Viewing Study NCT01243905


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Study NCT ID: NCT01243905
Status: UNKNOWN
Last Update Posted: 2011-01-19
First Post: 2010-11-08
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Group Psychoeducational Program for Mothers of Children With High Functional Pervasive Developmental Disorders
Sponsor: Nagoya City University
Organization:

Study Overview

Official Title: Group Psychoeducational Program for Mothers of Preschool Children With High Functional Pervasive Developmental Disorders: a Randomized Controlled Trial
Status: UNKNOWN
Status Verified Date: 2011-01
Last Known Status: 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: The purpose of this study is to examine the effectiveness of group psychoeducation for the psychological distress of mothers with the children of high-functioning pervasive developmental disorder and for their behavior based on disorder traits.
Detailed Description: Pervasive Developmental Disorder (PDD) is defined by its unique symptoms such as qualitative impairment in social interaction and communication and restricted repetitive and stereotyped patterns of behavior and interests. Recently, studies have been conducted on PDD without mental retardation, and have reported that the morbidity of PDD is 0.6%-1.7%. Several studies have focused on distress of the mothers of PDD facing atypical development of their children. Some of them have indicated the associations between depression and family history of PDD. Therefore it is important to pay attention to parental mental health.

In Western countries, researchers have investigated the effectiveness of various psychotherapeutic techniques such as childcare counseling and education for mothers about how to treat their children with PDD. It has been reported that one of them which innovates pragmatical methods to manage their children and parental educational programs made improvement in parental adaptation to their children and parental mental health.

However, to the best of our knowledge, few studies have shown the effectiveness of family intervention about PDD in Japan, despite widely implementation of family psychoeducation with various approaches in medical center, public health department. New research may be needed to establish rigorous evidence base for improvement of parental mental health and of behaviors of their children with PDD.

The investigators hypothesized that psychoeducation programs for mothers in addition to treatment as usual to their children would be more effective for parental mental health and behaviors of their children with PDD than treatment usual to their children alone.

The purpose of this study is to examine the effectiveness of psychoeducation to the psychological distress of mothers with the children of high-functioning PDD and to behaviors of the children affected by disorder traits, in a randomized controlled trial.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: