Internet-Based Parent-Child Interaction Therapy for Pediatric Cancer

(I-PCIT Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Melissa Faith, Ph.D.

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Johns Hopkins All Children's Hospital

Disqualifiers: Cognitive delays, Motor delays, Language delays, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Internet-Based Parent-Child Interaction Therapy (I-PCIT) for pediatric cancer?

Research shows that Parent-Child Interaction Therapy (PCIT) is effective for treating behavior problems in children, including those with disruptive behavior and conduct issues. A case report suggests that Internet-based PCIT (I-PCIT) can be beneficial for medically ill children, indicating its potential usefulness in pediatric cancer cases.

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Is Internet-Based Parent-Child Interaction Therapy (I-PCIT) safe for use in humans?

Parent-Child Interaction Therapy (PCIT), including its internet-based version (I-PCIT), has been used safely for treating behavior problems in children, including those with medical conditions and autism. There is no specific mention of safety concerns in the available research, suggesting it is generally considered safe.

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How is Internet-Based Parent-Child Interaction Therapy (I-PCIT) different from other treatments for pediatric cancer?

Internet-Based Parent-Child Interaction Therapy (I-PCIT) is unique because it is conducted online, allowing therapy to take place in the comfort of the child's home, which can be especially beneficial for children with cancer who may have compromised immune systems or difficulty traveling. This approach also enhances the ecological validity (real-world applicability) of the therapy by integrating it into the child's everyday environment.

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Eligibility Criteria

This trial is for parents of children who are currently undergoing or have previously undergone cancer treatment and are experiencing disruptive behaviors. Parents must be willing to complete surveys and participate in telehealth therapy sessions.

Inclusion Criteria

The parent must have access to reliable internet service and their own smartphone, tablet, or computer to participate in telehealth intervention sessions

My child was diagnosed with cancer more than 6 weeks ago.

My child's cancer treatment includes or will include chemotherapy or radiation.

Exclusion Criteria

My child is receiving care focused on comfort in their final days.

My parents are hearing impaired.

Parents with children who have cognitive, motor, or language delays that would preclude participation

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (virtual)

Treatment

Participants receive 13 weekly telehealth I-PCIT sessions with a clinician

13 weeks

13 visits (virtual)

Follow-up

Participants complete 3-4 follow-up surveys to assess the intervention's feasibility and acceptability

24 weeks

3-4 visits (virtual)

Participant Groups

The study tests 'Internet-Based Parent-Child Interaction Therapy' (I-PCIT) to see if it can help improve the behavior of children with a history of cancer. Participants will either start I-PCIT immediately or after a waitlist period, determined randomly.

Group I: I-PCIT Experimental Treatment 1 Intervention

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.

Group II: Waitlist Control Active Control 1 Intervention

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Johns Hopkins All Children's Hospital Saint Petersburg, FL

Who Is Running the Clinical Trial?

Johns Hopkins All Children's Hospital Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Direct-to-Consumer Marketing for Parent-Child Interaction Therapy: Impact of Language and Messenger. [2022] Parent-Child Interaction Therapy (PCIT) is an effective therapy to treat early onset disruptive behavior problems and child physical maltreatment. In order to support the successful implementation and sustainment of PCIT, strategies are needed to recruit parents into care, especially for racial and ethnic minority families, who often have lower rates of access and utilization of mental health services.

2. Switzerland pubmed.ncbi.nlm.nih.gov

Barriers to Clinician Implementation of Parent-Child Interaction Therapy (PCIT) in New Zealand and Australia: What Role for Time-Out? [2021] Parent-Child Interaction Therapy (PCIT) is an effective parent training approach for a commonly occurring and disabling condition, namely conduct problems in young children. Yet, despite ongoing efforts to train clinicians in PCIT, the intervention is not widely available in New Zealand and Australia.

3. United States pubmed.ncbi.nlm.nih.gov

Using an online viewing system for Parent-Child Interaction therapy consulting with professionals. [2012] Parent-Child Interaction Therapy (PCIT) training was provided to therapists working with parents of children with disruptive behavior problems. Therapists uploaded video-recordings of selected sessions using a web-based tool for video sharing and review, the Video Analysis Tool (VAT). Trainers utilized the VAT for consultation to improve treatment fidelity. Clinical practice benefits include the ability to provide targeted, specific feedback to the trainees soon after a session and to disseminate PCIT to a larger, global audience.

4. United States pubmed.ncbi.nlm.nih.gov

Internet parent-child interaction therapy (I-PCIT) in medically ill child: A case report. [2023] This case illustrates the feasibility, benefit, and putative enhanced ecological validity of performing internet-parent-child interaction therapy (I-PCIT) in the parent-child dyad's home for the treatment of behavior problems in medically ill children in the context of a global pandemic.

5. Spain pubmed.ncbi.nlm.nih.gov

Meta-analysis of the Efficacy and Effectiveness of Parent Child Interaction Therapy (PCIT) for Child Behaviour Problems. [2021] Parent-Child Interaction Therapy (PCIT) is a well-established treatment for behavioural, hyperactivity and oppositional-defiant problems in children. Previous meta-analyses are scarce, and they have tended to mix problems and measures.

6. United States pubmed.ncbi.nlm.nih.gov

Tele-PCIT: Initial Examination of Internet Delivered PCIT for Young Children with Autism. [2023] Parent-Child Interaction Therapy (PCIT) is an empirically supported behavioral parenting program for disruptive behavior and has been shown to also be effective for children with autism spectrum disorder (ASD). Telehealth delivery of PCIT (Tele-PCIT) is also supported, but no trials have focused on children with ASD. The purpose of the study was to examine the initial efficacy of a time limited version of Tele-PCIT within an ASD sample.