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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01243905
Other study ID # NCUPsychiatry003
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received November 8, 2010
Last updated January 18, 2011
Start date September 2010
Est. completion date March 2012

Study information

Verified date January 2011
Source Nagoya City University
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 74
Est. completion date March 2012
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

1. Mothers whose children have been diagnosed with any disorders by DSM-?-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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Family psychoeducational therapy plus TAU
Group psychoeducation every two weeks for eight weeks in addition to treatment as usual administered by physicians
Treatment as usual
Treatment as usual administered by physicians

Locations

Country Name City State
Japan Nagoya City University Hospital Nagoya Aichi
Japan Nagoya City University Hospital Nagoya Aichi

Sponsors (1)

Lead Sponsor Collaborator
Nagoya City University

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Change from baseline in the total score of the General Health Questionaire 28(GHQ28) at 7 weeks the baseline, 7weeks, 21weeks No
Secondary Change from baseline in the total score of the Abnormal Behavior Checklist at 7 weeks the baseline, 7weeks, 21weeks No
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