Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-01-20 @ 10:52 PM
Study NCT ID:
NCT04237259
Status:
UNKNOWN
Last Update Posted:
2020-02-05
First Post:
2020-01-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Traditional Chinese Medicine Pediatric Massage for Attention Deficit Hyperactivity Disorder Symptoms
Sponsor:
The Hong Kong Polytechnic University
Organization:
Study Overview
Official Title:
Traditional Chinese Medicine (TCM) Pediatric Massage for the Treatment of Attention Deficit Hyperactivity Disorder (ADHD) Symptoms in Preschool Children: A Pilot Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
NOT_YET_RECRUITING
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:
None
Brief Summary:
This project is designed to preliminarily assess the effects and feasibility of parent-delivered TCM pediatric massage for ADHD symptoms in preschool children.
Detailed Description:
Objectives: To preliminarily assess the effects and feasibility of parent-delivered TCM pediatric massage for ADHD symptoms in preschool children.
Hypothesis: The parent-delivered TCM pediatric massage group would have greater improvement in children's hyperactivity, anxiety, and sleep disturbance symptoms when compared to the parent-child interaction group.
Design and subjects: In this pilot randomized controlled trial, 60 pair of children with pre-specified ADHD symptoms and their parent will be recruited and randomized to parent-administered TCM pediatric massage comparison group, and parent-child interaction group at a 1: 1 ratio.
Interventions: Parents of subjects in the parent-administered TCM massage group (n=30) will attend 2 training sessions (5 hours in total) to learn and practice the parent-administered TCM massage for ADHD before treatment starts. The parents will be told to practice the TCM massage on their child every 2 days for 2 months. Parents in the parent-child interaction group (comparison group, n=30) will attend a 3-hour training course on line and spend extra time on interacting with their child at home.
Main outcome measures: The primary outcome measure is the Swanson, Nolan and Pelham Parent Scale (SNAP-IV-P). Other outcomes include Preschool Anxiety Scale (PAS), Children's Sleep Habits Questionnaire (CSHQ), Parental Stress Scale (PSS) for parental stress, and the Clinical Global Impression (CGI).
Data Analysis: Differences in the scale scores and test parameters between groups will be examined using a linear mixed-effects model.
Expected results: Subjects in the parent-administered TCM massage group will have greater improvements in the ADHD symptoms compared to those in the parent-child interaction group at week 4 and week 8.
Hypothesis: The parent-delivered TCM pediatric massage group would have greater improvement in children's hyperactivity, anxiety, and sleep disturbance symptoms when compared to the parent-child interaction group.
Design and subjects: In this pilot randomized controlled trial, 60 pair of children with pre-specified ADHD symptoms and their parent will be recruited and randomized to parent-administered TCM pediatric massage comparison group, and parent-child interaction group at a 1: 1 ratio.
Interventions: Parents of subjects in the parent-administered TCM massage group (n=30) will attend 2 training sessions (5 hours in total) to learn and practice the parent-administered TCM massage for ADHD before treatment starts. The parents will be told to practice the TCM massage on their child every 2 days for 2 months. Parents in the parent-child interaction group (comparison group, n=30) will attend a 3-hour training course on line and spend extra time on interacting with their child at home.
Main outcome measures: The primary outcome measure is the Swanson, Nolan and Pelham Parent Scale (SNAP-IV-P). Other outcomes include Preschool Anxiety Scale (PAS), Children's Sleep Habits Questionnaire (CSHQ), Parental Stress Scale (PSS) for parental stress, and the Clinical Global Impression (CGI).
Data Analysis: Differences in the scale scores and test parameters between groups will be examined using a linear mixed-effects model.
Expected results: Subjects in the parent-administered TCM massage group will have greater improvements in the ADHD symptoms compared to those in the parent-child interaction group at week 4 and week 8.
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?: