Pediatric CancerI-PCITNCT06346782
Feasibility and Acceptability of Internet-based Parent-child Interaction Therapy (I-PCIT) in Pediatric Cancer
A study testing Internet-Based Parent-Child Interaction Therapy in people with Pediatric Cancer and Oncology, run by Johns Hopkins All Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pediatric Cancer, Oncology, Disruptive Behavior
- What is being tested?
- Internet-Based Parent-Child Interaction Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2024to 1 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
Melissa Faith, Ph.D., 727-295-8477, mfaith1@jhmi.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Pediatric Cancer, Oncology, Disruptive Behavior
- Being tested
- Internet-Based Parent-Child Interaction Therapy
- Keywords
- Pediatric Cancer, Oncology, Parent, Parenting, Disruptive Behavior
- Medical subject headings
- Neoplasms, Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-Based Parent-Child Interaction TherapyBehavioural
Also called I-PCIT
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.
| Study group | Role | What they receive |
|---|---|---|
| I-PCIT | Experimental | 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. Receives: Behavioral: Internet-Based Parent-Child Interaction Therapy |
| Waitlist Control | Active comparator | 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. Receives: Behavioral: Internet-Based Parent-Child Interaction Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
I-PCIT Feasibility as assessed by intervention completion
Investigators will determine I-PCIT was feasible if at least 65% of parents in the I-PCIT arm reach minimum benchmark for PCIT completion.
Measured: 37 weeks
I-PCIT Acceptability as assessed by the Treatment Evaluation Inventory Short form
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.
Measured: 37 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start19 Feb 2024
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a pilot feasibility trial. We are using a 2:1 (intervention: waitlist control) randomized controlled design.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins All Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa Faith, Ph.D., Principal investigator, Johns Hopkins All Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346782
- Sponsor's protocol ID
- IRB00370545
- Acronym
- I-PCIT
- Status last verified
- Apr 2026
- First submitted
- 19 Feb 2024
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified data will be available on request with principal investigator approval
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability, and Preliminary Efficacy of an Internet-based Parent-child Interaction Therapy (I-PCIT) Intervention for Children With Cancer
- ClinicalTrials.gov ID
- NCT06346782
- Acronym / sponsor ID
- I-PCIT / IRB00370545
- Conditions
- Pediatric Cancer, Oncology, Disruptive Behavior
- Keywords
- Pediatric Cancer, Oncology, Parent, Parenting, Disruptive Behavior
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Johns Hopkins All Children's HospitalUniversity, hospital or other
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a pilot feasibility trial. We are using a 2:1 (intervention: waitlist control) randomized controlled design.
| Arm | Type | Receives |
|---|---|---|
| I-PCIT | Experimental | Behavioral: Internet-Based Parent-Child Interaction TherapyParticipants 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. |
| Waitlist Control | Active comparator | Behavioral: Internet-Based Parent-Child Interaction TherapyParticipants 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 may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-Based Parent-Child Interaction TherapyAlso: I-PCITI-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. | Behavioural | I-PCIT, Waitlist Control |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No. De-identified data will be available on request with principal investigator approval
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melissa Faith, Ph.D. principal investigator
Johns Hopkins All Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-Based Parent-Child Interaction Therapy in people with Pediatric Cancer and Oncology, run by Johns Hopkins All Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melissa Faith, Ph.D. (7272958477, mfaith1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
I-PCIT Feasibility as assessed by intervention completion (time frame: 37 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.