Behavior ProblemNCT05581914
Effectiveness of the MY LIFE Treatment for Adolescents With Behavioral Problems
A study testing MY LIFE treatment and Care as Usual in people with Behavior Problem, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
Objective This study examines the effects of the MY LIFE treatment, a group intervention aiming to increase hope, self-worth and social support seeking in adolescents with behavioral problems in mental health care. Read more about this study
- Who is it for?
- Ages 14 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior Problem
- What is being tested?
- MY LIFE treatment and Care as Usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Oct 2022to Feb 2024
- 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 14 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescent is referred for behavioral problems
Who cannot join
- School level is below BL (a school level in the Dutch school system)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Levvel
Amsterdam, North Holland, 1076EC
YCJ Bors, MSc, 0681150022, y.bors@levvel.nl
About this study
Official title: The Effectiveness of the MY LIFE Treatment for Adolescents With Behavioral Problems: a Group Randomized Controlled Trial and Qualitative Analyses of Client Evaluations.
Objective This study examines the effects of the MY LIFE treatment, a group intervention aiming to increase hope, self-worth and social support seeking in adolescents with behavioral problems in mental health care.
Method This study is a group randomized controlled trial to determine whether MY LIFE is effective, by comparing care as usual with care as usual plus the MY LIFE treatment. Groups of adolescents (N= 50 per arm, Age= 14-20) with behavioral problems will be randomly assigned to either the care as usual condition or the care as usual plus the MY LIFE treatment condition. The second part of the study is focused on the subjective evaluation of the intervention by the adolescents, using qualitative research methods.
Results Primary outcomes of the RCT are hope, self-worth, and seeking social support. As secondary outcomes emotional and behavioral symptoms are assessed. The second part of the study analyses the subjective evaluation of the MY LIFE treatment.
Read the detailed description
Treating adolescents with behavioral problems without motivation for change in youth mental healthcare is a challenge, and group interventions targeting these adolescents show low effectiveness. This seems even more pronounced in girls. Most interventions focus on behavioral change and include parental involvement. The MY LIFE treatment was designed to provide a treatment based on the needs of adolescents. A good working alliance is essential in treatment. For instance, the alliance between girls and staff in residential care, predicts treatment success, and a weak working alliance is associated with more behavioral problems. According to evaluations of successful treatments at our mental health department for complex behavioral problems, adolescents value the concepts of hope, self-worth and seeking support as well. Therefore, these concepts, as well as the working alliance, were key elements in the development of the MY LIFE treatment.
Hope This study uses Snyder's definition: "hope is a positive motivational state that is based on an interactively derived sense of successful (a) agency (goal-directed energy) and (b) pathways (planning to meet goals)" . The relevance of the concept of hope for adolescents with mental health problems has been widely studied. For instance, hope makes children resilient to adverse life events. The prevalence of adverse life events is high in children and adolescents with behavioral problems, which emphasizes the importance of addressing this concept in interventions for these adolescents.
Self-worth In this study self-worth is defined as a person's subjective evaluation of his or hers own worth. Low self-worth is related to aggression and antisocial behavior, and addressing this concept in the treatment of behavioral problems of adolescents may help to reduce aggressive and antisocial behavior.
Seeking support The definition of seeking support used here, is "having an active coping style when facing problems or stressful situations" . An active coping style leads to a greater well-being in adolescents. Therefore, teaching them an active coping style, such as seeking support, is important in an attempt to reduce behavioral problems and to foster well-being in adolescents witt behavioral problems. These findings suggest coping should be a target for intervention.
These three concepts are interrelated; active coping such as seeking support is related to more self-worth and vice versa: better social relationships lead to more self-worth. Furthermore, studies show that self- worth mediates the association of hope with life satisfaction.
Objectives and research questions
The study aims to examine the effectiveness of the MY LIFE treatment, answering the following questions:
- Do adolescents with behavioral problems (age 14-20) receiving MY LIFE in addition to care as usual, have more hope after the treatment, compared to the adolescents in the waitinglist control group receiving only care as usual?
