{
    "info": {
        "nct_id": "NCT06346782",
        "official_title": "Feasibility, Acceptability, and Preliminary Efficacy of an Internet-based Parent-child Interaction Therapy (I-PCIT) Intervention for Children With Cancer",
        "inclusion_criteria": "* 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).\n* The child's cancer treatment must have included or plan to include chemotherapy and/or radiation.\n* 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.\n* 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.\nHealthy volunteers allowed",
        "exclusion_criteria": "* 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.\n* 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.\n* 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.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* 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).",
                "criterions": [
                    {
                        "exact_snippets": "Participants will be parents",
                        "criterion": "participant role",
                        "requirement": {
                            "requirement_type": "role",
                            "expected_value": "parent"
                        }
                    },
                    {
                        "exact_snippets": "2-12 year-old children",
                        "criterion": "child age",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "year"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 12,
                                        "unit": "year"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "currently or previously received cancer treatment",
                        "criterion": "child cancer treatment",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": [
                                "current",
                                "previous"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "long-term cancer follow-up care",
                        "criterion": "child cancer follow-up care",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "long-term"
                        }
                    },
                    {
                        "exact_snippets": "Johns Hopkins All Children's Hospital (JHACH)",
                        "criterion": "treatment location",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "Johns Hopkins All Children's Hospital (JHACH)"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Participants will be parents",
                                "criterion": "participant role",
                                "requirement": {
                                    "requirement_type": "role",
                                    "expected_value": "parent"
                                }
                            },
                            {
                                "exact_snippets": "2-12 year-old children",
                                "criterion": "child age",
                                "requirement": {
                                    "requirement_type": "range",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": ">=",
                                                "value": 2,
                                                "unit": "year"
                                            },
                                            {
                                                "operator": "<=",
                                                "value": 12,
                                                "unit": "year"
                                            }
                                        ]
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "currently or previously received cancer treatment",
                                        "criterion": "child cancer treatment",
                                        "requirement": {
                                            "requirement_type": "status",
                                            "expected_value": [
                                                "current",
                                                "previous"
                                            ]
                                        }
                                    },
                                    {
                                        "exact_snippets": "Johns Hopkins All Children's Hospital (JHACH)",
                                        "criterion": "treatment location",
                                        "requirement": {
                                            "requirement_type": "location",
                                            "expected_value": "Johns Hopkins All Children's Hospital (JHACH)"
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "long-term cancer follow-up care",
                                        "criterion": "child cancer follow-up care",
                                        "requirement": {
                                            "requirement_type": "status",
                                            "expected_value": "long-term"
                                        }
                                    },
                                    {
                                        "exact_snippets": "Johns Hopkins All Children's Hospital (JHACH)",
                                        "criterion": "treatment location",
                                        "requirement": {
                                            "requirement_type": "location",
                                            "expected_value": "Johns Hopkins All Children's Hospital (JHACH)"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* The child's cancer treatment must have included or plan to include chemotherapy and/or radiation.",
                "criterions": [
                    {
                        "exact_snippets": "The child's cancer treatment must have included or plan to include chemotherapy",
                        "criterion": "chemotherapy",
                        "requirement": {
                            "requirement_type": "inclusion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "The child's cancer treatment must have included or plan to include ... radiation",
                        "criterion": "radiation",
                        "requirement": {
                            "requirement_type": "inclusion",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "The child's cancer treatment must have included or plan to include chemotherapy",
                                "criterion": "chemotherapy",
                                "requirement": {
                                    "requirement_type": "inclusion",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "The child's cancer treatment must have included or plan to include ... radiation",
                                "criterion": "radiation",
                                "requirement": {
                                    "requirement_type": "inclusion",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* 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.",
                "criterions": [
                    {
                        "exact_snippets": "The child's cancer diagnosis must have been conferred at least 6 weeks prior to study enrollment.",
                        "criterion": "cancer diagnosis timing",
                        "requirement": {
