Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Attention Deficit and Disruptive Behavior Disorders
  • Attention Deficit Disorder With Hyperactivity
  • Disease
  • Mental Disorders

NCT number NCT00402857
Study type Interventional
Source Tufts Medical Center
Contact
Status Completed
Phase Phase 3
Start date November 2006
Completion date December 2011

See also
  Status Clinical Trial Phase
Completed NCT00202605 - Safety and Efficacy of SPD465 in Adults With ADHD Phase 2
Not yet recruiting NCT02677519 - A 12-Month Open Label Safety Study of Aptensio XR® in Children Ages 4-5 Years Diagnosed With ADHD Phase 4
Completed NCT02730572 - Concerta (Methylphenidate) -To-Generic Switch Study N/A
Completed NCT01681082 - Psychological Effects of Tai Chi Training N/A
Active, not recruiting NCT01330693 - Cortical Excitability: Phenotype and Biomarker in Attention-deficit, Hyperactivity Disorder (ADHD) Therapy Phase 3
Completed NCT00830700 - Children's Attention Deficit Disorder With Hyperactivity (ADHD) Telemental Health Treatment Study N/A
Completed NCT00626236 - Phase 2a Study of Safety and Tolerability of SPN-810 in Children With ADHD and Persistent Serious Conduct Problems Phase 2
Completed NCT01012622 - An Efficacy and Safety Study of Osmotic Release Oral System (OROS) Methylphenidate in Participants With Attention Deficit Hyperactivity Disorder (ADHD) Phase 4
Completed NCT00598182 - Adherence and Long-term Effect of OROS Methylphenidate (CONCERTA): A Follow-up Study N/A
Completed NCT00381407 - Organizational Skills Training for Children With Attention Deficit Hyperactivity Disorder N/A
Completed NCT00178503 - Methylphenidate for Attention Deficit Hyperactivity Disorder and Autism in Children Phase 2/Phase 3
Completed NCT00247572 - Safety, Tolerability and Abuse Liability Study of Intravenous NRP104 in Adults With Stimulant Abuse Histories Phase 2
Completed NCT00118911 - Cognitive Behavioral Therapy for Treatment of Adult Attention Deficit Hyperactivity Disorder N/A
Completed NCT00557011 - NRP104, Adderall XR or Placebo in Children Aged 6-12 Years With ADHD Phase 2
Completed NCT00218322 - Effectiveness of ATMX in Treating Adolescents With ADHD and SUD Phase 4
Completed NCT00071656 - Psychosocial Treatment for Attention Deficit Hyperactivity Disorder (ADHD) Type I N/A
Active, not recruiting NCT00057668 - Preventing Behavior Problems in Children With ADHD Phase 2
Completed NCT00050050 - Cognitive Behavioral Therapy for Adult Attention Deficit Hyperactivity Disorder Phase 1
Completed NCT00050622 - Behavioral Treatment, Drug Treatment, and Combined Treatment for Attention Deficit Hyperactivity Disorder (ADHD) N/A
Completed NCT00031395 - Clonidine in Attention Deficit Hyperactivity Disorder (ADHD) in Children Phase 3