- Do adolescents with behavioral problems (age 14-20) receiving MY LIFE in addition to care as usual have a higher level of self-worth after the treatment, compared to the waitinglist control group receiving only care as usual?
- Do adolescents with behavioral problems (age 14-20) receiving MY LIFE in addition to care as usual seek more support after the treatment compared to the waitinglist control group receiving only care as usual?
- Do adolescents with behavioral problems (age 14-20) have more hope, a higher level of self-worth and seek more support after receiving MY LIFE, in comparison to pre-treatment? Secondary, this study focuses on the question:
- Is there a change in behavioral and emotional symptoms (emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, prosocial behavior, disruptive behavior, anger) in adolescents with behavioral problems (age 14-20) receiving MY LIFE in addition to care as usual, as compared to adolescents in the waitinglist control group receiving only care as usual? The second part of this study uses a structured interview to assess the subjective evaluation of the treatment by the adolescents.
Method Trial management The trial is funded by KFZ-J (Kwaliteit Forensische Zorg Jeugd) and led by a team of researchers and clinicians from the AmsterdamUMC and Levvel (youth mental health care).
Study design The study is a group randomized controlled trial, comparing Care As Usual (CAU) plus the MY LIFE treatment with a waitinglist control group receiving only CAU. The study procedure is depicted in figure 1. All adolescents and a chosen caretaker (CC) by the adolescent, will fill in questionnaires during a baseline assessment (T0). Six weeks later all adolescents and the CC will again fill in questionnaires during a post-measurement (T1). The waitinglist control group will receive the MY LIFE treatment after T1 and an additional post-measurement will be done after they have received the treatment (T2). All adolescents will be asked to fill in the questionnaires again 1 year after T0 (T3).
The Medical Ethics Review Committee of VU University Medical Center (METC) has reviewed the study protocol and concluded that the Medical Research Involving Human Subjects Act (WMO) does not apply to this study. The Medical Ethics Review Committee of VU University Medical Center is registered with the US Office for Human Research Protections (OHRP) as IRB00002991. The FWA number assigned to VU University Medical Center is FWA00017598.
Data management Since this is the first study on the MY LIFE treatment, and this treatment is different than interventions used in this population, it is difficult to estimate the expected effect and also the required sample size. Furthermore, previous studies in similar populations have demonstrated a large variety in effectsized of CBT-based interventions, ranging from small (d=0.33) to large (d=0.98) effects. To calculate the sample size for this study we used G* Power, with an estimation effect of (d=0.5), a power of β=0.8 and an ICC=0.6 to correct for dependency between the repeated measures. This resulted in an N of 50 adolescents per arm (in total N= 100) for this RCT.
A group randomized controlled trial will be performed to evaluate the effect of the intervention. All groups will receive care as usual within their youth care facility. The treatment group will also receive the MY LIFE treatment. Castor, a data management software program, will be used to store the data. To analyse the data a multilevel model with a three level structure (repeated measures are clustered within participants, and participants are clustered within groups) will be used via SPSS (Statistical Package for the Social Sciences). Analyses will be performed twice: once based on intention-to-treat (we consider this our primary analysis), and once including only those adolescents who completed the intervention. Missing data is taken into account by the multilevel analyses. Outliers deviating 3SD from the mean will be excluded.
The qualitative data will be analysed using ATLAS.ti.
- Conditions
- Behavior Problem
- Being tested
- MY LIFE treatment, Care as Usual
- Keywords
- Behavioral problems, Transdiagnostic treatment, Adolescents, Self-worth, Hope, Seeking support, Peer expert
- Medical subject headings
- Mental Disorders, Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MY LIFE treatmentOther
The MY LIFE is a group treatment consisting of 5 workshops, for adolescents with a low motivation for mental health treatment. It aims to increase self- worth, hope for the future and seeking social support through exercises by using music and lyrics and other creative exercises to engage adolescents. The MY LIFE treatment also uses methods that stem from psychodynamic, cognitive behavioral, and solution focused theories. The therapeutic attitude is based on client-centered therapy of Rogers, which includes a genuine, positive regard and empathic understanding, focusing on the inner strength and growth potential of a person. Adolescents are never forced to participate during the workshops, merely encouraged.
