Parent Training to Promote Early Identification and Treatment of Childhood Behavioral Disorders

NCT ID: NCT00402857

Last Updated: 2013-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 345 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2011-12-31

Brief Summary

This study will evaluate the effectiveness of a parent training program in improving parenting skills and reducing behavioral symptoms in young children who are at risk for developing childhood behavior disorders.

Detailed Description

Attention deficit hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD) are common childhood behavior disorders. Children with ADHD experience hyperactivity, distractibility, poor concentration, and impulsivity. If left untreated, ADHD can continue into adulthood, and can cause problems in family, social, and work environments. Children with ODD exhibit an ongoing pattern of uncooperative, defiant, and hostile behavior toward authority figures. Symptoms of ODD, including frequent temper tantrums, anger, resentment, and vindictiveness, may interfere with a child's everyday functioning. The Incredible Years parent training program has been shown to be effective in multiple settings at training parents to manage their child's behavior. This study will evaluate the effectiveness of the Incredible Years training program within a pediatric office setting at improving parenting skills and reducing behavioral symptoms in young children who are at risk for developing childhood behavior disorders.

Participants in this open-label study will be randomly assigned to the Incredible Years training program or a waitlist condition, in which they will begin the program after a 1-year waiting period. Parent training sessions will take place once per week for 10 weeks, and will last approximately 2 hours each. Sessions will focus on teaching positive parenting skills, such as appropriate play and use of praise and rewards, as well as limit-setting techniques, such as ignoring, allowing children to experience the natural consequences of their actions, and assigning time-outs. Self-report assessments and phone interviews will be used to assess outcomes. Additionally, follow-up visits will occur immediately post-intervention and 6 and 12 months post-intervention. Children will attend one visit before the program begins, as well as the follow-ups held immediately post-intervention and 12 months post-intervention. These visits will include videotaped observations of children and their primary caregivers.

Conditions

Attention Deficit Disorder With Hyperactivity; Attention Deficit and Disruptive Behavior Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Participants will receive the Incredible Years Program, a group parenting intervention

Group Type: EXPERIMENTAL

Incredible Years Program

Intervention Type: BEHAVIORAL

The Incredible Years Program is a 10-week group parenting intervention. Parent training sessions will take place once per week for 10 weeks, and will last approximately 2 hours each. Sessions will focus on teaching positive parenting skills, such as appropriate play and use of praise and rewards, as well as limit-setting techniques, such as ignoring, allowing children to experience the natural consequences of their actions, and assigning time-outs.

2

Participants assigned to the waitlist condition will receive the Incredible Years Program after a 1-year waiting period

Group Type: OTHER

Incredible Years Program

Intervention Type: BEHAVIORAL

The Incredible Years Program is a 10-week group parenting intervention. Parent training sessions will take place once per week for 10 weeks, and will last approximately 2 hours each. Sessions will focus on teaching positive parenting skills, such as appropriate play and use of praise and rewards, as well as limit-setting techniques, such as ignoring, allowing children to experience the natural consequences of their actions, and assigning time-outs.

Interventions

Incredible Years Program

The Incredible Years Program is a 10-week group parenting intervention. Parent training sessions will take place once per week for 10 weeks, and will last approximately 2 hours each. Sessions will focus on teaching positive parenting skills, such as appropriate play and use of praise and rewards, as well as limit-setting techniques, such as ignoring, allowing children to experience the natural consequences of their actions, and assigning time-outs.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Parent or primary caregiver of a child who fits the following criteria:

• Receives a positive result on behavioral screening

Exclusion Criteria

Parent or primary caregiver of a child who fits the following criteria:

• Diagnosis of pervasive developmental disorder or global developmental delay

• Minimum Eligible Age: 22 Months
• Maximum Eligible Age: 38 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Tufts Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ellen C. Perrin, MD

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Center

Christopher Sheldrick, PhD

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Center

Jannette McMenamy, PhD

Role: PRINCIPAL_INVESTIGATOR

Fitchburg State College

Locations

MGH Chelsea Healthcare Center

Chelsea, Massachusetts, United States

Codman Square Health Center

Dorchester, Massachusetts, United States

Martha Eliot Health Center

Jamaica Plain, Massachusetts, United States

Medical Associates Pediatrics

Leominster, Massachusetts, United States

Southboro Medical Group

Southborough, Massachusetts, United States

Pediatrics West

Westford, Massachusetts, United States

Westwood-Mansfield Pediatric Associates

Westwood, Massachusetts, United States

Wilmington Pediatrics

Wilmington, Massachusetts, United States

Woburn Pediatric Associates

Woburn, Massachusetts, United States

Countries

United States

References

Perrin EC, Sheldrick RC, McMenamy JM, Henson BS, Carter AS. Improving parenting skills for families of young children in pediatric settings: a randomized clinical trial. JAMA Pediatr. 2014 Jan;168(1):16-24. doi: 10.1001/jamapediatrics.2013.2919.

Reference Type: DERIVED

PMID: 24190691 (View on PubMed)

Other Identifiers

R01MH076244

Identifier Type: NIH

Identifier Source: secondary_id

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DSIR CT-C

Identifier Type: -

Identifier Source: secondary_id

R01MH076244

Identifier Type: NIH

Identifier Source: org_study_id

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