- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02368834
Psychoeducation for the Parents of Attention Deficit Hyperactivity Disorder (ADHD) Children
April 27, 2015 updated by: Li Yang, Peking University
Evaluation of a Psychoeducation Program for the Parents of Attention Deficit Hyperactivity Disorder
This study designed and evaluated a psychoeducation program for parents of ADHD children in terms of improving medication adherence and clinical benefits.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
89
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100191
- Peking university sixth hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: intervention group
A psychoeducation program was delivered to the parents/caregivers
|
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
|
|
No Intervention: control group
This group waited for 3 months, only receiving general consultation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Medication adherence rate
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Li Yang, MD, Peking university sixth hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
February 12, 2015
First Submitted That Met QC Criteria
February 20, 2015
First Posted (Estimate)
February 23, 2015
Study Record Updates
Last Update Posted (Estimate)
April 29, 2015
Last Update Submitted That Met QC Criteria
April 27, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-4024-04-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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