The core of the treatment is: the adolescent decides
Care as UsualOther
The care as usual the adolescents receives
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Care as Usual and the MY LIFE treatment Receives: Other: MY LIFE treatment |
| Waitinglist Control group | Active comparator | Care as Usual Receives: Other: Care as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
JIJ questionnaire
Hope/ Self-worth/ Seeking support Self report
Measured: For the Treatment arm: at the first intake, 7 weeks after the intake, one year after the intake. For the waiting list control group: at the intake, 7 weeks after intake, 7 weeks later after treatment, one year after intake
CHS (Children Hope Scale)
Hope Self report
Measured: For the Treatment arm: at the first intake, 7 weeks after the intake, one year after the intake. For the waiting list control group: at the intake, 7 weeks after intake, 7 weeks later after treatment, one year after intake
BSCI-Y (Beck Self- Concept Inventory for Youth)
Self-worth Self report
Measured: For the Treatment arm: at the first intake, 7 weeks after the intake, one year after the intake. For the waiting list control group: at the intake, 7 weeks after intake, 7 weeks later after treatment, one year after intake
UCL (S) Utrechtse Coping List Social support
Seeking support Self Report
Measured: For the Treatment arm: at the first intake, 7 weeks after the intake, one year after the intake. For the waiting list control group: at the intake, 7 weeks after intake, 7 weeks later after treatment, one year after intake
JIJ questionnaire BA
Hope/ Self -worth/ Seeking support. Form is filled in by a caregiver chosen by the adolescent.
Measured: For the Treatment arm: at the first intake, 7 weeks after the intake. For the waiting list control group: at the intake, 7 weeks after intake, 7 weeks later after treatment.
KLAD (Klachtenlijst Adolescenten) subscale self-worth
Self- Worth Form is filled in by caregiver chosen by the adolescent.
Measured: For the Treatment arm: at the first intake, 7 weeks after the intake. For the waiting list control group: at the intake, 7 weeks after intake, 7 weeks later after treatment.
KLAD (Klachtenlijst Adolescenten) subscale social support
Seeking support Form is filled in by caregiver chosen by the adolescent
Measured: For the Treatment arm: at the first intake, 7 weeks after the intake. For the waiting list control group: at the intake, 7 weeks after intake, 7 weeks later after treatment.
Secondary outcomes (6)
SDQ (Strengths and Difficulties Questionnaire)
Emotional symptoms Conduct problems Hyperactivity/inattention Peer relationship problems Prosocial behavior Self report
Measured: For the Treatment arm: at the first intake, 7 weeks after the intake. For the waiting list control group: at the intake, 7 weeks after intake, 7 weeks later after treatment.
BDBI-Y (Beck Disruptive Behavior Inventory for Youth)
Disruptive behavior self report
Measured: For the Treatment arm: at the first intake, 7 weeks after the intake, one year after the intake. For the waiting list control group: at the intake, 7 weeks after intake, 7 weeks later after treatment, one year after intake
BANI-Y (Beck Anger Inventory for Youth)
Anger self report
Measured: For the Treatment arm: at the first intake, 7 weeks after the intake, one year after the intake. For the waiting list control group: at the intake, 7 weeks after intake, 7 weeks later after treatment, one year after intake
Workshop evaluation designed for the purpose of this study
Client satisfaction regarding workshop with three smilies. Self report
Measured: per workshop so every week during the treatment, 5 times
Strengths and Difficulties Questionnaire (SDQ) for parents or teachers
Emotional symptoms, Conduct problems, Hyperactivity/Inattention, Peer relationship problems, Prosocial behavior
Measured: For the Treatment arm: at the first intake, 7 weeks after the intake. For the waiting list control group: at the intake, 7 weeks after intake, 7 weeks later after treatment.
