Feasibility and Acceptability of Internet-based Parent-child Interaction Therapy (I-PCIT) in Pediatric Cancer

Last updated: April 9, 2025
Sponsor: Johns Hopkins All Children's Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neuroblastoma

Cancer

Neoplasms

Treatment

Internet-Based Parent-Child Interaction Therapy

Clinical Study ID

NCT06346782
IRB00370545
  • All Genders

Study Summary

This study is being done to learn whether a telehealth intervention called "Internet-Based Parent Child Interaction Therapy," or I-PCIT," can help parents improve the child's behavior if the child currently or previously went through cancer treatment.

Parents who choose to be in this study will complete a survey to help researchers figure out if the parent is eligible for the larger study. If a parent is eligible for the larger study and chooses to participate, if so, the participants will be randomly assigned to either receive the I-PCIT intervention now or to be on a waitlist and begin I-PCIT in 5-6 months. The whole study consists of completing I-PCIT sessions with a clinician and completing 3-4 follow-up surveys after the initial screener survey.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants will be parents of 2-12 year-old children who (1) currently orpreviously received cancer treatment and/or long-term cancer follow-up care at JohnsHopkins All Children's Hospital (JHACH).

  • The child's cancer treatment must have included or plan to include chemotherapyand/or radiation.

  • The child's cancer diagnosis must have been conferred at least 6 weeks prior tostudy enrollment. If a patient's cancer relapses during the study period, thepatient'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 ownsmartphone, tablet, or computer to participate in telehealth intervention sessions.

Exclusion

Exclusion Criteria:

  • Parents will be excluded if they or their child have cognitive, motor, or languagedelays that would preclude participation, as observed by research staff or listed inthe child's medical record. Hearing impaired parents will also be excluded becauseI-PCIT requires the coach to verbally coach parents via bug-in-ear.

  • Parents will be excluded if their child is expected to undergo bone marrowtransplant (BMT) during the study or has received BMT within 2 months of studyenrollment.

  • The child must not be receiving end of life care, as determined by medical chartreview and/or consultation with the patient's medical team.

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Internet-Based Parent-Child Interaction Therapy
Phase:
Study Start date:
February 19, 2024
Estimated Completion Date:
August 01, 2028

Study Description

This study is being done to learn whether a telehealth intervention called "Internet-Based Parent Child Interaction Therapy," or I-PCIT," can help parents improve the child's behavior if the child currently or previously went through cancer treatment.

Parents who choose to be in this study will complete a survey to help researchers figure out if the parent is eligible for the larger study. If a parent is eligible for the larger study and chooses to participate, the investigators will randomly assign the participants to either receive the I-PCIT intervention now or to be on a waitlist and begin I-PCIT in 5-6 months. The whole study consists of completing I-PCIT sessions with a clinician and completing 3-4 follow-up surveys after the initial screener survey.

I-PCIT is language-dependent. The investigators will make every effort to recruit a Spanish-speaking fellow clinician for this study. However, if unable to recruit a Spanish-speaking fellow, a licensed clinical social worker and certified Spanish interpreter, will provide I-PCIT services to Spanish-speaking families. Children may participate even if the child cannot produce spoken language. Participants may request that research personnel read all assessment materials aloud in a structured interview format, in which case participants could provide verbal item responses. Because of this option, participants' ability to read and write are not requirements for participation.

The I-PCIT intervention will consist of 13 weekly telehealth sessions with a clinician who is certified in PCIT. The first telehealth session will take about 60-75 minutes. The rest of the telehealth sessions will take about 40-60 minutes. I-PCIT teaches parents how to build more positive interactions with the child and how to improve management of the child's behavior challenges.

Parents who receive I-PCIT in this study will not be charged for any I-PCIT services. Parents who are assigned to the waitlist until I-PCIT begins and may continue receiving any other services to help manage the child's behavior while waiting to start I-PCIT.

The study will last about 5-5 ½ months for parents who are assigned to start I-PCIT right away. For parents who are assigned to the waitlist to start I-PCIT in 5-6 months, parents will complete the study, including I-PCIT sessions, in about 8-9 months.

In addition to the initial survey to see if parents are eligible for I-PCIT, parents who are assigned to I-PCIT or the waitlist will also be asked to complete follow-up surveys 3-4 times during the study.

Connect with a study center

  • Johns Hopkins All Children's Hospital

    Saint Petersburg, Florida 33701
    United States

    Active - Recruiting

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