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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
Sponsor:
Information provided by:
Nagoya City University

November 8, 2010
November 19, 2010
January 19, 2011
September 2010
December 2011   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01243905 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Group Psychoeducational Program for Mothers of Children With High Functional Pervasive Developmental Disorders
Group Psychoeducational Program for Mothers of Preschool Children With High Functional Pervasive Developmental Disorders: a Randomized Controlled Trial
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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pervasive Developmental Disorder
  • Other: Family psychoeducational therapy plus TAU
    Group psychoeducation every two weeks for eight weeks in addition to treatment as usual administered by physicians
  • Other: Treatment as usual
    Treatment as usual administered by physicians
  • Active Comparator: Family psychoeducation plus TAU
    Family psychoeducational therapy in addition to treatment as usual for the child (TAU)
    Intervention: Other: Family psychoeducational therapy plus TAU
  • Placebo Comparator: Treatment as usual
    Treatment as usual for the child (TAU)
    Intervention: Other: Treatment as usual
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
74
Same as current
March 2012
December 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Mothers whose children have been diagnosed with any disorders by DSM-Ⅳ-TR as: 1) Autistic disorder and not mental retardation; 2) Asperger disorder; or 3) Pervasive developmental disorder not otherwise specified and not mental retardation
  2. Children were diagnosed at more than 3 months before allocation
  3. Children were between 2 and 6.5 years and have more than 6 months as pre-school period at allocation
  4. Mothers who are native speakers of Japanese.
  5. Mothers who are biological mother of and actually bringing their children.

Exclusion Criteria:

  1. Mothers who are at risk of taking an emotional toll and unable to understand the contents of psychoeducation for any reason.
  2. Mothers who are not allowed to participate in this study judged by the doctors of the children for any reason.
Sexes Eligible for Study: Female
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01243905
NCUPsychiatry003
No
Not Provided
Not Provided
Masako Suzuki, Nagoya City University Graduate School of Medical Sciences
Nagoya City University
Not Provided
Principal Investigator: Masako Suzuki, MD Nagoya City University Hospital
Nagoya City University
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP