Group Psychoeducational Program for Mothers of Children With High Functional Pervasive Developmental Disorders

January 18, 2011 updated by: Nagoya City University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

74

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Aichi
      • Nagoya, Aichi, Japan
        • Recruiting
        • Nagoya City University Hospital
        • Contact:
        • Principal Investigator:
          • Masako Suzuki, MD
      • Nagoya, Aichi, Japan, 467-8601
        • Recruiting
        • Nagoya City University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 21 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in the total score of the General Health Questionaire 28(GHQ28) at 7 weeks
Time Frame: the baseline, 7weeks, 21weeks
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
the baseline, 7weeks, 21weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nagoya City University

Investigators

  • Principal Investigator: Masako Suzuki, MD, Nagoya City University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

March 1, 2012

Study Registration Dates

First Submitted

November 8, 2010

First Submitted That Met QC Criteria

November 18, 2010

First Posted (Estimate)

November 19, 2010

Study Record Updates

Last Update Posted (Estimate)

January 19, 2011

Last Update Submitted That Met QC Criteria

January 18, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCUPsychiatry003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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