower baseline problem-solving skills were a strong predictor of greater improvement, suggesting that targeting individuals with poorer skills may enhance the effectiveness of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Responsivity to Problem-Solving Skills Training in Mothers of Children With Cancer. Dolgin, MJ., Devine, KA., Tzur-Bitan, D., et al.[2021]

Behavioral parent training (BPT) significantly reduced the frequency and severity of problematic behaviors in children with ADHD, particularly in areas like chores, homework, and peer interactions, based on data from 304 parents.

Parents reported a notable decrease in stress related to parenting their child with ADHD after participating in BPT, indicating that this intervention not only helps children but also supports parental well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral Parent Training for ADHD Reduces Situational Severity of Child Noncompliance and Related Parental Stress. Ciesielski, HA., Loren, REA., Tamm, L.[2021]

The Building Our Solutions and Connections (BOSC) program showed promising feasibility and acceptability in enhancing problem-solving skills among primary caregivers of children with mental health issues, with 30 caregivers participating in the intervention group.

Three months after the intervention, there were small effect sizes for reducing caregiver burden (0.07) and increasing personal control (0.08), indicating that while the changes were positive, they may not be large enough to suggest significant clinical impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Problem-solving intervention for caregivers of children with mental health problems. Gerkensmeyer, JE., Johnson, CS., Scott, EL., et al.[2021]

A brief home-based adaptation of Parent-child Interaction Therapy (PCIT) significantly improved infant compliance and reduced behavior problems in infants from high-risk families, as observed at a 6-month follow-up.

Mothers who participated in the intervention exhibited more positive and fewer negative interactions with their infants during play, suggesting enhanced parenting behaviors, although there was no significant change in parenting stress levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral Parent Training in Infancy: A Window of Opportunity for High-Risk Families. Bagner, DM., Coxe, S., Hungerford, GM., et al.[2019]

The Bright IDEAS problem-solving skills training (BI) was successfully adapted for caregivers of children with sickle cell disease, achieving a high recruitment rate of 94% (72 participants) and a reasonable retention rate of 49%, with 35 caregivers completing the program.

Caregivers who completed the BI program reported significant improvements in their problem-solving skills immediately after and three months post-intervention, while initial levels of distress were low and remained stable over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bright IDEAS problem-solving skills training for caregivers of children with sickle cell disease: A two-site pilot feasibility trial. Young, M., Voll, M., Noll, RB., et al.[2023]

A study involving 92 mothers of newly diagnosed pediatric cancer patients showed that an 8-week problem-solving skills training (PSST) intervention significantly improved their problem-solving abilities and reduced negative feelings like depression and anxiety compared to standard care.

The improvement in mood was largely linked to better problem-solving behaviors, with the greatest benefits seen in constructive problem-solving, suggesting that enhancing these skills can effectively support mothers facing the stress of their children's serious illnesses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Problem-solving skills training for mothers of children with newly diagnosed cancer: a randomized trial. Sahler, OJ., Varni, JW., Fairclough, DL., et al.[2022]

Citations

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ebccp.cancercontrol.cancer.gov

ebccp.cancercontrol.cancer.gov/programDetails.do?programId=546012

Bright IDEAS: Problem-Solving Skills Training

Designed to reduce the emotional distress in mothers of children ... The study showed improvements in various problem-solving skills and mood and ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10762633/

Problem-Solving Skills Training for Parents of Children With ...

PSST was associated with improvements in parental problem-solving skills; decreased parental depression, distress, posttraumatic stress, and parenting stress.

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withpower.com

withpower.com/trial/phase-psychological-distress-5-2023-b0e89

Bright IDEAS for Parental Psychological Distress

The Bright IDEAS (BI) problem-solving skills training has been shown to effectively reduce distress in caregivers of children newly diagnosed with cancer, ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01711944

NCT01711944 | Online Problem Solving Skills Training

It has been shown to significantly decrease mothers' distress and to particularly benefit Latina immigrants. This past spring, the NCI/NIH designated Bright ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9264826/

Feasibility and Acceptability of Bright IDEAS-Young Adults

This study aimed to evaluate if an adapted version of Bright IDEAS was feasible and acceptable to young adults with cancer.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3607672/

Specificity of Problem-Solving Skills Training in Mothers of ...

Bright IDEAS, a problem-solving skills training (PSST) intervention, has been shown to decrease negative affectivity (anxiety, depression, post- ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S1551714424002398

Problem-Solving Skills Training to Reduce Distress among ...

This randomized trial will determine the efficacy of Bright IDEAS-YA on psychosocial outcomes for young adults newly diagnosed with cancer.