Back to resultsPsychoeducation for the Parents of Attention Deficit Hyperactivity Disorder (ADHD) Children
Primary Purpose
ADHD
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
psychoeducation
Sponsored by
About this trial
This is an interventional supportive care trial for ADHD
Eligibility Criteria
Inclusion Criteria:
- parents of ADHD children diagnosed with ADHD
- 6 - 16 years old;
- first referral to the hospital;
- candidate for medication according to both the doctor and the family
Exclusion Criteria:
- inappropriate for medication;
- being illiterate of the parent or the primary caregiver;
- unable to be followed-up.
Sites / Locations
- Peking University Sixth Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention group
control group
Arm Description
A psychoeducation program was delivered to the parents/caregivers
This group waited for 3 months, only receiving general consultation.
Outcomes
Primary Outcome Measures
Medication adherence rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02368834
Brief Title
Psychoeducation for the Parents of Attention Deficit Hyperactivity Disorder (ADHD) Children
Official Title
Evaluation of a Psychoeducation Program for the Parents of Attention Deficit Hyperactivity Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study designed and evaluated a psychoeducation program for parents of ADHD children in terms of improving medication adherence and clinical benefits.
Detailed Description
ADHD is the most common behavioral disorder with poor outcomes. Medication is the most important treatment for ADHD. The adherence to the medication is extremely low. This study aims to investigate the the effect of a psychoeducation program for parents of ADHD children. The investigators intent to recruit 80 ADHD families. They will be randomized to intervention group and control group using a block randomization design. The intervention group will participate in a psychoeducation program, which includes a presentation from a specialist in ADHD at the baseline, with parent manual provided, posters, and two group sessions at the end of the 2nd and the 4th weeks. The control group only receives general consultation. The knowledge towards ADHD and its treatment, parents' behavior intent, medication adherence, clinical symptoms, and parents' satisfaction will be assessed and compared at the end of the 1st and 3rd months after intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Experimental
Arm Description
A psychoeducation program was delivered to the parents/caregivers
Arm Title
control group
Arm Type
No Intervention
Arm Description
This group waited for 3 months, only receiving general consultation.
Intervention Type
Behavioral
Intervention Name(s)
psychoeducation
Intervention Description
The intervention included a presentation by a psychiatrist, with parent manual provided, and then two group sessions at the 2nd and 4th weeks to address further concerns of the parents
Primary Outcome Measure Information:
Title
Medication adherence rate
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
parents of ADHD children diagnosed with ADHD
6 - 16 years old;
first referral to the hospital;
candidate for medication according to both the doctor and the family
Exclusion Criteria:
inappropriate for medication;
being illiterate of the parent or the primary caregiver;
unable to be followed-up.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Yang, MD
Organizational Affiliation
Peking University Sixth Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Sixth Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
12. IPD Sharing Statement
Learn more about this trial
Psychoeducation for the Parents of Attention Deficit Hyperactivity Disorder (ADHD) Children
We'll reach out to this number within 24 hrs