KLAD (Klachtenlijst Adolescenten) subscale emotional difficulties
Emotional difficulties. Form is filled in by a caregiver chosen by the adolescent
Measured: For the Treatment arm: at the first intake, 7 weeks after the intake. For the waiting list control group: at the intake, 7 weeks after intake, 7 weeks later after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start6 Oct 2022
- Primary completionDec 2023 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Behavior ProblemStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helena Oldenhof, Amsterdam UMC, location VUmc
- Investigators
- T.J. Dekkers, PhD, Study chair, AmsterdamUMCJ.W.R. Twisk, Prof.Dr, Study chair, AmsterdamUMCA. Popma, Prof.Dr, Study director, AmsterdamUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05581914
- Sponsor's protocol ID
- RCT MY LIFE
- Status last verified
- Oct 2022
- First submitted
- 5 Oct 2022
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing of data after the study. Merely for use in this particular study.
Publications
Ayotte, M. H., Lanctôt, N., & Tourigny, M. (2016). How the working alliance with adolescent girls in residential care predicts the trajectories of their behavior problems. Residential Treatment for Children & Youth, 33(2), 135-154. https://doi.org/10.1080/0886571x.2016.1175994
Barendregt CS, Van der Laan AM, Bongers IL, Van Nieuwenhuizen C. Adolescents in secure residential care: the role of active and passive coping on general well-being and self-esteem. Eur Child Adolesc Psychiatry. 2015 Jul;24(7):845-54. doi: 10.1007/s00787-014-0629-5. Epub 2014 Oct 18.
PubMed 25325990Barendregt CS, van der Laan AM, Bongers IL, van Nieuwenhuizen C. Longitudinal Relation Between General Well-Being and Self-Esteem. Int J Offender Ther Comp Criminol. 2016 Dec;60(16):1836-1855. doi: 10.1177/0306624X15588773. Epub 2016 Jul 28.
PubMed 26063543Baxter MA, Hemming EJ, McIntosh HC, Hellman CM. Exploring the Relationship Between Adverse Childhood Experiences and Hope. J Child Sex Abus. 2017 Nov-Dec;26(8):948-956. doi: 10.1080/10538712.2017.1365319. Epub 2017 Aug 31.
PubMed 28857691Boeije, H. (2016). Analyseren in kwalitatief onderzoek: Denken en doen. Boom Lemma.
Dam, C. V., Nijhof, K. S., Scholte, R. H. J., & Veerman, J. W. (2010). Evaluatie nieuw zorgaanbod: Gesloten jeugdzorg voor jongeren met ernstige gedragsproblemen: Eindrapport
Donnellan MB, Trzesniewski KH, Robins RW, Moffitt TE, Caspi A. Low self-esteem is related to aggression, antisocial behavior, and delinquency. Psychol Sci. 2005 Apr;16(4):328-35. doi: 10.1111/j.0956-7976.2005.01535.x.
PubMed 15828981Du, H., Bernardo, A. B., & Yeung, S. S. (2015). Locus-of-hope and life satisfaction: The mediating roles of personal self-esteem and relational self-esteem. Personality and Individual Differences, 83, 228-233. https://doi.org/10.1016/j.paid.2015.04.026
Frydenberg E, Lewis R. Relations among well-being, avoidant coping, and active coping in a large sample of Australian adolescents. Psychol Rep. 2009 Jun;104(3):745-58. doi: 10.2466/PR0.104.3.745-758.
PubMed 19708401Granski M, Javdani S, Anderson VR, Caires R. A Meta-Analysis of Program Characteristics for Youth with Disruptive Behavior Problems: The Moderating Role of Program Format and Youth Gender. Am J Community Psychol. 2020 Mar;65(1-2):201-222. doi: 10.1002/ajcp.12377. Epub 2019 Aug 26.
PubMed 31449683Harris MA, Orth U. The link between self-esteem and social relationships: A meta-analysis of longitudinal studies. J Pers Soc Psychol. 2020 Dec;119(6):1459-1477. doi: 10.1037/pspp0000265. Epub 2019 Sep 26.
PubMed 31556680Horvath AO, Luborsky L. The role of the therapeutic alliance in psychotherapy. J Consult Clin Psychol. 1993 Aug;61(4):561-73. doi: 10.1037//0022-006x.61.4.561.
