Clinical trial NCT00402857: Parent Training to Promote Early Identification and Treatment of Childhood Behavioral Disorders
Official title: Advanced Parenting Education in Pediatrics: The APEP Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention Deficit Disorder With Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Keywords: Parenting Education
Child, Preschool
Preventive Intervention
Primary Health Care
Pediatrics
Attention Deficit Disorders
Oppositional Defiant Disorder
Disruptive Behavior Disorder
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2006-11-22
Enrollment: 345
Sex: ALL
Minimum age (years): 22
Maximum age (years): 38
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Parenting behavior
timeFrame: Measured post-intervention and at 6- and 12-month follow-ups
measure: Child disruptive behaviors
timeFrame: Measured post-intervention and at 6- and 12-month follow-ups
Secondary outcomes:
measure: Child and parent functional status/impairment
timeFrame: Measured post-intervention and at 6- and 12-month follow-ups
measure: Parenting stress
timeFrame: Measured post-intervention and at 6- and 12-month follow-ups
measure: Family functioning
timeFrame: Measured post-intervention and at 6- and 12-month follow-ups
measure: Consumer perspectives
timeFrame: Measured post-intervention and at 6- and 12-month follow-ups
measure: Cost of services
timeFrame: Measured post-intervention and at 6- and 12-month follow-ups
measure: Barriers to treatment
timeFrame: Measured post-intervention and at 6- and 12-month follow-ups
Other outcomes:
Locations:
city: Chelsea
country: United States
facility: MGH Chelsea Healthcare Center
state: Massachusetts
city: Dorchester
country: United States
facility: Codman Square Health Center
state: Massachusetts
city: Jamaica Plain
country: United States
facility: Martha Eliot Health Center
state: Massachusetts
city: Leominster
country: United States
facility: Medical Associates Pediatrics
state: Massachusetts
city: Southboro
country: United States
facility: Southboro Medical Group
state: Massachusetts
city: Westford
country: United States
facility: Pediatrics West
state: Massachusetts
city: Westwood
country: United States
facility: Westwood-Mansfield Pediatric Associates
state: Massachusetts
city: Wilmington
country: United States
facility: Wilmington Pediatrics
state: Massachusetts
city: Woburn
country: United States
facility: Woburn Pediatric Associates
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Ellen C. Perrin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tufts Medical Center
name: Christopher Sheldrick, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fitchburg State College
name: Jannette McMenamy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.