Condition category
Mental and Behavioural Disorders
Date applied
08/01/2016
Date assigned
08/02/2016
Last edited
08/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Mental health problems are common in both children and teenagers and approximately 50% of all adult mental health disorders begin in adolescence. In general, evidence-based psychotherapies (treatments) for patients in this age group has not been widely used in Norway. One possible reason for this is that these treatments are not considered either flexible and robust enough to meet the needs of youths in everyday clinical practice. In particular, comorbidity (i.e. other health issues) and changing problems and needs during treatment have been pointed out as obstacles for the use of evidence-based psychotherapies.The Modular Approach to Therapy for Children with Anxiety, Depression, Trauma or Conduct Problems (MATCH) is a training programme made up of a number of treatment modules that address different problems, including anxiety, depression, trauma-related symptoms and disruptive behaviour, as well as cater for co-morbidities. This study is looking at testing how effective MATCH is as helping children and adolescents with their mental health problems compared with those that receive the usual treatment. Long term effects of the treatment are also going to be investigated.

Who can participate?
Therapists at one of the seven child and Youth Psychiatric outpatient clinics taking part in this study. Patients taking part must be aged between 6 and 14 years old and referred to psychiatric treatment due to problems with depression, anxiety, trauma or behavioural issues.

What does the study involve?
Therapists are randomly allocated to one of two groups. Those in group 1 are given 5 days training in MATCH. They then treat their young patients using this programme. Therapists in group 2 are not given training in MATCH treat their patients as usual. Both children taking part in the study and their caretakers (for example, parents) are asked to fill in questionnaires that will help researchers assess their mental health before the therapy starts and then at 3, 6, 9, 12, 18 and 24 months after therapy starts.

What are the possible benefits and risks of participating?
This study could further researchers understanding of what helps youths suffering from anxiety, depression, trauma and/or behavioural problems. Participants might find it meaningful to contribute to this. However, the families that participate in the study will be offered therapy that is not sufficiently tested in Norway. It could be argued that there are ethical problems related to this. The researchers running this study also know very little about what "treatment as usual" actually consists of, and the observation data (video films of the therapy) will help them understand more of this. Another potential ethical dilemma is that responding to questionnaires, that are both rather time consuming and asking sensitive questions, may be a burden. The participants will receive a moderate economical compensation for the time spent answering questionnaires. They are also informed that all participation is voluntary and that they can withdraw from the study at any time. The participants that withdraw from the study will still continue receiving treatment for as long as the therapist considers it necessary/helpful.

Where is the study run from?
Seven child and youth psychiatric outpatient clinics in Norway.

When is the study starting and how long is it expected to run for?
January 2015 to September 2022

Who is funding the study?
The Norwegian Center for Child Behavioral Development

Who is the main contact?
1. Mr Kristian Eldjarn Rognstad (public)
kristian.rognstad@atferdssenteret.no
2. Mr John Kjøbli (scientific)
john.kjobli@atferdssenteret.no

Trial website

Contact information

Type

Public

Primary contact

Mr Kristian Eldjarn Rognstad

ORCID ID

Contact details

Postboks 7053 Majorstuen
Oslo
0306
Norway
0047 415 78 950
kristian.rognstad@atferdssenteret.no

Type

Scientific

Additional contact

Mr John Kjøbli

ORCID ID

Contact details

Postboks 7053 Majorstuen
Oslo
0306
Norway
0047 936 60 252
john.kjobli@atferdssenteret.no

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomized controlled effectiveness study of modular approach to therapy for children with anxiety, depression, trauma and conduct problems (MATCH).

Acronym

Study hypothesis

1. We will investigate whether participants in the MATCH group will have a larger reduction in internalization and externalization problems compared to the treatment as usual group at the end of treatment
2. We will investigate whether participants in the MATCH group will have a more rapid reduction in internalization and externalization problems compared to the treatment as usual group.
3. We will investigate whether participants in the MATCH group will have a larger reduction in internalization and externalization problems compared to the treatment as usual group at follow-up (2 years after start of therapy)

Ethics approval

Regional committees for medical and health research ethics, 03/08/2015, ref: 2015/633-1


Study design

Multi-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Depression, anxiety, trauma and conduct problems in young people and children

Intervention

1. Modular approach to therapy for children with depression, anxiety, trauma and conduct problems (MATCH)
Therapists will be given a manual, trained and follow consultation in MATCH. They will receive 5 days of training in MATCH and will after starting their first study cases have weekly Skype/Lync consultation sessions with a MATCH trainer. This is a modular approach to therapy for children which consists of modules from cognitive behavioral therapy and parental training. MATCH was specifically designed to combine the effective elements of the evidence based therapies (EBTs) for anxiety, depression, trauma-related symptoms and disruptive behaviour in one protocol, cater for co-morbidity and provide an opportunity to address different disorders that may emerge during therapy. A web based system (PATH) will provide the therapists with weekly data on changes in the severity of the patients problems, which will guide the therapists choice of modules for subsequent sessions. All sessions are done face-to-face and are one-on-one with the child or his/her family.

