Parenting Intervention Program for Acute Leukemia and Lymphoblastic Lymphoma

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

214 Participants Needed

Trial Summary

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 data supports the effectiveness of the High-Intensity Parent Intervention Program treatment for acute leukemia and lymphoblastic lymphoma?

Research shows that parenting interventions can help improve child behavior and family coping in cases of childhood leukemia. Studies have found that such programs can lead to better compliance with treatment and reduce stress in parents, which may indirectly benefit children undergoing treatment for leukemia. ^{1 2 3 4 5}

Is the Parenting Intervention Program for Acute Leukemia and Lymphoblastic Lymphoma safe for participants?

The available studies on parenting interventions for families dealing with childhood leukemia suggest that these programs are generally safe and well-received, with positive outcomes in coping and reduced distress for both parents and children. ^{1 2 3 5 6}

How does the Parenting Intervention Program for Acute Leukemia and Lymphoblastic Lymphoma differ from other treatments?

The Parenting Intervention Program is unique because it focuses on helping parents manage the emotional and behavioral challenges their children face during leukemia treatment, rather than directly treating the disease itself. This program includes group videoconferencing and structured support groups to improve coping skills and reduce psychological distress, which is not typically addressed by standard medical treatments for leukemia. ^{1 2 7 8 9}

What is the purpose of this trial?

This randomized clinical trial studies how well a high-intensity intervention parenting program works in improving learning and school functioning in Latino children with acute leukemia or lymphoblastic lymphoma. A high-intensity intervention program may help doctors to see whether training parents or caregivers in specific parenting skills and "pro-learning" behaviors will result in better learning and school outcomes for Latino children with acute leukemia or lymphoblastic lymphoma. It is not yet known if a high-intensity intervention program is more beneficial than a standard of care lower intensity parenting intervention.

Research Team

Sunita Patel

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Scotland pubmed.ncbi.nlm.nih.gov

Addressing behavioral impacts of childhood leukemia: A feasibility pilot randomized controlled trial of a group videoconferencing parenting intervention. [2018]

2. Singapore pubmed.ncbi.nlm.nih.gov

Childhood leukaemia: towards an integrated psychosocial intervention programme in Singapore. [2020]

3. Egypt pubmed.ncbi.nlm.nih.gov

A systematic review of randomized controlled interventions for parents' distress in pediatric leukemia. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

The importance of parenting concerns among patients with cancer. [2022]

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

Adaptation of an Intervention to Reduce Disparities in School HRQOL for Latino Childhood Cancer Survivors. [2021]

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

A randomized controlled prospective outcome study of a psychological and pharmacological intervention protocol for procedural distress in pediatric leukemia. [2019]

7. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Psychiatric morbidity in Egyptian children with acute lymphoblastic leukemia and their care providers. [2015]

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

Gaps in Parental Understanding of Sleep Disturbances During Maintenance Therapy for Pediatric Acute Lymphoblastic Leukemia. [2023]

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

Psychological distress in parents of children with acute lymphatic leukemia. [2019]