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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH076244 | U.S. NIH Grant/Contract | View source | |
| DSIR CT-C |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Participants will receive the Incredible Years Program, a group parenting intervention |
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| 2 | Other | Participants assigned to the waitlist condition will receive the Incredible Years Program after a 1-year waiting period |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Incredible Years Program | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Parenting behavior | Measured post-intervention and at 6- and 12-month follow-ups | |
| Child disruptive behaviors | Measured post-intervention and at 6- and 12-month follow-ups |
| Measure | Description | Time Frame |
|---|---|---|
| Child and parent functional status/impairment | Measured post-intervention and at 6- and 12-month follow-ups | |
| Parenting stress | Measured post-intervention and at 6- and 12-month follow-ups | |
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Inclusion Criteria:
Parent or primary caregiver of a child who fits the following criteria:
Exclusion Criteria:
Parent or primary caregiver of a child who fits the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ellen C. Perrin, MD | Tufts Medical Center | Principal Investigator |
| Christopher Sheldrick, PhD | Tufts Medical Center | Principal Investigator |
| Jannette McMenamy, PhD | Fitchburg State College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MGH Chelsea Healthcare Center | Chelsea | Massachusetts | United States | |||
| Codman Square Health Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24190691 | Derived | 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. |
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| Family functioning |
| Measured post-intervention and at 6- and 12-month follow-ups |
| Consumer perspectives | Measured post-intervention and at 6- and 12-month follow-ups |
| Cost of services | Measured post-intervention and at 6- and 12-month follow-ups |
| Barriers to treatment | Measured post-intervention and at 6- and 12-month follow-ups |
| Dorchester |
| Massachusetts |
| 02124 |
| United States |
| Martha Eliot Health Center | Jamaica Plain | Massachusetts | 02130 | United States |
| Medical Associates Pediatrics | Leominster | Massachusetts | 01453 | United States |
| Southboro Medical Group | Southborough | Massachusetts | 01772 | United States |
| Pediatrics West | Westford | Massachusetts | 01886 | United States |
| Westwood-Mansfield Pediatric Associates | Westwood | Massachusetts | 02090 | United States |
| Wilmington Pediatrics | Wilmington | Massachusetts | 01887 | United States |
| Woburn Pediatric Associates | Woburn | Massachusetts | 01801 | United States |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D000096865 | Oppositional Defiant Disorder |
| ID | Term |
|---|---|
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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