PubMed 8370852McLeod BD. Relation of the alliance with outcomes in youth psychotherapy: a meta-analysis. Clin Psychol Rev. 2011 Jun;31(4):603-16. doi: 10.1016/j.cpr.2011.02.001. Epub 2011 Mar 17.
PubMed 21482319Muarifah A, Mashar R, Hashim IHM, Rofiah NH, Oktaviani F. Aggression in Adolescents: The Role of Mother-Child Attachment and Self-Esteem. Behav Sci (Basel). 2022 May 17;12(5):147. doi: 10.3390/bs12050147.
PubMed 35621444Peeters, J. (1994). Klachtenlijst voor adolescenten: KLAD (Complaintlist for Adolescents). Gedragstherapie, 27(2), 109-125.
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the MY LIFE Treatment for Adolescents With Behavioral Problems: a Group Randomized Controlled Trial and Qualitative Analyses of Client Evaluations.
- ClinicalTrials.gov ID
- NCT05581914
- Acronym / sponsor ID
- RCT MY LIFE
- Conditions
- Behavior Problem
- Keywords
- Behavioral problems, Transdiagnostic treatment, Adolescents, Self-worth, Hope, Seeking support, Peer expert
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 17 Oct 2022 (actual)
- 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.
Objective This study examines the effects of the MY LIFE treatment, a group intervention aiming to increase hope, self-worth and social support seeking in adolescents with behavioral problems in mental health care.
Method This study is a group randomized controlled trial to determine whether MY LIFE is effective, by comparing care as usual with care as usual plus the MY LIFE treatment. Groups of adolescents (N= 50 per arm, Age= 14-20) with behavioral problems will be randomly assigned to either the care as usual condition or the care as usual plus the MY LIFE treatment condition. The second part of the study is focused on the subjective evaluation of the intervention by the adolescents, using qualitative research methods.
Results Primary outcomes of the RCT are hope, self-worth, and seeking social support. As secondary outcomes emotional and behavioral symptoms are assessed. The second part of the study analyses the subjective evaluation of the MY LIFE treatment.
Detailed description
Treating adolescents with behavioral problems without motivation for change in youth mental healthcare is a challenge, and group interventions targeting these adolescents show low effectiveness. This seems even more pronounced in girls. Most interventions focus on behavioral change and include parental involvement. The MY LIFE treatment was designed to provide a treatment based on the needs of adolescents. A good working alliance is essential in treatment. For instance, the alliance between girls and staff in residential care, predicts treatment success, and a weak working alliance is associated with more behavioral problems. According to evaluations of successful treatments at our mental health department for complex behavioral problems, adolescents value the concepts of hope, self-worth and seeking support as well. Therefore, these concepts, as well as the working alliance, were key elements in the development of the MY LIFE treatment.
Hope This study uses Snyder's definition: "hope is a positive motivational state that is based on an interactively derived sense of successful (a) agency (goal-directed energy) and (b) pathways (planning to meet goals)" . The relevance of the concept of hope for adolescents with mental health problems has been widely studied. For instance, hope makes children resilient to adverse life events. The prevalence of adverse life events is high in children and adolescents with behavioral problems, which emphasizes the importance of addressing this concept in interventions for these adolescents.
Self-worth In this study self-worth is defined as a person's subjective evaluation of his or hers own worth. Low self-worth is related to aggression and antisocial behavior, and addressing this concept in the treatment of behavioral problems of adolescents may help to reduce aggressive and antisocial behavior.
Seeking support The definition of seeking support used here, is "having an active coping style when facing problems or stressful situations" . An active coping style leads to a greater well-being in adolescents. Therefore, teaching them an active coping style, such as seeking support, is important in an attempt to reduce behavioral problems and to foster well-being in adolescents witt behavioral problems. These findings suggest coping should be a target for intervention.
These three concepts are interrelated; active coping such as seeking support is related to more self-worth and vice versa: better social relationships lead to more self-worth. Furthermore, studies show that self- worth mediates the association of hope with life satisfaction.
Objectives and research questions
The study aims to examine the effectiveness of the MY LIFE treatment, answering the following questions:
- Do adolescents with behavioral problems (age 14-20) receiving MY LIFE in addition to care as usual, have more hope after the treatment, compared to the adolescents in the waitinglist control group receiving only care as usual?
