NCT01085305

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 11, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

September 15, 2016

Status Verified

September 1, 2016

Enrollment Period

6.3 years

First QC Date

March 10, 2010

Last Update Submit

September 14, 2016

Conditions

Behavior ProblemsOppositional Defiant DisorderConduct Disorder

Keywords

Behavior problemsParent-Child InteractionLocus of controlPsychiatric symptomsDepressive symptomsAttachment

Outcome Measures

Primary Outcomes (1)

  • Eyberg Child Behavior Inventory (ECBI)

    ECBI is taken at study entry, after 6 months and after 18 months

    Pre intervention, 6 months, 18 months

Secondary Outcomes (6)

  • Dyadic Parent-Child Interaction Coding System (DPICS)

    Pre intervention, 6 months, 18 months

  • Parenting Stress Index

    Pre intervention, 6 months, 18 months

  • Working Model of the Child Interview (WMCI)

    Pre intervention, 6 months, 18 months

  • Child Behavior Check List (CBCL)/Teacher Report Form (TRF)

    Pre intervention, 6 months, 18 months

  • Beck Depression Inventory (BDI)

    Pre intervention, 6 months, 18 months

  • +1 more secondary outcomes

Study Arms (2)

PCIT

EXPERIMENTAL

Provision of Parent-Child Interaction Therapy

Behavioral: Parent-Child Interaction Therapy

TAU

ACTIVE COMPARATOR

Treatment as usual from other therapists in the same clinics

Behavioral: TAU

Interventions

Parent-Child Interaction TherapyBEHAVIORAL

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.

PCIT
TAUBEHAVIORAL

Usual treatment for behavioral disorders

TAU

Eligibility Criteria

Age2 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

barne- og ungdomspsykiatrisk klinikk, Helse Midt-Norge

Trondheim, Sør-trøndelag, Norway

Location

Barne- og ungdomspsykiatrisk klinikk, Sør-Trøndelag

Trondheim, Trondheim, 7057, Norway

Location

Related Publications (1)

  • Bjorseth A, Wichstrom 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.

    PMID: 27622458RESULT

MeSH Terms

Conditions

Mental DisordersOppositional Defiant DisorderConduct DisorderDepression

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersBehavioral SymptomsBehavior

Study Officials

  • Lars Wichstrøm, prof

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2010

First Posted

March 11, 2010

Study Start

September 1, 2006

Primary Completion

January 1, 2013

Study Completion

March 1, 2013

Last Updated

September 15, 2016

Record last verified: 2016-09

Locations

NO(2)