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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Nagoya City University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Nagoya City University
ClinicalTrials.gov Identifier:
NCT01243905
First received: November 8, 2010
Last updated: January 18, 2011
Last verified: January 2011
  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

Resource links provided by NLM:


Further study details as provided by Nagoya City University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01243905

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   
Sponsors and Collaborators
Nagoya City University
Investigators
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 July 28, 2014