Family-Centered Intervention for Preterm Children: Effects at School Age and Biosocial Mediators
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03668626|
Recruitment Status : Not yet recruiting
First Posted : September 12, 2018
Last Update Posted : September 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Premature Birth||Other: Family-centered intervention program (FCIP)||Not Applicable|
|Study Type :||Interventional|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Family-Centered Intervention for Preterm Children: Effects at School Age and Biosocial Mediators|
|Estimated Study Start Date :||September 2018|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
No Intervention: Term infants
Healthy term infants
No Intervention: Usual care program (UCP)
In-hospital and after-discharge intervention (telephone calls)
Experimental: Family-centered intervention program (FCIP)
In-hospital and after-discharge intervention (clinic and home visits)
Other: Family-centered intervention program (FCIP)
This program will include in-hospital intervention, after-discharge intervention and neonatal follow-up. Five sessions of in-hospital intervention will emphasize modulation of the NICU, teaching of child developmental skills, feeding support, massage, interactional activities and parent support and education. The 7-session after-discharge intervention will consist of 4 clinic visits and 3 home visits with specific care in modulation of home environment, teaching of child developmental skills, feeding support, teaching of interactional activities, and parent support and education.
Other Name: early intervention program
- Child: Neurodevelopment- The Wechsler Preschool and Primary Scale of Intelligence-Fourth Edition [ Time Frame: 2 years ]The Wechsler Preschool and Primary Scale of Intelligence-Fourth Edition (WPPSIR-IV) measures cognitive development of children aged from 6 years to 16 years and 11 months old. The test structure of WPPSIR-IV includes 14 subscales and several levels of interpretation: verbal comprehension index, perceptual reasoning index, working memory index, processing speed index and full scale intelligence quotient. The scaled score of each subscale ranges from 1 to 19. The total scaled score is the sum of the subscale scores ranging from 10 to 190. The full scale intelligence quotient will be converted from the total scaled score with a higher value indicating a better performance.
- Child: Past medical history [ Time Frame: up to 2 years ]Past 1-year medical history is recorded by parental interview.
- Child: Academic performance [ Time Frame: up to 2 years ]Parent interview
- Child: Neurodevelopment - Movement Assessment Battery for Children- 2nd Edition [ Time Frame: 2 years ]The Movement Assessment Battery for Children- 2nd Edition examines the motor performance in children aged 3 years to 16 years and 11 months. The assessment contains eight items that measure a child's performance of age-appropriate tasks in the aspects of manual dexterity, aiming and catching, and balance. The scaled score of each subscale ranges from 1 to 19. The total score is the sum of the raw scores of the subscales and can be converted to scaled score, ranging from 10 to 190, and percentile. A higher score indicates a better performance.
- Child: Electroencephalogram (EEG) [ Time Frame: 2 years ]Electroencephalogram (EEG) will be measured in the resting state for the participating children at 7 years of age.
- Child: Event-related potential (ERP) [ Time Frame: 2 years ]Event-related potential (ERP) will be measured in the cognitive inhibitory control and working memory procedures and cognition/motor dual tasks with ERP technique for the participating children at 7 years of age.
- Parent function-pressure [ Time Frame: 2 years ]Parenting Stress Index measures stress of parents of children aged 1 month to 12 years. The total score ranges from 94 to 486, with a higher score indicating a higher stress.
- Parent function-quality of Life [ Time Frame: 2 years ]World Health Organization Quality of Life- Brief Taiwan version has a total score ranging from 34 to 170. A higher score indicates a better quality of life.
- Child: Behavior - Child Behavior Check List/ 4-18 [ Time Frame: 2 years ]The Child Behavior Check List/ 4-18 is a parent-report questionnaire designed to assess the behavior problems in children at 4 to 18 years of age. The CBCL/4-18 consists of 138 items to assess child's behavioral/emotional problems. The total score ranges from 0 to 200, with a higher score indicating a worse behavior.
- Child: Behavior - Swanson, Nolan, and Pelham Questionnaire, version IV [ Time Frame: Time Frame: 1 year ]
The Swanson, Nolan, and Pelham Questionnaire, version IV questionnaire examines the severity of ADHD and ODD in preschool- and school-aged children. The scale employs the direct symptom of Diagnosis and Statistical Manual of Mental Disorder-IV (DSM-IV) that consists of inattention (nine items), hyperactivity/impulsivity (nine items) of the criteria for ADHD, and the oppositional symptoms (eight items) of the criteria for ODD.
The total score ranges from 0 to 73, a higher score indicating a worse performance.
- Child: Growth - weight [ Time Frame: up to 2 years ]weight will be assessed using an electric weight scale (kg)
- Child: Growth - height [ Time Frame: up to 2 years ]height will be assessed by the tape measure in standing position (cm)
- Child: Growth - head circumference [ Time Frame: up to 2 years ]head circumference will be assessed as the largest dimension around the head obtained with a type measure placed snugly above the ears (cm)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668626
|Contact: Suh-Fang Jeng, Professoremail@example.com|
|Contact: Nai-Jia Yao, Masterfirstname.lastname@example.org|
|Principal Investigator:||Suh-Fang Jeng, Professor||School and Graduate Institute of Physical Therapy, National Taiwan University|