NCT02368834

Brief Summary

This study designed and evaluated a psychoeducation program for parents of ADHD children in terms of improving medication adherence and clinical benefits.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 23, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Last Updated

April 29, 2015

Status Verified

April 1, 2015

Enrollment Period

8 months

First QC Date

February 12, 2015

Last Update Submit

April 27, 2015

Conditions

ADHD

Outcome Measures

Primary Outcomes (1)

  • Medication adherence rate

    3 months

Study Arms (2)

intervention group

EXPERIMENTAL

A psychoeducation program was delivered to the parents/caregivers

Behavioral: psychoeducation

control group

NO INTERVENTION

This group waited for 3 months, only receiving general consultation.

Interventions

psychoeducationBEHAVIORAL

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

intervention group

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • parents of ADHD children diagnosed with ADHD
  • years old;
  • first referral to the hospital;
  • candidate for medication according to both the doctor and the family

You may not qualify if:

  • inappropriate for medication;
  • being illiterate of the parent or the primary caregiver;
  • unable to be followed-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Sixth Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Li Yang, MD

    Peking University Sixth Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 12, 2015

First Posted

February 23, 2015

Study Start

August 1, 2014

Primary Completion

April 1, 2015

Last Updated

April 29, 2015

Record last verified: 2015-04

Locations

CN(1)