Group Psychoeducational Program for Mothers of Children With High Functional Pervasive Developmental Disorders
Primary Purpose
Pervasive Developmental Disorder
Status
Unknown status
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Family psychoeducational therapy plus TAU
Treatment as usual
Sponsored by
About this trial
This is an interventional treatment trial for Pervasive Developmental Disorder
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Nagoya City University HospitalRecruiting
- Nagoya City University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Family psychoeducation plus TAU
Treatment as usual
Arm Description
Family psychoeducational therapy in addition to treatment as usual for the child (TAU)
Treatment as usual for the child (TAU)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change from baseline in the total score of the General Health Questionaire 28(GHQ28) at 7 weeks
Change from baseline in the total score of the Abnormal Behavior Checklist at 7 weeks
Full Information
NCT ID
NCT01243905
First Posted
November 8, 2010
Last Updated
January 18, 2011
Sponsor
Nagoya City University
1. Study Identification
Unique Protocol Identification Number
NCT01243905
Brief Title
Group Psychoeducational Program for Mothers of Children With High Functional Pervasive Developmental Disorders
Official Title
Group Psychoeducational Program for Mothers of Preschool Children With High Functional Pervasive Developmental Disorders: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
March 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Nagoya City University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pervasive Developmental Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Family psychoeducation plus TAU
Arm Type
Active Comparator
Arm Description
Family psychoeducational therapy in addition to treatment as usual for the child (TAU)
Arm Title
Treatment as usual
Arm Type
Placebo Comparator
Arm Description
Treatment as usual for the child (TAU)
Intervention Type
Other
Intervention Name(s)
Family psychoeducational therapy plus TAU
Intervention Description
Group psychoeducation every two weeks for eight weeks in addition to treatment as usual administered by physicians
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Intervention Description
Treatment as usual administered by physicians
Primary Outcome Measure Information:
Title
Change from baseline in the total score of the General Health Questionaire 28(GHQ28) at 21 weeks
Description
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.
Time Frame
Baseline, 21 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in the total score of the General Health Questionaire 28(GHQ28) at 7 weeks
Time Frame
the baseline, 7weeks, 21weeks
Title
Change from baseline in the total score of the Abnormal Behavior Checklist at 7 weeks
Time Frame
the baseline, 7weeks, 21weeks
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masako Suzuki, MD
Organizational Affiliation
Nagoya City University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nagoya City University Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
467-8601
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atsurou Yamada, MD, PhD
Phone
+52-851-5511
Ext
3970
Email
atsurou@med.nagoya-cu.ac.jp
Facility Name
Nagoya City University Hospital
City
Nagoya
State/Province
Aichi
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masako Suzuki, Medical Bachelor
Email
masako8886@leaf.ocn.ne.jp
First Name & Middle Initial & Last Name & Degree
Masako Suzuki, MD
12. IPD Sharing Statement
Learn more about this trial
Group Psychoeducational Program for Mothers of Children With High Functional Pervasive Developmental Disorders
We'll reach out to this number within 24 hrs