Recruiting

I-PCIT

Sponsor:

Johns Hopkins All Children's Hospital

Code:

NCT06346782

Conditions

Pediatric Cancer

Oncology

Disruptive Behavior

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Internet-Based Parent-Child Interaction Therapy

Study Details

Brief 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.

Conditions

Pediatric Cancer

Oncology

Disruptive Behavior

Study ID

NCT06346782

Start date

Feb 19, 2024

Status verified date

Apr, 2026

Completion date

Aug 1, 2028

Anticipated

Primary completion date

Aug 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: I-PCIT

Participants in this study arm will receive an initial intake session with a cultural formulation interview (based on the Diagnostic and Statistical Manual (DSM-V), then will receive time-limited internet-based PCIT.

active comparator: Waitlist Control

Participants in this study arm will begin the I-PCIT intervention after a waitlist of 5-6 months. The I-PCIT intervention will be parallel to that in the I-PCIT arm.

Interventions

Internet-Based Parent-Child Interaction Therapy

I-PCIT consists of two phases. The first phase is designed to enhance positive parent-child interactions. The second phase is designed to enhance parents' behavior management parenting behaviors.

Primary outcome measure

  • I-PCIT Feasibility as assessed by intervention completion [ Time Frame: 37 weeks ]
  • I-PCIT Acceptability as assessed by the Treatment Evaluation Inventory Short form [ Time Frame: 37 weeks ]

Central Contacts and Locations

Central contacts

Melissa Faith, Ph.D.

7272958477mfaith1@jhmi.edu

Locations

Johns Hopkins All Children's Hospital

Recruiting

St. Petersburg, Florida, United States, 33701

Contacts

Melissa Faith, Ph.D.

727-295-8477mfaith1@jhmi.edu

More Information

Sponsor

Johns Hopkins All Children's Hospital

Last update posted

Apr 30, 2026

Last verified

Apr, 2026

Keywords

  • Pediatric Cancer
  • Oncology
  • Parent
  • Parenting
  • Disruptive Behavior

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins All Children's Hospital on 2026-04-30.