Group Psychoeducational Program for Mothers of Children With High Functional Pervasive Developmental Disorders
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pervasive Developmental Disorder |
Other: Family psychoeducational therapy plus TAU Other: Treatment as usual |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Group Psychoeducational Program for Mothers of Preschool Children With High Functional Pervasive Developmental Disorders: a Randomized Controlled Trial |
- Change from baseline in the total score of the General Health Questionaire 28(GHQ28) at 21 weeks [ Time Frame: Baseline, 21 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Change from baseline in the total score of the Abnormal Behavior Checklist at 7 weeks [ Time Frame: the baseline, 7weeks, 21weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 74 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Japan | |
| Nagoya City University Hospital | Recruiting |
| Nagoya, Aichi, Japan | |
| Contact: Masako Suzuki, Medical Bachelor masako8886@leaf.ocn.ne.jp | |
| Principal Investigator: Masako Suzuki, MD | |
| Nagoya City University Hospital | Recruiting |
| Nagoya, Aichi, Japan, 467-8601 | |
| Contact: Atsurou Yamada, MD, PhD +52-851-5511 ext 3970 atsurou@med.nagoya-cu.ac.jp | |
| Principal Investigator: | Masako Suzuki, MD | Nagoya City University Hospital |
More Information
No publications provided
| Responsible Party: | Masako Suzuki, Nagoya City University Graduate School of Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT01243905 History of Changes |
| Other Study ID Numbers: | NCUPsychiatry003 |
| Study First Received: | November 8, 2010 |
| Last Updated: | January 18, 2011 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Additional relevant MeSH terms:
|
Developmental Disabilities Child Development Disorders, Pervasive Mental Disorders Diagnosed in Childhood Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013