Group Psychoeducational Program for Mothers of Children With High Functional Pervasive Developmental Disorders
1 other identifier
interventional
74
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2010
Shorter than P25 for phase_2
2 active sites
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
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 8, 2010
CompletedFirst Posted
Study publicly available on registry
November 19, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedJanuary 19, 2011
January 1, 2011
1.2 years
November 8, 2010
January 18, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in the total score of the General Health Questionaire 28(GHQ28) at 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.
Baseline, 21 weeks
Secondary Outcomes (2)
Change from baseline in the total score of the General Health Questionaire 28(GHQ28) at 7 weeks
the baseline, 7weeks, 21weeks
Change from baseline in the total score of the Abnormal Behavior Checklist at 7 weeks
the baseline, 7weeks, 21weeks
Study Arms (2)
Family psychoeducation plus TAU
ACTIVE COMPARATORFamily psychoeducational therapy in addition to treatment as usual for the child (TAU)
Treatment as usual
PLACEBO COMPARATORTreatment as usual for the child (TAU)
Interventions
Group psychoeducation every two weeks for eight weeks in addition to treatment as usual administered by physicians
Eligibility Criteria
You may qualify if:
- 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
- Children were diagnosed at more than 3 months before allocation
- Children were between 2 and 6.5 years and have more than 6 months as pre-school period at allocation
- Mothers who are native speakers of Japanese.
- Mothers who are biological mother of and actually bringing their children.
You may not qualify if:
- Mothers who are at risk of taking an emotional toll and unable to understand the contents of psychoeducation for any reason.
- Mothers who are not allowed to participate in this study judged by the doctors of the children for any reason.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Nagoya City University Hospital
Nagoya, Aichi-ken, 467-8601, Japan
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Masako Suzuki, MD
Nagoya City University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 8, 2010
First Posted
November 19, 2010
Study Start
September 1, 2010
Primary Completion
December 1, 2011
Study Completion
March 1, 2012
Last Updated
January 19, 2011
Record last verified: 2011-01