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Completed

NCT Number: NCT00050557

Family Psychoeducation for Children With 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.

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Key information

Conditions

Mood Disorders Mental Disorders

Age range

8 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ohio State University

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

Multifamily Psychoeducation Group (MFPG)

Behavioral

MFPG will include 8 weekly 90-minute group therapy sessions.

Treatment as Usual (TAU)

Behavioral

Participants will receive standard care for mood disorders.

Primary outcomes

  1. Mood Severity Index

    Time frame: Measured at Months 6 and 12

Secondary outcomes

  1. Rage Index (MRS irritability + disruptive-aggressive items)

    Time frame: Measured at Months 6 and 12

Sponsors and collaborators

Lead sponsor

Mary Fristad

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Family Psychoeducation: Efficacy in Child Mood Disorders

Important dates

Study start
2001
Primary completion
2006
Study completion
2006
First posted
Dec 16, 2002
Registry last updated
May 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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