Telehealth therapy for parents of children with cancer
Feasibility, Acceptability, and Preliminary Efficacy of an Internet-based Parent-child Interaction Therapy (I-PCIT) Intervention for Children With Cancer
This study is testing whether online therapy can help parents of young children with cancer improve their parenting skills and emotional well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Sex | All |
| Sponsor | Johns Hopkins All Children's Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (St. Petersburg, Florida) |
| Trial ID | NCT06346782 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility and acceptability of Internet-Based Parent-Child Interaction Therapy (I-PCIT) for parents of children aged 2-12 who are currently undergoing or have previously undergone cancer treatment. Parents will complete an initial survey to determine eligibility, and those who qualify will be randomly assigned to receive the I-PCIT intervention immediately or to a waitlist for 5-6 months. The intervention consists of 13 weekly sessions conducted via telehealth, with follow-up surveys to assess outcomes. Special accommodations will be made for Spanish-speaking families to ensure accessibility.
Who should consider this trial
Good fit: Ideal candidates are parents of children aged 2-12 who have received or are receiving cancer treatment involving chemotherapy or radiation.
Not a fit: Patients who have cognitive, motor, or language delays that prevent participation in the therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve behavioral outcomes for children recovering from cancer treatment.
How similar studies have performed: Other studies have shown promise with telehealth interventions for behavioral issues, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants will be parents of 2-12 year-old children who (1) currently or previously received cancer treatment and/or long-term cancer follow-up care at Johns Hopkins All Children's Hospital (JHACH). * The child's cancer treatment must have included or plan to include chemotherapy and/or radiation. * The child's cancer diagnosis must have been conferred at least 6 weeks prior to study enrollment. If a patient's cancer relapses during the study period, the patient's oncologist must agree to the patient continuing in this intervention. * The parent must have access to reliable internet service (e.g., in their own home, in a friend or family member's home, via cell phone carrier) and their own smartphone, tablet, or computer to participate in telehealth intervention sessions. Exclusion Criteria: * Parents will be excluded if they or their child have cognitive, motor, or language delays that would preclude participation, as observed by research staff or listed in the child's medical record. Hearing impaired parents will also be excluded because I-PCIT requires the coach to verbally coach parents via bug-in-ear. * Parents will be excluded if their child is expected to undergo bone marrow transplant (BMT) during the study or has received BMT within 2 months of study enrollment. * The child must not be receiving end of life care, as determined by medical chart review and/or consultation with the patient's medical team.
Where this trial is running
St. Petersburg, Florida
- Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Melissa Faith, Ph.D. — Johns Hopkins All Children's Hospital
- Study coordinator: Melissa Faith, Ph.D.
- Email: mfaith1@jhmi.edu
- Phone: 7272958477
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.