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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01085305
Other study ID # 4.2006.789
Secondary ID
Status Completed
Phase N/A
First received March 10, 2010
Last updated September 14, 2016
Start date September 2006
Est. completion date March 2013

Study information

Verified date September 2016
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority Norway: Data Protection Authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date March 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 7 Years
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

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.
TAU
Usual treatment for behavioral disorders

Locations

Country Name City State
Norway barne- og ungdomspsykiatrisk klinikk, Helse Midt-Norge Trondheim Sør-trøndelag
Norway Barne- og ungdomspsykiatrisk klinikk, Sør-Trøndelag Trondheim

Sponsors (2)

Lead Sponsor Collaborator
Norwegian University of Science and Technology St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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 2 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Eyberg Child Behavior Inventory (ECBI) ECBI is taken at study entry, after 6 months and after 18 months Pre intervention, 6 months, 18 months No
Secondary Dyadic Parent-Child Interaction Coding System (DPICS) Parent-child interaction coded from standardized situations Pre intervention, 6 months, 18 months No
Secondary Parenting Stress Index Number and degree of perceived stresses by parents Pre intervention, 6 months, 18 months No
Secondary Working Model of the Child Interview (WMCI) Parents' attachment to the child Pre intervention, 6 months, 18 months No
Secondary Child Behavior Check List (CBCL)/Teacher Report Form (TRF) Psychiatric symptoms as rated by parents and teachers, respectively Pre intervention, 6 months, 18 months No
Secondary Beck Depression Inventory (BDI) Depressive symptoms in parents Pre intervention, 6 months, 18 months No
Secondary Parental Locus of Control - Short Form (PLOC-SF) Parents' perceptions of internal versus external locus of control Pre intervention, 6 months, 18 months No
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