- Do adolescents with behavioral problems (age 14-20) receiving MY LIFE in addition to care as usual have a higher level of self-worth after the treatment, compared to the waitinglist control group receiving only care as usual?
- Do adolescents with behavioral problems (age 14-20) receiving MY LIFE in addition to care as usual seek more support after the treatment compared to the waitinglist control group receiving only care as usual?
- Do adolescents with behavioral problems (age 14-20) have more hope, a higher level of self-worth and seek more support after receiving MY LIFE, in comparison to pre-treatment? Secondary, this study focuses on the question:
- Is there a change in behavioral and emotional symptoms (emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, prosocial behavior, disruptive behavior, anger) in adolescents with behavioral problems (age 14-20) receiving MY LIFE in addition to care as usual, as compared to adolescents in the waitinglist control group receiving only care as usual? The second part of this study uses a structured interview to assess the subjective evaluation of the treatment by the adolescents.
Method Trial management The trial is funded by KFZ-J (Kwaliteit Forensische Zorg Jeugd) and led by a team of researchers and clinicians from the AmsterdamUMC and Levvel (youth mental health care).
Study design The study is a group randomized controlled trial, comparing Care As Usual (CAU) plus the MY LIFE treatment with a waitinglist control group receiving only CAU. The study procedure is depicted in figure 1. All adolescents and a chosen caretaker (CC) by the adolescent, will fill in questionnaires during a baseline assessment (T0). Six weeks later all adolescents and the CC will again fill in questionnaires during a post-measurement (T1). The waitinglist control group will receive the MY LIFE treatment after T1 and an additional post-measurement will be done after they have received the treatment (T2). All adolescents will be asked to fill in the questionnaires again 1 year after T0 (T3).
The Medical Ethics Review Committee of VU University Medical Center (METC) has reviewed the study protocol and concluded that the Medical Research Involving Human Subjects Act (WMO) does not apply to this study. The Medical Ethics Review Committee of VU University Medical Center is registered with the US Office for Human Research Protections (OHRP) as IRB00002991. The FWA number assigned to VU University Medical Center is FWA00017598.
Data management Since this is the first study on the MY LIFE treatment, and this treatment is different than interventions used in this population, it is difficult to estimate the expected effect and also the required sample size. Furthermore, previous studies in similar populations have demonstrated a large variety in effectsized of CBT-based interventions, ranging from small (d=0.33) to large (d=0.98) effects. To calculate the sample size for this study we used G* Power, with an estimation effect of (d=0.5), a power of β=0.8 and an ICC=0.6 to correct for dependency between the repeated measures. This resulted in an N of 50 adolescents per arm (in total N= 100) for this RCT.
A group randomized controlled trial will be performed to evaluate the effect of the intervention. All groups will receive care as usual within their youth care facility. The treatment group will also receive the MY LIFE treatment. Castor, a data management software program, will be used to store the data. To analyse the data a multilevel model with a three level structure (repeated measures are clustered within participants, and participants are clustered within groups) will be used via SPSS (Statistical Package for the Social Sciences). Analyses will be performed twice: once based on intention-to-treat (we consider this our primary analysis), and once including only those adolescents who completed the intervention. Missing data is taken into account by the multilevel analyses. Outliers deviating 3SD from the mean will be excluded.
The qualitative data will be analysed using ATLAS.ti.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Other: MY LIFE treatmentCare as Usual and the MY LIFE treatment |
| Waitinglist Control group | Active comparator | Other: Care as UsualCare as Usual |
Who may qualify
- Ages
- 14 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Adolescent is referred for behavioral problems
Key exclusion criteria (1 listed)
- School level is below BL (a school level in the Dutch school system)
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 |
|---|---|---|
| MY LIFE treatmentThe MY LIFE is a group treatment consisting of 5 workshops, for adolescents with a low motivation for mental health treatment. It aims to increase self- worth, hope for the future and seeking social support through exercises by using music and lyrics and other creative exercises to engage adolescents. The MY LIFE treatment also uses methods that stem from psychodynamic, cognitive behavioral, and solution focused theories. The therapeutic attitude is based on client-centered therapy of Rogers, which includes a genuine, positive regard and empathic understanding, focusing on the inner strength and growth potential of a person. Adolescents are never forced to participate during the workshops, merely encouraged. The core of the treatment is: the adolescent decides | Other | Treatment group |
| Care as UsualThe care as usual the adolescents receives | Other | Waitinglist Control group |
Primary outcome
JIJ questionnaire
Time frame: For the Treatment arm: at the first intake, 7 weeks after the intake, one year after the intake. For the waiting list control group: at the intake, 7 weeks after intake, 7 weeks later after treatment, one year after intake
Hope/ Self-worth/ Seeking support Self report
CHS (Children Hope Scale)
Time frame: For the Treatment arm: at the first intake, 7 weeks after the intake, one year after the intake. For the waiting list control group: at the intake, 7 weeks after intake, 7 weeks later after treatment, one year after intake
Hope Self report
BSCI-Y (Beck Self- Concept Inventory for Youth)
Time frame: For the Treatment arm: at the first intake, 7 weeks after the intake, one year after the intake. For the waiting list control group: at the intake, 7 weeks after intake, 7 weeks later after treatment, one year after intake
Self-worth Self report
UCL (S) Utrechtse Coping List Social support
Time frame: For the Treatment arm: at the first intake, 7 weeks after the intake, one year after the intake. For the waiting list control group: at the intake, 7 weeks after intake, 7 weeks later after treatment, one year after intake
Seeking support Self Report
JIJ questionnaire BA
Time frame: For the Treatment arm: at the first intake, 7 weeks after the intake. For the waiting list control group: at the intake, 7 weeks after intake, 7 weeks later after treatment.
Hope/ Self -worth/ Seeking support. Form is filled in by a caregiver chosen by the adolescent.
KLAD (Klachtenlijst Adolescenten) subscale self-worth
Time frame: For the Treatment arm: at the first intake, 7 weeks after the intake. For the waiting list control group: at the intake, 7 weeks after intake, 7 weeks later after treatment.
Self- Worth Form is filled in by caregiver chosen by the adolescent.
KLAD (Klachtenlijst Adolescenten) subscale social support
Time frame: For the Treatment arm: at the first intake, 7 weeks after the intake. For the waiting list control group: at the intake, 7 weeks after intake, 7 weeks later after treatment.
Seeking support Form is filled in by caregiver chosen by the adolescent
6 secondary outcomes
SDQ (Strengths and Difficulties Questionnaire)
Time frame: For the Treatment arm: at the first intake, 7 weeks after the intake. For the waiting list control group: at the intake, 7 weeks after intake, 7 weeks later after treatment.
BDBI-Y (Beck Disruptive Behavior Inventory for Youth)
Time frame: For the Treatment arm: at the first intake, 7 weeks after the intake, one year after the intake. For the waiting list control group: at the intake, 7 weeks after intake, 7 weeks later after treatment, one year after intake
BANI-Y (Beck Anger Inventory for Youth)
Time frame: For the Treatment arm: at the first intake, 7 weeks after the intake, one year after the intake. For the waiting list control group: at the intake, 7 weeks after intake, 7 weeks later after treatment, one year after intake
Workshop evaluation designed for the purpose of this study
Time frame: per workshop so every week during the treatment, 5 times
Strengths and Difficulties Questionnaire (SDQ) for parents or teachers
Time frame: For the Treatment arm: at the first intake, 7 weeks after the intake. For the waiting list control group: at the intake, 7 weeks after intake, 7 weeks later after treatment.
KLAD (Klachtenlijst Adolescenten) subscale emotional difficulties
Time frame: For the Treatment arm: at the first intake, 7 weeks after the intake. For the waiting list control group: at the intake, 7 weeks after intake, 7 weeks later after treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
- BackgroundAyotte, M. H., Lanctôt, N., & Tourigny, M. (2016). How the working alliance with adolescent girls in residential care predicts the trajectories of their behavior problems. Residential Treatment for Children & Youth, 33(2), 135-154. https://doi.org/10.1080/0886571x.2016.1175994
- Background: PubMed 25325990Barendregt CS, Van der Laan AM, Bongers IL, Van Nieuwenhuizen C. Adolescents in secure residential care: the role of active and passive coping on general well-being and self-esteem. Eur Child Adolesc Psychiatry. 2015 Jul;24(7):845-54. doi: 10.1007/s00787-014-0629-5. Epub 2014 Oct 18.
