|- candidate number||5530|
|- NTR Number||NTR1743|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||31-mrt-2009|
|- Secondary IDs||80-82435-98-8053 ZonMw|
|- Public Title||Effectiveness of Parent-Child Interaction Therapy (PCIT) compared with Creative Family Therapy.|
|- Scientific Title||A randomized controlled trial (RCT) to study the effects of Parent-Child Interaction Therapy versus Creative Family Therapy on young children's disruptive behaviors and their parents.|
|- hypothesis||The main objectives of the present study are: determining short and long term effects of PCIT and Creative Family Therapy; assessing the efficiency of these therapies; and identifying the characteristics of those children and parents who do not respond to the given treatment.|
|- Healt Condition(s) or Problem(s) studied||Emotional problems in children, Disruptive behavior , Antisocial behaviour, Parent-child interaction problems, Family problems|
|- Inclusion criteria||1. The child's age is between 2 and 7 years;|
2. The child displays disruptive behavior;
3. Dutch or English speaking parents.
|- Exclusion criteria||1. A severy sensory or mental impairment e.g., deafness, autism, mental retardation;|
2. Another or simultaneous psychosocial treatment;
3. Parents with severe substance abuse problems.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2009|
|- planned closingdate||1-nov-2012|
|- Target number of participants||100|
Parent-Child Interaction Therapy is an individualized intervention developed for caregivers and their 2- to 7-year-old children with disruptive and externalizing behavior. PCIT teaches authoritative parenting, a combination of nurturance, good communication and firm control in two phases of treatment. In the first phase, called the child-directed interaction (CDI) phase, parent learn skills to strengthen the parent-child bond, increase child prosocial behavior and decrease negative child behavior. In the second phase, called the parent-directed interaction (PDI), parents learn additional skills to reduce child non-compliance and other negative behaviors that show resistance to extinction in the child phase.
Creative family therapy:
This treatment focuses on positive changes in the interaction patterns of family members. Siblings can be involved in treatment too. Parents and children are working together on a creative task. Parents form their own treatment goals. The therapist creates a task adjusted on this goals. In this treatment parents learn to lead their children in a successful way.
|- Primary outcome||1. Decrease of the level of disruptive behavior;|
2. Decrease of the level of parenting stress;
3. Improve parenting skills;
4. Improve the parent-child relationship.
|- Secondary outcome||This study will also examine which parents and children could benefit the most from which treatment.|
|- Timepoints||The study contains three measurements:|
1. Prior to treatment;
2. Directly after treatment;
3. Six months after treatment.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| MariŽlle Abrahamse|
|- CONTACT for SCIENTIFIC QUERIES||Dr. R.J.L. Lindauer|
|- Sponsor/Initiator ||University of Twente, Faculty Management & Governance |
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Most important predictor of adult antisocial behavior is the occurrence of problems during early childhood. Disruptive behavior of children over 8 years of age might become chronic and becomes difficult to change. An early intervention is important for these children. Thereby it is important to treat disruptive behavior in children and to support parents for preventing antisocial behavior.
Parent-Child Interaction Therapy (PCIT) is a treatment aimed for children between the ages of 2 and 7 with disruptive behavior. PCIT is designed in the USA and is implemented in the Netherlands at The Bascule since 2007. The Creative Family is designed in the Netherlands by Frans Beelen and is targeting the same population.
Unlike in some foreign countries, in the Netherlands there is little knowledge about treatment effects of PCIT and Creative Family Therapy. The aim of this study is the assess the efficiency of PCIT compared to the Creative Family Therapy.
|- Main changes (audit trail)|
|- RECORD||31-mrt-2009 - 10-jun-2010|