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Completed

NCT Number: NCT00404911

Multi-Family Group Therapy for Reducing Behavioral Difficulties in Youth

This study will examine the effectiveness of a multiple family group mental health service delivery strategy in improving mental health service use and outcome for urban, low income children of color, ages 7-11 years old with disruptive behaviors and their families.

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Key information

Age range

7 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai's Child and Adolescent Outpatient Psychiatry Clinic

New York, 10029, United States

About this study

Oppositional defiant disorder (ODD) and conduct disorder (CD) are two common childhood psychiatric disorders. Children with ODD frequently have temper tantrums, argue excessively with adults, deliberately attempt to annoy or upset people, and blame others for their mistakes or behavior. Children with CD may exhibit aggression toward people and animals, destruction of property, deceitfulness, and rule breaking. The symptoms of these disorders can negatively affect children's social, family, and academic lives. Research has shown that early, comprehensive treatment leads to better treatment outcomes. Both disorders are commonly treated using parent training techniques. A multiple family group therapy setting may prove to be more engaging and beneficial than standard care for both parents and children. This study will examine the effectiveness of a multiple family group (MFG) mental health service delivery strategy in improving mental health service use and treatment outcome for urban, low income children of color with ODD or CD.

Participants in this 18-month, open-label study will be randomly assigned to either receive standard of care or participate in an MFG in addition to receiving standard of care. Participants assigned to standard of care will receive treatment that is traditionally offered to outpatients. Participants in an MFG will meet in their groups once a week for 16 weeks. Sessions will include adult caregivers and all children over age 6. Each session will follow the same procedures, and will proceed through the following stages: creating social networks; information exchange; group discussions; individual family practice; and homework assignment. Assessments of youth functioning will be held at Weeks 8 and 16 and Months 6 and 18 post-treatment.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Youth participants are between the ages of 7 and 11
  • Adult caregivers are available to participate in the research and intervention activities
  • Both youth and adult caregiver are English- or Spanish-speaking
  • Youth meets criteria for a primary diagnosis of oppositional defiant disorder or conduct disorder, as measured by the Disruptive Behavior Disorder Rating Scale (DBD)

Exclusion criteria

  • Youth has significant cognitive impairment that might interfere with understanding of program content or informed consent process
  • Youth or adult has emergency psychiatric needs that require services beyond those provided within an outpatient setting (e.g., hospitalization or specialized placement outside the home)
  • Youth who are wards of the state

Treatment and study plan

MFG therapy

Behavioral

MFG includes 16 weekly group therapy sessions for families with children who have ODD or CD. Sessions will include adult caregivers and all children over age 6. Each session will follow the same procedures, and will proceed through the following stages: creating social networks; information exchange; group discussions; individual family practice; and homework assignment.

Other names: Multiple Family Group Project

Standard of Care

Behavioral

Participants assigned to standard care will receive treatment that is traditionally offered to outpatients. Participants in the MFG program will also receive standard care.

Other names: Multiple Family Group Project, Standard care control

Primary outcomes

  1. Youth externalizing behaviors and functioning

    Time frame: Measured at week 16 of treatment

  2. Youth externalizing behaviors and functioning

    Time frame: Measured 6 Months follow-up visit

Secondary outcomes

  1. Parenting skills

    Time frame: 16 weeks and 6 months

    change in parenting skills after intervention

  2. Involvement in child mental health care

    Time frame: 16 weeks and 6 months

    comparison of involvement in child mental health care after intervention

  3. Parent/child interaction

    Time frame: 16 weeks and 6 months

    change in parent and child interaction after intervention

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Family Groups to Reduce Youth Behavioral Difficulties

Important dates

Study start
2006
Primary completion
2013
Study completion
2013
First posted
Nov 29, 2006
Registry last updated
Jun 25, 2013

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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