- Background: PubMed 26063543Barendregt CS, van der Laan AM, Bongers IL, van Nieuwenhuizen C. Longitudinal Relation Between General Well-Being and Self-Esteem. Int J Offender Ther Comp Criminol. 2016 Dec;60(16):1836-1855. doi: 10.1177/0306624X15588773. Epub 2016 Jul 28.
- Background: PubMed 28857691Baxter MA, Hemming EJ, McIntosh HC, Hellman CM. Exploring the Relationship Between Adverse Childhood Experiences and Hope. J Child Sex Abus. 2017 Nov-Dec;26(8):948-956. doi: 10.1080/10538712.2017.1365319. Epub 2017 Aug 31.
- BackgroundBoeije, H. (2016). Analyseren in kwalitatief onderzoek: Denken en doen. Boom Lemma.
- BackgroundDam, C. V., Nijhof, K. S., Scholte, R. H. J., & Veerman, J. W. (2010). Evaluatie nieuw zorgaanbod: Gesloten jeugdzorg voor jongeren met ernstige gedragsproblemen: Eindrapport
- Background: PubMed 15828981Donnellan MB, Trzesniewski KH, Robins RW, Moffitt TE, Caspi A. Low self-esteem is related to aggression, antisocial behavior, and delinquency. Psychol Sci. 2005 Apr;16(4):328-35. doi: 10.1111/j.0956-7976.2005.01535.x.
- BackgroundDu, H., Bernardo, A. B., & Yeung, S. S. (2015). Locus-of-hope and life satisfaction: The mediating roles of personal self-esteem and relational self-esteem. Personality and Individual Differences, 83, 228-233. https://doi.org/10.1016/j.paid.2015.04.026
- Background: PubMed 19708401Frydenberg E, Lewis R. Relations among well-being, avoidant coping, and active coping in a large sample of Australian adolescents. Psychol Rep. 2009 Jun;104(3):745-58. doi: 10.2466/PR0.104.3.745-758.
- Background: PubMed 31449683Granski M, Javdani S, Anderson VR, Caires R. A Meta-Analysis of Program Characteristics for Youth with Disruptive Behavior Problems: The Moderating Role of Program Format and Youth Gender. Am J Community Psychol. 2020 Mar;65(1-2):201-222. doi: 10.1002/ajcp.12377. Epub 2019 Aug 26.
- Background: PubMed 31556680Harris MA, Orth U. The link between self-esteem and social relationships: A meta-analysis of longitudinal studies. J Pers Soc Psychol. 2020 Dec;119(6):1459-1477. doi: 10.1037/pspp0000265. Epub 2019 Sep 26.
- Background: PubMed 8370852Horvath AO, Luborsky L. The role of the therapeutic alliance in psychotherapy. J Consult Clin Psychol. 1993 Aug;61(4):561-73. doi: 10.1037//0022-006x.61.4.561.
- Individual participant dataSharing planned: No. No sharing of data after the study. Merely for use in this particular study.
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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.
T.J. Dekkers, PhD study chair
AmsterdamUMC
J.W.R. Twisk, Prof.Dr study chair
AmsterdamUMC
A. Popma, Prof.Dr study director
AmsterdamUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MY LIFE treatment and Care as Usual in people with Behavior Problem, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yvonne Bors, MSc (031681150022, y.bors@levvel.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
JIJ questionnaire (time frame: For the Treatment arm: at the first intake, 7 weeks after the intake, one year after the intake. For the waiting list control group: at the intake, 7 weeks after intake, 7 weeks later after treatment, one year after intake). The study lists 7 primary outcomes in all. 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 NCT05581914, which also lists 22 linked publications.
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 17 Oct 2022.