Parenting Intervention Program for Acute Leukemia and Lymphoblastic Lymphoma

Not currently recruiting at 2 trial locations

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Disqualifiers: Psychosis, Down's syndrome, others

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

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a high-intensity parenting program can improve learning and school performance for Latino children who have had acute leukemia or lymphoblastic lymphoma. The trial compares a high-intensity program, where parents learn skills with a bilingual therapist over several sessions, to a standard, less intensive program. It targets Latino families with children who have completed cancer treatment and returned to school. Parents or caregivers who are in daily contact with the child and speak Spanish are ideal candidates for this trial. As an unphased trial, it provides a unique opportunity for families to contribute to research that could enhance educational outcomes for children after cancer treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this high-intensity intervention program is safe for children with acute leukemia or lymphoblastic lymphoma?

Research has shown that parenting programs, such as the High-Intensity Parent Intervention Program under study, are generally safe and well-liked. Families dealing with childhood leukemia have used these programs, which typically do not cause harm or unwanted effects.

Previous studies support the safety of these programs, demonstrating they help without adding stress or problems. Although no specific negative effects have been reported for this program, the overall evidence suggests it is well-tolerated by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the High-Intensity Parent Intervention Program (HIP) because it offers a fresh approach to supporting families dealing with acute leukemia and lymphoblastic lymphoma. Unlike the standard of care, which involves a single session reviewing neurocognitive evaluations, HIP provides parents with a series of eight individualized skill training sessions. These sessions are conducted with a bilingual therapist, ensuring that language barriers don't hinder participation. This structured and intensive support aims to equip parents with better skills to help their children navigate the challenges of their condition, potentially leading to improved outcomes in their daily lives.

What evidence suggests that the High-Intensity Parent Intervention Program is effective for improving learning and school functioning in Latino children with acute leukemia or lymphoblastic lymphoma?

Research shows that programs with active parental involvement can enhance children's learning and school performance. In this trial, parents or caregivers will join one of two programs. Arm II features the High-Intensity Parent Intervention Program (HIP), where parents attend individual skill training sessions with a bilingual therapist. A study of a similar program found that participating parents achieved better results than those who did not. When parents or caregivers learn specific skills, it can positively impact their children's school success. For Latino children with acute leukemia or lymphoblastic lymphoma, this approach may help them overcome educational challenges during treatment. These programs aim to equip parents with effective strategies to support their children's learning. ^{1 2 6 7 8}

Who Is on the Research Team?

Sunita Patel

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for Latino children aged 5-12 who have been treated for acute leukemia or lymphoblastic lymphoma, and their parents/caregivers. The caregivers must be the primary ones, in daily contact with the child, self-identify as Hispanic/Latino, and speak Spanish. Children should understand English and be enrolled in school. Those with severe neurodevelopmental disorders or involved in similar studies are excluded.

Inclusion Criteria

CHILD: Child understands English and is enrolled in school (but can be bilingual)

My child, aged 5-12, is being treated for acute leukemia or other intensive leukemia treatments.

My child finished cancer treatment and it's been up to 10 years since.

Exclusion Criteria

My family or I have a history of major psychiatric conditions or severe neurodevelopmental disorders.

Recent or current participation in educational/behavioral intervention study with similar focus

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Parents or caregivers attend either a high-intensity intervention program (HIP) or a standard of care lower intensity intervention program (LIP). HIP involves individual parental skill training sessions every 2 weeks for a total of 8 sessions, while LIP consists of a single session to review neurocognitive evaluation results.

16 weeks

8 visits (in-person) for HIP, 1 visit (in-person) for LIP

Follow-up

Participants are monitored for learning and school functioning outcomes, as well as parental efficacy and pro-learning behaviors, up to 12 months post enrollment.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• High-Intensity Parent Intervention Program

Trial Overview The study tests a high-intensity parenting program aimed at improving learning and school functioning in Latino children post-leukemia treatment. It compares this intensive training for parents on 'pro-learning' behaviors to a standard lower intensity intervention to see which yields better educational outcomes.

How Is the Trial Designed?

Group I: Arm II (HIP) Experimental Treatment 3 Interventions

Parents or caregivers attend HIP consisting of individual parental skill training sessions with a bilingual therapist over 60-90 minutes every 2 weeks for a total of 8 sessions.

Group II: Arm I (standard of care LIP) Active Control 3 Interventions

Parents or caregivers attend standard of care LIP consisting of a meeting to review results of a neurocognitive evaluation and to discuss recommendations for optimal learning and school performance for 1 session.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03178617

NCT03178617 | High-Intensity Parent Intervention Program ... This randomized clinical trial studies how well a high-intensity intervention parenting program works in improving learning and school functioning in Latino ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40163224/

Effectiveness of a family-management program for ... The FMP was effective in fostering improved outcomes among enrolled parents that received the FMP compared to parents in the control group.

3. withpower.com withpower.com/trial/phase-lymphoma-non-hodgkin-1-2018-7222b

Parenting Intervention Program for Acute Leukemia and ... Trial Overview The study tests a high-intensity parenting program aimed at improving learning and school functioning in Latino children post-leukemia treatment.

4. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT03178617?keyword=%22Acute%22

San Mateo Clinical Trial High-Intensity Parent Intervention ... High-Intensity Parent Intervention Program in Improving Learning and School Functioning in Latino Children With Acute Leukemia or Lymphoblastic Lymphoma.

5. patlynk.com patlynk.com/fr/trial/NCT03178617

High-Intensity Parent Intervention Program in Improving ... This randomized clinical trial studies how well a high-intensity intervention parenting program works in improving learning and school functioning in Latino ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8359930/

The effect of exercise and motor interventions on physical ... Pediatric oncology research supports that exercise is safe, feasible and does not negatively impact a child's ability to complete chemotherapy. Research also ...

7. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/347800

A High Intensity Electronic Health Intervention for the Reduction ... This clinical trial evaluates a high intensity electronic health (eHealth) intervention program for reducing learning disparities in children with cancer.

8. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.e22001

Efficacy and safety of outpatient based therapy in ... Results: Mean age was 7.7±4.89 years old in 125 patients (Table). The 5- and 10-year and 20-year Event Free Survival (EFS) rates were 90.2% ( ...