Clinical trial NCT06346782: Feasibility and Acceptability of Internet-based Parent-child Interaction Therapy (I-PCIT) in Pediatric Cancer
Official title: Feasibility, Acceptability, and Preliminary Efficacy of an Internet-based Parent-child Interaction Therapy (I-PCIT) Intervention for Children With Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Cancer
Oncology
Disruptive Behavior
Keywords: Pediatric Cancer
Oncology
Parent
Parenting
Disruptive Behavior
Lead sponsor: Johns Hopkins All Children's Hospital
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a pilot feasibility trial. We are using a 2:1 (intervention: waitlist control) randomized controlled design.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: I-PCIT Feasibility as assessed by intervention completion
timeFrame: 37 weeks
measure: I-PCIT Acceptability as assessed by the Treatment Evaluation Inventory Short form
timeFrame: 37 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
facility: Johns Hopkins All Children's Hospital
state: Florida
Study officials:
affiliation: Johns Hopkins All Children's Hospital
name: Melissa Faith, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: