Mood DisordersPhase 1NCT00050557
Family Psychoeducation for Children With Mood Disorders
A Phase 1 study testing Multifamily Psychoeducation Group (MFPG) and Treatment as usual (TAU) in people with Mood Disorders, run by Mary Fristad at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of a Multifamily Psychoeducation Group for the families of children with mood disorders. Read more about this study
- Who is it for?
- Ages 8 to 11 years
- Conditions the study is for
- Mood Disorders
- What is being tested?
- Multifamily Psychoeducation Group (MFPG) and Treatment as usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2001to Dec 2006
- Phase
- Phase 1
- 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 8 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Major depressive disorder, dysthymic disorder, or bipolar disorder (Type I or II)
- IQ greater than 70
- At least one parent/caregiver willing to participate in the study
- Able to attend six or more of the eight treatment sessions with at least 1 parent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Family Psychoeducation: Efficacy in Child Mood Disorders
The purpose of this study is to evaluate the effectiveness of a Multifamily Psychoeducation Group for the families of children with mood disorders.
Read the detailed description
Mood disorders among youth are a major health concern. Existing mood disorder studies focus on adults, and studies that focus on effective intervention strategies for youth with mood disorders are needed. This 8-session study is an adjunct to ongoing medication management and individual and family psychotherapy for children with mood disorders.
In this study, parents learn about mood disorders, their treatments, and how to work effectively with mental health and school systems. Parents also practice problem-solving and communication skills for symptom management. Children learn about mood disorders and their treatments, including basic cognitive-behavioral principles. Children also learn and practice anger management, problem-solving, and communication skills.
Patients and their families are randomly assigned to 1 of 2 groups. The first group receives 8 sessions of psychoeducation plus treatment as usual (TAU). The second group is a wait-list control in which participants receive only TAU. Patients and caregivers undergo a variety of interviews, tests, and behavioral observations throughout the study. Anxiety, depression, psychosocial stressors, manic symptoms, and children's experiences with psychotropic medications and with treatment or service providers are assessed. Caregivers, teachers, and family friends undergo interviews and make observations of the patient's level of support, general appearance and behavior, and overall functional capacity. The extent to which caregivers agree on the need for treatment and the extent of caregivers' knowledge of mood disorders is also assessed. Assessments occur at 3, 6, 12, 15, and 18 months after study enrollment. A comprehensive assessment is conducted at study entry and 1 year later.
- Conditions
- Mood Disorders
- Being tested
- Multifamily Psychoeducation Group (MFPG), Treatment as usual (TAU)
- Medical subject headings
- Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifamily Psychoeducation Group (MFPG)Behavioural
MFPG will include 8 weekly 90-minute group therapy sessions.
Treatment as usual (TAU)Behavioural
Participants will receive standard care for mood disorders.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive immediate Multi-Family Psychoeducation Group treatment and ongoing treatment as usual Receives: Behavioral: Multifamily Psychoeducation Group (MFPG); Behavioral: Treatment as usual (TAU) |
| 2 | Active comparator | Participants will receive treatment as usual and waitlist Multi-Family Psychoeducation Group treatment Receives: Behavioral: Multifamily Psychoeducation Group (MFPG); Behavioral: Treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mood Severity Index
Measured: Measured at Months 6 and 12
Secondary outcomes (1)
Rage Index (MRS irritability + disruptive-aggressive items)
Measured: Measured at Months 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2002 (estimated)
- Study startJul 2001
- Primary completionSep 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mood DisordersStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mary Fristad
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor-investigator, Mary Fristad, Ohio State University
- Investigators
- Mary A. Fristad, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00050557
- Sponsor's protocol ID
- R01MH061512
- Other IDs
- R01MH061512, DSIR CT-S
- Status last verified
- May 2012
- First submitted
- 13 Dec 2002
- Last updated
- 3 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Boylan K, Macpherson HA, Fristad MA. Examination of disruptive behavior outcomes and moderation in a randomized psychotherapy trial for mood disorders. J Am Acad Child Adolesc Psychiatry. 2013 Jul;52(7):699-708. doi: 10.1016/j.jaac.2013.04.014.
PubMed 23800483Fristad MA, Verducci JS, Walters K, Young ME. Impact of multifamily psychoeducational psychotherapy in treating children aged 8 to 12 years with mood disorders. Arch Gen Psychiatry. 2009 Sep;66(9):1013-21. doi: 10.1001/archgenpsychiatry.2009.112.
PubMed 19736358
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Psychoeducation: Efficacy in Child Mood Disorders
- ClinicalTrials.gov ID
- NCT00050557
- Acronym / sponsor ID
- R01MH061512
- Conditions
- Mood Disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Mary FristadUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2001
- Primary completion
- Sep 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 16 Dec 2002 (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 evaluate the effectiveness of a Multifamily Psychoeducation Group for the families of children with mood disorders.
Detailed description
Mood disorders among youth are a major health concern. Existing mood disorder studies focus on adults, and studies that focus on effective intervention strategies for youth with mood disorders are needed. This 8-session study is an adjunct to ongoing medication management and individual and family psychotherapy for children with mood disorders.
In this study, parents learn about mood disorders, their treatments, and how to work effectively with mental health and school systems. Parents also practice problem-solving and communication skills for symptom management. Children learn about mood disorders and their treatments, including basic cognitive-behavioral principles. Children also learn and practice anger management, problem-solving, and communication skills.
Patients and their families are randomly assigned to 1 of 2 groups. The first group receives 8 sessions of psychoeducation plus treatment as usual (TAU). The second group is a wait-list control in which participants receive only TAU. Patients and caregivers undergo a variety of interviews, tests, and behavioral observations throughout the study. Anxiety, depression, psychosocial stressors, manic symptoms, and children's experiences with psychotropic medications and with treatment or service providers are assessed. Caregivers, teachers, and family friends undergo interviews and make observations of the patient's level of support, general appearance and behavior, and overall functional capacity. The extent to which caregivers agree on the need for treatment and the extent of caregivers' knowledge of mood disorders is also assessed. Assessments occur at 3, 6, 12, 15, and 18 months after study enrollment. A comprehensive assessment is conducted at study entry and 1 year later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Multifamily Psychoeducation Group (MFPG), Behavioral: Treatment as usual (TAU)Participants will receive immediate Multi-Family Psychoeducation Group treatment and ongoing treatment as usual |
| 2 | Active comparator | Behavioral: Multifamily Psychoeducation Group (MFPG), Behavioral: Treatment as usual (TAU)Participants will receive treatment as usual and waitlist Multi-Family Psychoeducation Group treatment |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Major depressive disorder, dysthymic disorder, or bipolar disorder (Type I or II)
- IQ greater than 70
- At least one parent/caregiver willing to participate in the study
- Able to attend six or more of the eight treatment sessions with at least 1 parent
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Multifamily Psychoeducation Group (MFPG)MFPG will include 8 weekly 90-minute group therapy sessions. | Behavioural | 1, 2 |
| Treatment as usual (TAU)Participants will receive standard care for mood disorders. | Behavioural | 1, 2 |
Primary outcome
Mood Severity Index
Time frame: Measured at Months 6 and 12
1 secondary outcome
Rage Index (MRS irritability + disruptive-aggressive items)
Time frame: Measured at Months 6 and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2012.
- Derived from this study: PubMed 23800483Boylan K, Macpherson HA, Fristad MA. Examination of disruptive behavior outcomes and moderation in a randomized psychotherapy trial for mood disorders. J Am Acad Child Adolesc Psychiatry. 2013 Jul;52(7):699-708. doi: 10.1016/j.jaac.2013.04.014.
- Derived from this study: PubMed 19736358Fristad MA, Verducci JS, Walters K, Young ME. Impact of multifamily psychoeducational psychotherapy in treating children aged 8 to 12 years with mood disorders. Arch Gen Psychiatry. 2009 Sep;66(9):1013-21. doi: 10.1001/archgenpsychiatry.2009.112.
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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.
Mary A. Fristad, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Multifamily Psychoeducation Group (MFPG) and Treatment as usual (TAU) in people with Mood Disorders, run by Mary Fristad at 1 site in United States.
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 4 inclusion and 0 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: finished, as of the sponsor's last update on 3 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mood Severity Index (time frame: Measured at Months 6 and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00050557, which also lists 2 linked publications.
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 3 May 2012.