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

March 29, 2024 updated by: Johns Hopkins All Children's Hospital

Feasibility, Acceptability, and Preliminary Efficacy of an Internet-based Parent-child Interaction Therapy (I-PCIT) Intervention for Children With Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Saint Petersburg, Florida, United States, 33701
        • Recruiting
        • Johns Hopkins All Children's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: 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.
Other Names:
  • I-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.
Behavioral: 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.
Other Names:
  • I-PCIT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
I-PCIT Feasibility as assessed by intervention completion
Time Frame: 37 weeks
Investigators will determine I-PCIT was feasible if at least 65% of parents in the I-PCIT arm reach minimum benchmark for PCIT completion.
37 weeks
I-PCIT Acceptability as assessed by the Treatment Evaluation Inventory Short form
Time Frame: 37 weeks
Investigators will consider I-PCIT acceptable if at least 80% of parents demonstrate scores of at least 27 on the Treatment Evaluation Inventory-Short Form. Scale range is 9 to 45. Higher scores correspond to greater acceptability of the intervention.
37 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins All Children's Hospital

Investigators

  • Principal Investigator: Melissa Faith, Ph.D., Johns Hopkins All Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2024

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

February 19, 2024

First Submitted That Met QC Criteria

March 29, 2024

First Posted (Actual)

April 4, 2024

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00370545

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

De-identified data will be available on request with principal investigator approval

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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