Evaluation of Tell Me More, a measurement feedback system in child and adolescent mental health outpatient clinic
| ISRCTN | ISRCTN90842243 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90842243 |
| Secondary identifying numbers | REK sør-øst (2018/1892-5) |
- Submission date
- 25/01/2019
- Registration date
- 21/02/2019
- Last edited
- 17/04/2020
- Recruitment status
- Suspended
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Measurement feedback systems (MFS) are solutions that grant patients and relatives the possibility to give information about symptoms, benefit of treatment or other information to their therapist and the institution responsible for the treatment. MFS has the potential to improve treatment by increasing patient and/or parent engagement in treatment, improved therapeutic alliance, better clinical outcome, and more effective services. The aim of this study is to investigate the feasibility of a MFS in a youth psychiatric outpatient clinic, the clinical effects of MFS use, and which components of the MFS are perceived as useful for the therapists.
Who can participate?
Children and youth who receive treatment at a Norwegian outpatient clinic
What does the study involve?
The MFS is gradually introduced by allowing new therapists access to the measurement feedback system every 6.weeks. Participants (patients and parents) are asked to answer a questionnaire before every meeting with their therapist and a 12-month follow-up questionnaire.
What are the possible benefits and risks of participating?
Participation may help to improve services for children and youth with psychological difficulties. Participants are requested to answer sensitive questions. Some might find this uncomfortable.
Where is the study run from?
The study is conducted by the Centre for Child and Adolescent Mental Health Eastern and Southern Norway. Participants are recruited at Nic Waals Institute, a child and youth outpatient clinic in Oslo, Norway.
When is the study starting and how long is it expected to run for?
Recruitment starts 01/05/2019, recruitment is planned to end 31/12/2020, and the study is planned to end 31/12/2021.
Who is funding the study?
Centre for Child and Adolescent Mental Health Eastern and Southern Norway and Lovisenberg Diakonale Hospital (Norway)
Who is the main contact?
Kristian Rognstad
kristian.rognstad@r-bup.no
Contact information
Scientific
Gullhaugveien 3-5
Oslo
0484
Norway
| Phone | +47 (0)41578950 |
|---|---|
| kristian.rognstad@r-bup.no |
Study information
| Study design | Single-centre stepped wedge cluster randomized trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Tell Me More - a randomized controlled trial of a measurement feedback system in a child and adolescent mental health outpatient clinic in Norway |
| Study acronym | Tell Me More |
| Study objectives | 1. The use of measurement feedback system (MFS) will result in greater symptom reduction, compared to treatment-as-usual. 2. The use of MFS will result in better therapeutic alliance, compared to treatment-as-usual. 3. The use of MFS will result in better client satisfaction, compared to treatment-as-usual. 4. Therapist's attitudes toward standardized assessment scales will predict use and perceived benefit of MFS. |
| Ethics approval(s) | Norwegian national research committees for medical and health research ethics (REK sør-øst), Gullhaugveien 1-3, 0484 Oslo, Tel: 22845511, Email: post@helseforskning.etikkom.no, 27/11/2018, ref: 2018/1892/REK sør-øst D |
| Health condition(s) or problem(s) studied | All mental disorders |
| Intervention | Randomization on therapist-level. Once a therapist is introduced to the active condition, all patients in the clinic allocated to this therapist will be in the active condition. Measurement feedback systems (MFS) are solutions that grant patients and relatives the possibility to give information about symptoms, benefit of treatment or other information to their therapist and the institution responsible for the treatment. MFS has the potential to improve treatment e.g. by increasing patient and/or parent engagement in treatment, improved therapeutic alliance, better clinical outcome, and more effective services. The active condition will be gradually introduced by allowing new therapists access to the measurement feedback system every 6 weeks. The trialists believe this will bolster implementation relative to the alternative of a "standard" parallel randomized controlled study. They plan to introduce the MFS over 10 steps, thus allowing for a full implementation of the MFS in the participating clinic within 1.5 years. The study will compare effects for patients with therapists that get access to MFS, with effects for patients with therapists that do not get access to MFS. Therapists with access to MFS will have bi-weekly discussion groups and be encouraged to use the feedback when discussing their active cases. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 1. Externalizing and internalizing problems measured using Behaviour and Feelings Survey (parent report) at baseline, at every meeting at the clinic throughout the patient’s treatment, and at follow up (12 months after baseline) 2. Externalizing and internalizing problems measured using Behaviour and Feelings Survey (self-report) at baseline, at every meeting at the clinic throughout the patient’s treatment, and at follow up (12 months after baseline) 3. Attainment of treatment goals measured using Top Problem Assessment (parent report) at baseline and at every meeting at the clinic throughout the patient’s treatment 4. Attainment of treatment goals measured using Top Problem Assessment (self-report) at baseline and at every meeting at the clinic throughout the patient’s treatment |
| Secondary outcome measures | 1. Sleep quality measured using one question about sleep quality over the last week (parent report) at baseline and at every meeting at the clinic throughout the patient’s treatment 2. Sleep quality measured using one question about sleep quality over the last week (self-report) at baseline and at every meeting at the clinic throughout the patient’s treatment 3. Food intake measured using one question about food intake over the last week (parent report) at baseline and at every meeting at the clinic throughout the patient’s treatment 4. Food intake measured using one question about food intake over the last week (self-report) at baseline and at every meeting at the clinic throughout the patient’s treatment 5. Externalizing and internalizing problems measured using Brief Problem Monitor (parent report) at baseline and follow up (12 months after baseline) 6. Externalizing and internalizing problems measured using Brief Problem Monitor (self-report) at baseline and follow up (12 months after baseline) |
| Overall study start date | 28/02/2018 |
| Completion date | 31/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 600 |
| Key inclusion criteria | 1. Youth, 5-18 years old 2. Granted right to treatment in Norwegian specialized mental health care |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/05/2019 |
| Date of final enrolment | 31/12/2020 |
Locations
Countries of recruitment
- Norway
Study participating centre
Oslo
0853
Norway
Sponsor information
Hospital/treatment centre
Postboks 4970 Nydalen
Oslo
0440
Norway
| Phone | +47 (0)23 22 50 00 |
|---|---|
| post@lds.no | |
| Website | https://www.lds.no/ |
"ROR" |
https://ror.org/03ym7ve89 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 15/04/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | A Norwegian protocol is available upon request (kristian.rognstad@r-bup.no). The trialists intend to publish a protocol through Trials during 2019. 2022: Effects of a MFS in a youth psychiatric outpatient clinic 2022: Feasibility of a MFS in a youth psychiatric outpatient clinic 2022: Components of MFS - what do therapists want? 2022: Therapist use of MFS - do therapist attitudes predict use and usefulness of MFS? |
| IPD sharing plan | Data will only be shared after a full dataset is obtained and the trialists have deleted the participant identification code key. The purpose of sharing the data is to ensure transparency in the research, use of the data for publication will depend on agreement with the owners of the data (RBUP). |
Editorial Notes
17/04/2020: Due to current public health guidance, recruitment for this study has been paused.
18/02/2019: Trial's existence confirmed by Norwegian national research committees for medical and health research ethics (REK sør-øst).
