Internet-Based Parent-Child Interaction Therapy for Pediatric Cancer

(I-PCIT Trial)

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

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. ^{1 2 3 4 5}

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. ^{1 2 4 5 6}

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. ^{1 2 3 4 5}

Research Team

Melissa Faith, Ph.D.

Principal Investigator

Johns Hopkins All Children's Hospital

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

References

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

Direct-to-Consumer Marketing for Parent-Child Interaction Therapy: Impact of Language and Messenger. [2022]

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]

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

Using an online viewing system for Parent-Child Interaction therapy consulting with professionals. [2012]

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

Internet parent-child interaction therapy (I-PCIT) in medically ill child: A case report. [2023]

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]

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

Tele-PCIT: Initial Examination of Internet Delivered PCIT for Young Children with Autism. [2023]