Clinical trial NCT05581914: Effectiveness of the MY LIFE Treatment for Adolescents With Behavioral Problems
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Behavior Problem
Keywords: Behavioral problems
Transdiagnostic treatment
Adolescents
Self-worth
Hope
Seeking support
Peer expert
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2022-10-17
Enrollment: 100
Sex: ALL
Minimum age (years): 14
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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:

1. 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?
2. 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?
3. 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?
4. 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:
5. 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.

Eligibility criteria: Inclusion Criteria:

Adolescent is referred for behavioral problems

Exclusion Criteria:

School level is below BL (a school level in the Dutch school system)

Primary outcomes:
measure: JIJ questionnaire
timeFrame: 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
measure: CHS (Children Hope Scale)
timeFrame: 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
measure: BSCI-Y (Beck Self- Concept Inventory for Youth)
timeFrame: 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
measure: UCL (S) Utrechtse Coping List Social support
timeFrame: 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
measure: JIJ questionnaire BA
timeFrame: 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.
measure: KLAD (Klachtenlijst Adolescenten) subscale self-worth
timeFrame: 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.
measure: KLAD (Klachtenlijst Adolescenten) subscale social support
timeFrame: 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:
measure: SDQ (Strengths and Difficulties Questionnaire)
timeFrame: 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.
measure: BDBI-Y (Beck Disruptive Behavior Inventory for Youth)
timeFrame: 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
measure: BANI-Y (Beck Anger Inventory for Youth)
timeFrame: 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
measure: Workshop evaluation designed for the purpose of this study
timeFrame: per workshop so every week during the treatment, 5 times
measure: Strengths and Difficulties Questionnaire (SDQ) for parents or teachers
timeFrame: 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.
measure: KLAD (Klachtenlijst Adolescenten) subscale emotional difficulties
timeFrame: 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.
Other outcomes:
measure: Evaluation of the MY LIFE treatment
timeFrame: 6 weeks after start treatment
Locations:
city: Amsterdam
country: Netherlands
facility: Levvel
state: Noord-Holland
Study officials:
affiliation: AmsterdamUMC
name: T.J. Dekkers, PhD
role: STUDY_CHAIR
affiliation: AmsterdamUMC
name: J.W.R. Twisk, Prof.Dr
role: STUDY_CHAIR
affiliation: AmsterdamUMC
name: A. Popma, Prof.Dr
role: STUDY_DIRECTOR
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