2. Treatment as usual
Any therapist who is not trained in MATCH and is currently working in the Child and Youth Psychiatric clinics (Barne- og ungdomspsykiatriske klinikker) used in the study will be able to provide control cases.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Youth Self-Report Form (YSR). This is a child-report measure that assesses problem behaviors, and that provides scales for internalizing and externalizing problems. It also scores eight empirically based syndromes and DSM-oriented scales, and provides a summary of total problems. Measured before therapy starts, and 3, 6, 9, 12, 18 and 24 month after therapy starts.
2. Child Behavior Checklist (CBCL). This is a parallel form to the YSR where caretakers are the respondents. Measured before therapy starts, and 3, 6, 9, 12, 18 and 24 month after therapy starts.

Every week during therapy the participants and their parents will answer a mail survey including:
1. Top problems assessment: rating of the severity of three "top problems" which are defined by the participant at the start of therapy.
2. Behavior and emotions survey – child: Child self report of behavior and emotions/thoughts (measure of internalizing and externalizing problems)
3. Behavior and emotions survey – parent: Parent report on child's behavior and emotions/thoughts (measure of internalizing and externalizing problems)

Secondary outcome measures

1. Use of other services and medication. This will be measured with a questionnaire inspired by Service Assessment for Children and Adolecents (SACA). The items in this version are chosen so that they would span most of the therapeutic and pedagogical services a child/adolescent in Norway could be offered.

Potential moderators and mediators:
1. Action and Acceptance Questionnaire (parent)
2. SCL5 (parent)
3. Observational data (all therapy sessions will be filmed, and a random selection of these will be rated to obtain a measure of fidelity and therapist/client-alliance)
4. Therapist background
5. Implementation

Overall trial start date

01/01/2015

Overall trial end date

01/09/2022

Reason abandoned

Eligibility

Participant inclusion criteria

1. From 6 to 14 years
2. Referred to psychiatric treatment due to problems with depression, anxiety, trauma or conduct.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

280

Participant exclusion criteria

1. Psychosis, intellectual disability, pervasive developmental disorder, anorexia, bulimia or having conducted sexual abuse.
2. Acute suicidality, or suicide attempt within the past 12 months.
3. Referred to psychiatric treatment solely due to inattention and/or hyperactivity.
4. Repeated and grave antisocial and criminal behavior (e.g. serious treats to hurt others, vandalism, burglary, or violence).
5. Substance abuse as primary problem

Recruitment start date

15/01/2016

Recruitment end date

01/09/2020

Locations

Countries of recruitment

Norway

Trial participating centre

Child and Youth Psychiatric outpatient clinic - Follo
Ski
Akershus
1400
Norway

Trial participating centre

Child and Youth Psychiatric outpatient clinic - Øvre Romerike
2050
Norway

Trial participating centre

Child and Youth Psychiatric outpatient clinic - Hamar
2321
Norway

Trial participating centre

Child and Youth Psychiatric outpatient clinic - Voss
5700
Norway

Trial participating centre

Child and Youth Psychiatric outpatient clinic - Nordhordaland
5914
Norway

Trial participating centre

Child and Youth Psychiatric outpatient clinic - Bergen Sentrum
5021
Norway

Trial participating centre

Child and Youth Psychiatric outpatient clinic - Ytrebygda
5221
Norway

Sponsor information

Organisation

The Norwegian Center for Child Behavioral Development (Atferdssenteret)

Sponsor details

Postboks 7053 Majorstuen
Oslo
0306
Norway
0047 23 20 58 00
post@atferdssenteret.no

Sponsor type

Research organisation

Website

http://www.atferdssenteret.no/

Funders

Funder type

Hospital/treatment centre

Funder name

The Norwegian Center for Child Behavioral Development

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Approximate publication plan is below:
2018: A Randomized Effectiveness Trial of Modular Approach to Therapy for Children (MATCH): Immediate outcomes
2019: A Randomized Effectiveness Trial of Modular Approach to Therapy for Children (MATCH): 2-year Follow-Up after intake
2019-2020: Effects of Modular Approach to Therapy for Children (MATCH) – moderators and mediators (implementation, fidelity, family background, etc.)

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes