Internet-Based Parent-Child Interaction Therapy for Pediatric Cancer

(I-PCIT Trial)

Recruiting at 1 trial location

Overseen By Melissa Faith, Ph.D.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins All Children's Hospital

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 17

Duration: 13 weeks

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if a telehealth program called Internet-Based Parent-Child Interaction Therapy (I-PCIT) can help parents improve their children's behavior during or after cancer treatment. The study divides participants into two groups: one receives the treatment immediately, while the other begins after a 5-6 month wait. Parents of children aged 2-12 who have undergone chemotherapy or radiation and have internet access are suitable candidates for the trial. As an unphased trial, this study provides a unique opportunity for parents to access potentially beneficial therapy without the constraints of traditional clinical trial phases.

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 prior data suggests that Internet-Based Parent-Child Interaction Therapy is safe?

Research shows that Internet-Based Parent-Child Interaction Therapy (I-PCIT) is safe. Studies have found that this therapy can reduce disruptive behaviors in children and boost caregivers' confidence. Both children and parents generally handle the treatment well. During the COVID-19 pandemic, therapists reported positive experiences using I-PCIT, further supporting its safety and effectiveness. No major reports of negative side effects have emerged, making it a promising option for families dealing with pediatric cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Internet-Based Parent-Child Interaction Therapy (I-PCIT) for pediatric cancer because it offers a novel approach to improving mental health support for children and their families. Unlike traditional in-person therapy sessions, I-PCIT is delivered online, making it accessible to families regardless of their location, which is particularly beneficial for those dealing with the logistical challenges of cancer treatment. This internet-based approach allows for flexibility and convenience, helping parents and children maintain consistent therapeutic engagement without the need for travel. Moreover, the inclusion of a cultural formulation interview ensures that the therapy is tailored to the unique cultural backgrounds of participants, enhancing its relevance and effectiveness.

What evidence suggests that Internet-Based Parent-Child Interaction Therapy is effective for improving child behavior after cancer treatment?

Research has shown that Internet-Based Parent-Child Interaction Therapy (I-PCIT), which participants in this trial may receive, can improve children's behavior, particularly in challenging situations like dealing with cancer. In some studies, about 35.8% of caregivers reported significant improvement in their child's behavior after using I-PCIT. This therapy is conducted online, providing families with an easy and convenient option. I-PCIT aims to strengthen the bond between parents and children, which is crucial when managing stress and behavior issues. Early findings suggest that this method is both practical and beneficial for families facing pediatric cancer. ^{1 4 5 6 7}

Who Is on the Research Team?

Melissa Faith, Ph.D.

Principal Investigator

Johns Hopkins All Children's Hospital

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Internet-Based Parent-Child Interaction Therapy

Trial Overview 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.

How Is the Trial Designed?

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.

Who Is Running the Clinical Trial?

Johns Hopkins All Children's Hospital

Lead Sponsor

Trials

47

Recruited

5,009,000+

Published Research Related to This Trial

Parent-Child Interaction Therapy (PCIT) training for therapists effectively utilized a web-based Video Analysis Tool (VAT) to enhance treatment fidelity by allowing trainers to provide immediate, targeted feedback on recorded therapy sessions.

This innovative approach not only improves the quality of therapy for children with disruptive behavior problems but also enables broader dissemination of PCIT techniques to a global audience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using an online viewing system for Parent-Child Interaction therapy consulting with professionals. Wilsie, CC., Brestan-Knight, E.[2012]

Internet-parent-child interaction therapy (I-PCIT) conducted at home significantly improved disruptive behaviors in a 5-year-old girl with attention deficit hyperactivity disorder and other medical issues, demonstrating its feasibility and effectiveness during a global pandemic.

The combination of I-PCIT and medication (methylphenidate) helped the child succeed both at home and in school, suggesting that integrated treatment approaches may be beneficial for medically ill children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet parent-child interaction therapy (I-PCIT) in medically ill child: A case report. Melo, V., Zaccariello, M., Girard, E., et al.[2023]

Parent-Child Interaction Therapy (PCIT) is viewed as an effective treatment for conduct problems in young children, but its implementation is limited in New Zealand and Australia due to barriers such as lack of access to necessary equipment and client attendance issues.

