The Effectiveness of Parent-Child Interaction Therapy (PCIT)

• ClinicalTrials.gov Identifier: NCT01085305
• Recruitment Status: Completed
• First Posted: March 11, 2010
• Last Update Posted: September 15, 2016
• Sponsor: Norwegian University of Science and Technology
• Collaborator: St. Olavs Hospital
• Information provided by (Responsible Party): Norwegian University of Science and Technology

Study Description

Brief Summary:

The purpose of this study was to investigate whether a type of parent-based intervention, Parent-Child Interaction Therapy will lower symptoms of behavior problems in young children more than treatment as usual.

Condition or disease	Intervention/treatment	Phase
Behavior Problems; Oppositional Defiant Disorder; Conduct Disorder	Behavioral: Parent-Child Interaction Therapy; Behavioral: TAU	Not Applicable

Detailed Description:

Behaviour problems, i.e. symptoms of oppositional defiant disorder (ODD) and conduct disorder (CD) are among the prevalent psychiatric disorders in children and one of the leading causes of help-seeking for mental health problems in children. There are several efficacious treatments for such problems in young children. However, most of these require that parents meet in groups. This is not always feasible. It is therefore a need to develop treatments that can deal with parents and families individually. Parent-Child Interaction Therapy (PCIT) is such an individually based treatment. Efficacy studies indicate symptom reduction greater that in treatment as usual (TAU). However, there is a need to study its effectiveness in ordinary clinical practise. This trial will study its effect in ordinary psychiatric clinics in the middle of Norway and compare it to the regular treatment (TAU) provided to young children with behavior problems in these clinics.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 63 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effectiveness of Parent-Child Interaction Therapy (PCIT) in Treating Behavior Problems in Young Children
• Study Start Date: September 2006
• Actual Primary Completion Date: January 2013
• Actual Study Completion Date: March 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: PCIT; Provision of Parent-Child Interaction Therapy	Behavioral: Parent-Child Interaction Therapy; Parents will be trained in interaction with their children in ways which foster non-hostility and cooperation in their children. By means of an ear-plug they will receive instruction on how to play and set limits for their child from their therapist who watches the interaction through a one-way mirror. Treatment is given until the parent masters these skill, which commonly takes 15-20 session of 1 hour.
Active Comparator: TAU; Treatment as usual from other therapists in the same clinics	Behavioral: TAU; Usual treatment for behavioral disorders

Outcome Measures

Primary Outcome Measures :

1. Eyberg Child Behavior Inventory (ECBI) [ Time Frame: Pre intervention, 6 months, 18 months ]
   ECBI is taken at study entry, after 6 months and after 18 months

Secondary Outcome Measures :

1. Dyadic Parent-Child Interaction Coding System (DPICS) [ Time Frame: Pre intervention, 6 months, 18 months ]
   Parent-child interaction coded from standardized situations
2. Parenting Stress Index [ Time Frame: Pre intervention, 6 months, 18 months ]
   Number and degree of perceived stresses by parents
3. Working Model of the Child Interview (WMCI) [ Time Frame: Pre intervention, 6 months, 18 months ]
   Parents' attachment to the child
4. Child Behavior Check List (CBCL)/Teacher Report Form (TRF) [ Time Frame: Pre intervention, 6 months, 18 months ]
   Psychiatric symptoms as rated by parents and teachers, respectively
5. Beck Depression Inventory (BDI) [ Time Frame: Pre intervention, 6 months, 18 months ]
   Depressive symptoms in parents
6. Parental Locus of Control - Short Form (PLOC-SF) [ Time Frame: Pre intervention, 6 months, 18 months ]
   Parents' perceptions of internal versus external locus of control

Eligibility Criteria

• Ages Eligible for Study: 2 Years to 7 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Referred to Child mental health specialty clinic for behavioral or attentional/hyperactive problems
• ECBI score of > 120
• 2 to 7 years of age
• Parental consent to the study

Exclusion Criteria:

• Psychosis or serious drug abuse in parents
• Lack of sufficient proficiency in Norwegian to fill in the questionnaires
• Mental retardation or pervasive developmental disorder in the child
• Suspicion of parental neglect or abuse of the child warranting a report to the child protection services

Contacts and Locations

Locations

Norway

barne- og ungdomspsykiatrisk klinikk, Helse Midt-Norge

Trondheim, Sør-trøndelag, Norway

Barne- og ungdomspsykiatrisk klinikk, Sør-Trøndelag

Trondheim, Norway, 7057

Sponsors and Collaborators

Norwegian University of Science and Technology

St. Olavs Hospital

Investigators

• Study Director: Lars Wichstrøm, prof; Norwegian University of Science and Technology

More Information

Publications of Results:

Bjørseth Å, Wichstrøm L. Effectiveness of Parent-Child Interaction Therapy (PCIT) in the Treatment of Young Children's Behavior Problems. A Randomized Controlled Study. PLoS One. 2016 Sep 13;11(9):e0159845. doi: 10.1371/journal.pone.0159845. eCollection 2016.

• Responsible Party: Norwegian University of Science and Technology
• ClinicalTrials.gov Identifier: NCT01085305
• Other Study ID Numbers: 4.2006.789
• First Posted: March 11, 2010
• Last Update Posted: September 15, 2016
• Last Verified: September 2016

Keywords provided by Norwegian University of Science and Technology:

Behavior problems; Parent-Child Interaction; Locus of control; Psychiatric symptoms; Depressive symptoms; Attachment

Additional relevant MeSH terms:

Disease; Problem Behavior; Conduct Disorder; Attention Deficit and Disruptive Behavior Disorders; Pathologic Processes; Behavioral Symptoms; Neurodevelopmental Disorders; Mental Disorders