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

Pervasive Developmental Disorder Clinical Trial

Official title:

Group Psychoeducational Program for Mothers of Preschool Children With High Functional Pervasive Developmental Disorders: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01243905
• Other study ID #: NCUPsychiatry003
• 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

• Autistic Disorder
• Child Development Disorders, Pervasive
• Developmental Disabilities
• Pervasive Developmental Disorder

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