                            "requirement_type": "time since diagnosis",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "If a patient's cancer relapses during the study period, the patient's oncologist must agree to the patient continuing in this intervention.",
                        "criterion": "oncologist agreement for continuation",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "If a patient's cancer relapses during the study period, the patient's oncologist must agree to the patient continuing in this intervention.",
                    "criterion": "oncologist agreement for continuation",
                    "requirement": {
                        "requirement_type": "agreement",
                        "expected_value": true
                    }
                },
                "then_criteria": null,
                "else_criteria": {
                    "and_criteria": [
                        {
                            "exact_snippets": "The child's cancer diagnosis must have been conferred at least 6 weeks prior to study enrollment.",
                            "criterion": "cancer diagnosis timing",
                            "requirement": {
                                "requirement_type": "time since diagnosis",
                                "expected_value": {
                                    "operator": ">=",
                                    "value": 6,
                                    "unit": "weeks"
                                }
                            }
                        }
                    ]
                }
            }
        },
        {
            "identified_line": {
                "line": "* 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.",
                "criterions": [
                    {
                        "exact_snippets": "The parent must have access to reliable internet service",
                        "criterion": "internet service access",
                        "requirement": {
                            "requirement_type": "access",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "The parent must have access to reliable internet service",
                        "criterion": "internet service access",
                        "requirement": {
                            "requirement_type": "reliability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "their own smartphone, tablet, or computer",
                        "criterion": "device ownership",
                        "requirement": {
                            "requirement_type": "ownership",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "their own smartphone, tablet, or computer",
                        "criterion": "device ownership",
                        "requirement": {
                            "requirement_type": "device type",
                            "expected_value": [
                                "smartphone",
                                "tablet",
                                "computer"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "The parent must have access to reliable internet service",
                                "criterion": "internet service access",
                                "requirement": {
                                    "requirement_type": "access",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "The parent must have access to reliable internet service",
                                "criterion": "internet service access",
                                "requirement": {
                                    "requirement_type": "reliability",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "their own smartphone, tablet, or computer",
                                "criterion": "device ownership",
                                "requirement": {
                                    "requirement_type": "ownership",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "their own smartphone, tablet, or computer",
                                "criterion": "device ownership",
                                "requirement": {
                                    "requirement_type": "device type",
                                    "expected_value": [
                                        "smartphone",
                                        "tablet",
                                        "computer"
                                    ]
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* 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.",
                "criterions": [
                    {
                        "exact_snippets": "cognitive, motor, or language delays ... as observed by research staff or listed in the child's medical record",
                        "criterion": "cognitive, motor, or language delays",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Hearing impaired parents will also be excluded",
                        "criterion": "hearing impairment",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "cognitive, motor, or language delays ... as observed by research staff or listed in the child's medical record",
                                        "criterion": "cognitive, motor, or language delays",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "cognitive, motor, or language delays ... as observed by research staff or listed in the child's medical record",
                                        "criterion": "cognitive, motor, or language delays",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Hearing impaired parents will also be excluded",
                        "criterion": "hearing impairment",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* 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.",
                "criterions": [
                    {
                        "exact_snippets": "child is expected to undergo bone marrow transplant (BMT) during the study",
                        "criterion": "child's expected bone marrow transplant during study",
                        "requirement": {
                            "requirement_type": "expected procedure",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "child ... has received BMT within 2 months of study enrollment",
                        "criterion": "child's recent bone marrow transplant",
                        "requirement": {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "child is expected to undergo bone marrow transplant (BMT) during the study",
                        "criterion": "child's expected bone marrow transplant during study",
                        "requirement": {
                            "requirement_type": "expected procedure",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "child ... has received BMT within 2 months of study enrollment",
                        "criterion": "child's recent bone marrow transplant",
                        "requirement": {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* 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.",
                "criterions": [
                    {
                        "exact_snippets": "The child must not be receiving end of life care",
                        "criterion": "end of life care",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "The child must not be receiving end of life care",
                        "criterion": "end of life care",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}