Pervasive Developmental DisorderPhase 2/3NCT01243905
Group Psychoeducational Program for Mothers of Children With High Functional Pervasive Developmental Disorders
A Phase 2/3 study testing Family psychoeducational therapy plus TAU and Treatment as usual in people with Pervasive Developmental Disorder, run by Nagoya City University at 2 sites in Japan.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pervasive Developmental Disorder
- What is being tested?
- Family psychoeducational therapy plus TAU and Treatment as usual
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 2 sitesJapan
- Study dates
- Sep 2010to Mar 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Japan2 sites, 2 recruiting
- Recruiting
Nagoya City University Hospital
Nagoya, Aichi-ken, 467-8601
Atsurou Yamada, MD, PhD, +52-851-5511 ext. 3970, atsurou@med.nagoya-cu.ac.jp
- Recruiting
Nagoya City University Hospital
Nagoya, Aichi-ken
Masako Suzuki, Medical Bachelor, masako8886@leaf.ocn.ne.jp
Masako Suzuki, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Pervasive Developmental Disorder
- Being tested
- Family psychoeducational therapy plus TAU, Treatment as usual
- Medical subject headings
- Child Development Disorders, Pervasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family psychoeducational therapy plus TAUOther
Group psychoeducation every two weeks for eight weeks in addition to treatment as usual administered by physicians
Treatment as usualOther
Treatment as usual administered by physicians
| Study group | Role | What they receive |
|---|---|---|
| Family psychoeducation plus TAU | Active comparator | Family psychoeducational therapy in addition to treatment as usual for the child (TAU) Receives: Other: Family psychoeducational therapy plus TAU |
| Treatment as usual | Placebo comparator | Treatment as usual for the child (TAU) Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 21 weeks
Secondary outcomes (2)
Change from baseline in the total score of the General Health Questionaire 28(GHQ28) at 7 weeks
Measured: the baseline, 7weeks, 21weeks
Change from baseline in the total score of the Abnormal Behavior Checklist at 7 weeks
Measured: the baseline, 7weeks, 21weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2011 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pervasive Developmental DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nagoya City University
- Sponsor type
- University, hospital or other
- Investigators
- Masako Suzuki, MD, Principal investigator, Nagoya City University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01243905
- Sponsor's protocol ID
- NCUPsychiatry003
- Status last verified
- Jan 2011
- First submitted
- 8 Nov 2010
- Last updated
- 19 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Psychoeducational Program for Mothers of Preschool Children With High Functional Pervasive Developmental Disorders: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01243905
- Acronym / sponsor ID
- NCUPsychiatry003
- Conditions
- Pervasive Developmental Disorder
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Nagoya City UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 19 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family psychoeducation plus TAU | Active comparator | Other: Family psychoeducational therapy plus TAUFamily psychoeducational therapy in addition to treatment as usual for the child (TAU) |
| Treatment as usual | Placebo comparator | Other: Treatment as usualTreatment as usual for the child (TAU) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family psychoeducational therapy plus TAUGroup psychoeducation every two weeks for eight weeks in addition to treatment as usual administered by physicians | Other | Family psychoeducation plus TAU |
| Treatment as usualTreatment as usual administered by physicians | Other | Treatment as usual |
Primary outcome
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.
2 secondary outcomes
Change from baseline in the total score of the General Health Questionaire 28(GHQ28) at 7 weeks
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masako Suzuki, MD principal investigator
Nagoya City University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Family psychoeducational therapy plus TAU and Treatment as usual in people with Pervasive Developmental Disorder, run by Nagoya City University at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the total score of the General Health Questionaire 28(GHQ28) at 21 weeks (time frame: Baseline, 21 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2011; AzTrials last refreshed its copy on 6 Nov 2026.