Group Psychoeducational Program for Mothers of Children With High Functional Pervasive Developmental Disorders
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|ClinicalTrials.gov Identifier: NCT01243905|
Recruitment Status : Unknown
Verified January 2011 by Nagoya City University.
Recruitment status was: Recruiting
First Posted : November 19, 2010
Last Update Posted : January 19, 2011
|Condition or disease||Intervention/treatment||Phase|
|Pervasive Developmental Disorder||Other: Family psychoeducational therapy plus TAU Other: Treatment as usual||Phase 2 Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Group Psychoeducational Program for Mothers of Preschool Children With High Functional Pervasive Developmental Disorders: a Randomized Controlled Trial|
|Study Start Date :||September 2010|
|Estimated Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||March 2012|
Active Comparator: Family psychoeducation plus TAU
Family psychoeducational therapy in addition to treatment as usual for the child (TAU)
Other: Family psychoeducational therapy plus TAU
Group psychoeducation every two weeks for eight weeks in addition to treatment as usual administered by physicians
Placebo Comparator: Treatment as usual
Treatment as usual for the child (TAU)
Other: Treatment as usual
Treatment as usual administered by physicians
- Change from baseline in the total score of the General Health Questionaire 28(GHQ28) at 21 weeks [ Time Frame: Baseline, 21 weeks ]GHQ:It is the shorten version of the General Health Questionaire 60. It consists four categories;somatic symptoms,anxiety and insomnia,social dysfunction and depressive tendency.
- Change from baseline in the total score of the General Health Questionaire 28(GHQ28) at 7 weeks [ Time Frame: the baseline, 7weeks, 21weeks ]
- Change from baseline in the total score of the Abnormal Behavior Checklist at 7 weeks [ Time Frame: the baseline, 7weeks, 21weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01243905
|Nagoya City University Hospital||Recruiting|
|Nagoya, Aichi, Japan, 467-8601|
|Contact: Atsurou Yamada, MD, PhD +52-851-5511 ext 3970 firstname.lastname@example.org|
|Nagoya City University Hospital||Recruiting|
|Nagoya, Aichi, Japan|
|Contact: Masako Suzuki, Medical Bachelor email@example.com|
|Principal Investigator: Masako Suzuki, MD|
|Principal Investigator:||Masako Suzuki, MD||Nagoya City University Hospital|