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Family Psychoeducation for Children With Mood Disorders

M

Mary Fristad

Status and phase

Completed
Phase 1

Conditions

Mood Disorders

Treatments

Behavioral: Multifamily Psychoeducation Group (MFPG)
Behavioral: Treatment as usual (TAU)

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00050557
DSIR CT-S
R01MH061512 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness of a Multifamily Psychoeducation Group for the families of children with mood disorders.

Full 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.

Enrollment

165 patients

Sex

All

Ages

8 to 11 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

165 participants in 2 patient groups

1
Experimental group
Description:
Participants will receive immediate Multi-Family Psychoeducation Group treatment and ongoing treatment as usual
Treatment:
Behavioral: Multifamily Psychoeducation Group (MFPG)
Behavioral: Treatment as usual (TAU)
2
Active Comparator group
Description:
Participants will receive treatment as usual and waitlist Multi-Family Psychoeducation Group treatment
Treatment:
Behavioral: Multifamily Psychoeducation Group (MFPG)
Behavioral: Treatment as usual (TAU)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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