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

Trial Summary

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 data supports the effectiveness of the treatment Bright IDEAS for reducing parental psychological distress?

Research shows that the Bright IDEAS treatment, which focuses on problem-solving skills training, has been effective in reducing distress and improving problem-solving skills in caregivers of children with cancer. Multiple studies involving over 1400 caregivers have demonstrated its success in alleviating high levels of distress. ^{1 2 3 4 5}

Is the Bright IDEAS treatment safe for humans?

The research articles provided do not contain specific safety data for the Bright IDEAS treatment or its related interventions like Problem-Solving Skills Training (PSST). ^{6 7 8 9 10}

How is the Bright IDEAS treatment different from other treatments for parental psychological distress?

Bright IDEAS is unique because it focuses on teaching problem-solving skills to help parents manage their stress and emotions, especially when dealing with a child's serious illness like cancer. Unlike other treatments that might focus on general support or medication, this approach specifically enhances problem-solving abilities, which in turn reduces anxiety and depression. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Heather Bemis, PhD

Principal Investigator

Children's Hospital Los Angeles

Eligibility Criteria

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

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.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Responsivity to Problem-Solving Skills Training in Mothers of Children With Cancer. [2021]

2. United States 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Problem-solving skills training for mothers of children with newly diagnosed cancer: a randomized trial. [2022]

4. United States 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. [2023]

5. United States 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Parent-child interaction therapy: a comparison of standard and abbreviated treatments for oppositional defiant preschoolers. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Parent-child interaction therapy: one- and two-year follow-up of standard and abbreviated treatments for oppositional preschoolers. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Behavioral Parent Training for ADHD Reduces Situational Severity of Child Noncompliance and Related Parental Stress. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Problem-solving intervention for caregivers of children with mental health problems. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Behavioral Parent Training in Infancy: A Window of Opportunity for High-Risk Families. [2019]