Behavior ProblemsNCT01085305
The Effectiveness of Parent-Child Interaction Therapy (PCIT)
A study testing Parent-Child Interaction Therapy and TAU in people with Behavior Problems and Oppositional Defiant Disorder, run by Norwegian University of Science and Technology at 2 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Behavior Problems, Oppositional Defiant Disorder, Conduct Disorder
- What is being tested?
- Parent-Child Interaction Therapy and TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 2 sitesNorway
- Study dates
- Sep 2006to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
barne- og ungdomspsykiatrisk klinikk, Helse Midt-Norge
Trondheim, Sør-trøndelag
Barne- og ungdomspsykiatrisk klinikk, Sør-Trøndelag
Trondheim, Trondheim, 7057
About this study
Official title: The Effectiveness of Parent-Child Interaction Therapy (PCIT) in Treating Behavior Problems in Young Children
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.
Read the 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.
- Being tested
- Parent-Child Interaction Therapy, TAU
- Keywords
- Behavior problems, Parent-Child Interaction, Locus of control, Psychiatric symptoms, Depressive symptoms, Attachment
- Medical subject headings
- Mental Disorders, Oppositional Defiant Disorder, Conduct Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-Child Interaction TherapyBehavioural
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.
TAUBehavioural
Usual treatment for behavioral disorders
| Study group | Role | What they receive |
|---|---|---|
| PCIT | Experimental | Provision of Parent-Child Interaction Therapy Receives: Behavioral: Parent-Child Interaction Therapy |
| TAU | Active comparator | Treatment as usual from other therapists in the same clinics Receives: Behavioral: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eyberg Child Behavior Inventory (ECBI)
ECBI is taken at study entry, after 6 months and after 18 months
Measured: Pre intervention, 6 months, 18 months
Secondary outcomes (6)
Dyadic Parent-Child Interaction Coding System (DPICS)
Parent-child interaction coded from standardized situations
Measured: Pre intervention, 6 months, 18 months
Parenting Stress Index
Number and degree of perceived stresses by parents
Measured: Pre intervention, 6 months, 18 months
Working Model of the Child Interview (WMCI)
Parents' attachment to the child
Measured: Pre intervention, 6 months, 18 months
Child Behavior Check List (CBCL)/Teacher Report Form (TRF)
Psychiatric symptoms as rated by parents and teachers, respectively
Measured: Pre intervention, 6 months, 18 months
Beck Depression Inventory (BDI)
Depressive symptoms in parents
Measured: Pre intervention, 6 months, 18 months
Parental Locus of Control - Short Form (PLOC-SF)
Parents' perceptions of internal versus external locus of control
Measured: Pre intervention, 6 months, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2010 (estimated)
- Study startSep 2006
- Primary completionJan 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Behavior ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Lars Wichstrøm, prof, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01085305
- Sponsor's protocol ID
- 4.2006.789
- Status last verified
- Sep 2016
- First submitted
- 10 Mar 2010
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27622458
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Parent-Child Interaction Therapy (PCIT) in Treating Behavior Problems in Young Children
- ClinicalTrials.gov ID
- NCT01085305
- Acronym / sponsor ID
- 4.2006.789
- Keywords
- Behavior problems, Parent-Child Interaction, Locus of control, Psychiatric symptoms, Depressive symptoms, Attachment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Sep 2006
- Primary completion
- Jan 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 11 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCIT | Experimental | Behavioral: Parent-Child Interaction TherapyProvision of Parent-Child Interaction Therapy |
| TAU | Active comparator | Behavioral: TAUTreatment as usual from other therapists in the same clinics |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent-Child Interaction TherapyParents 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. | Behavioural | PCIT |
| TAUUsual treatment for behavioral disorders | Behavioural | TAU |
Primary outcome
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
6 secondary outcomes
Dyadic Parent-Child Interaction Coding System (DPICS)
Time frame: Pre intervention, 6 months, 18 months
Parenting Stress Index
Time frame: Pre intervention, 6 months, 18 months
Working Model of the Child Interview (WMCI)
Time frame: Pre intervention, 6 months, 18 months
Child Behavior Check List (CBCL)/Teacher Report Form (TRF)
Time frame: Pre intervention, 6 months, 18 months
Beck Depression Inventory (BDI)
Time frame: Pre intervention, 6 months, 18 months
Parental Locus of Control - Short Form (PLOC-SF)
Time frame: Pre intervention, 6 months, 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
- Results publication: PubMed 27622458Bjorseth 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Wichstrøm, prof study director
Norwegian University of Science and Technology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent-Child Interaction Therapy and TAU in people with Behavior Problems and Oppositional Defiant Disorder, run by Norwegian University of Science and Technology at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eyberg Child Behavior Inventory (ECBI) (time frame: Pre intervention, 6 months, 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01085305, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2016.