Clinicians generally feel less confident in the Parent-Directed Interaction phase, which includes time-out strategies, but concerns about time-out were not the main barrier to implementation; instead, adapting the protocol to include more emotion regulation content was common among those who tailor the therapy.

NCBI (Pubmed)

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? Woodfield, MJ., Cargo, T., Merry, SN., et al.[2021]

In a study involving 20 children aged 2-6 with autism spectrum disorder (ASD), Telehealth delivery of Parent-Child Interaction Therapy (Tele-PCIT) showed significant improvements in both parenting practices and child behavior after 10 sessions, with 80% of participants completing the treatment.

Parents reported reduced stress and negative parenting behaviors, alongside increased use of positive parenting skills, while children exhibited decreased externalizing behavior problems, with these benefits maintained at a 3-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tele-PCIT: Initial Examination of Internet Delivered PCIT for Young Children with Autism. Ros-DeMarize, R., Boan, A., Bradley, C., et al.[2023]

Direct-to-consumer advertisements for Parent-Child Interaction Therapy (PCIT) can effectively influence Spanish-speaking parents' intentions to seek help, especially when the messenger is a therapist rather than a parent.

The study highlights the importance of tailored advertising strategies to improve access to mental health services for racial and ethnic minority families, as Spanish-speaking participants showed varying help-seeking intentions based on the messenger used in the advertisements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Direct-to-Consumer Marketing for Parent-Child Interaction Therapy: Impact of Language and Messenger. Barnett, ML., Bernal, NA., Luis Sanchez, BE.[2022]

Parent-Child Interaction Therapy (PCIT) is highly effective for treating behavioral problems in children aged 2 to 12, showing a significant mean effect size of -0.87 compared to control groups based on a meta-analysis of 100 studies from 1980 to 2020.

While PCIT demonstrates strong initial effectiveness, the benefits appear to diminish over time, as indicated by a smaller and non-significant effect size of -0.23 during follow-up assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis of the Efficacy and Effectiveness of Parent Child Interaction Therapy (PCIT) for Child Behaviour Problems. Valero-Aguayo, L., Rodríguez-Bocanegra, M., Ferro-García, R., et al.[2021]

Citations

1. trialx.com trialx.com/clinical-trials/listings/287559/feasibility-and-acceptability-of-internet-based-parent-child-interaction-therapy-i-pcit-in-pediatric-cancer/

Feasibility and Acceptability of Internet-based Parent-child ... This study is being done to learn whether a telehealth intervention called "Internet-Based Parent Child Interaction Therapy," or I-PCIT," can ...

2. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/475575

Feasibility and Acceptability of Internet-based Parent-child ... This study is being done to learn whether a telehealth intervention called "Internet-Based Parent Child Interaction Therapy," or I-PCIT," can help parents ...

3. journals.lww.com journals.lww.com/md-journal/fulltext/2021/10150/internet_parent_child_interaction_therapy__i_pcit_.57.aspx

Internet parent–child interaction therapy (I-PCIT) in... This case illustrates the feasibility, benefit, and putative enhanced ecological validity of performing internet-parent–child interaction therapy (I-PCIT)

4. jmir.org jmir.org/2025/1/e69887

Pocket Parent-Child Interaction Therapy (PCIT) Online for ... Of note, approximately 35.8% (73/204) of caregivers reported clinically significant improvements in their children's frequency of disruptive ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06346782/feasibility-and-acceptability-of-internet-based-parent-child-interaction-therapy-i-pcit-in-pediatric-cancer

Feasibility and Acceptability of Internet-based Parent-child ... This study is being done to learn whether a telehealth intervention called "Internet-Based Parent Child Interaction Therapy," or I-PCIT," ...

6. tandfonline.com tandfonline.com/doi/full/10.1080/07317107.2025.2540794?src=exp-la

Parent–Child Interaction Therapy with a Pediatric Acute ... Parent–Child Interaction Therapy (PCIT) can reduce children's disruptive behaviors and improve caregiver self-efficacy.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8112899/

Therapist Experiences and Attitudes About Implementing ... This mixed methods study conducted a follow-up survey to gather therapist experiences (N = 223) in delivering iPCIT during COVID-19.