Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06346782
Status:
RECRUITING
Last Update Posted:
2024-04-04
First Post:
2024-02-19
Brief Title:
Feasibility and Acceptability of Internet-based Parent-child Interaction Therapy I-PCIT in Pediatric Cancer
Sponsor:
Johns Hopkins All Childrens Hospital
Organization:
Johns Hopkins All Childrens Hospital
Study Overview
Official Title:
Feasibility Acceptability and Preliminary Efficacy of an Internet-based Parent-child Interaction Therapy I-PCIT Intervention for Children With Cancer
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
I-PCIT
Brief 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 childs 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
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 childs 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 childs 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 childs 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
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 childs 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 childs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None