NCT05581914

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

October 6, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 17, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

October 17, 2022

Status Verified

October 1, 2022

Enrollment Period

1.2 years

First QC Date

October 5, 2022

Last Update Submit

October 12, 2022

Conditions

Keywords

Behavioral problemsTransdiagnostic treatmentAdolescentsSelf-worthHopeSeeking supportPeer expert

Outcome Measures

Primary Outcomes (7)

  • JIJ questionnaire

    Hope/ Self-worth/ Seeking support Self report

    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

    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

    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

    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.

    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.

    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

    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)

    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)

    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)

    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

    per workshop so every week during the treatment, 5 times

  • Strengths and Difficulties Questionnaire (SDQ) for parents or teachers

    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.

  • +1 more secondary outcomes

Other Outcomes (1)

  • Evaluation of the MY LIFE treatment

    6 weeks after start treatment

Study Arms (2)

Treatment group

EXPERIMENTAL

Care as Usual and the MY LIFE treatment

Other: MY LIFE treatment

Waitinglist Control group

ACTIVE COMPARATOR

Care as Usual

Other: Care as Usual

Interventions

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

Treatment group

The care as usual the adolescents receives

Waitinglist Control group

Eligibility Criteria

Age14 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adolescent is referred for behavioral problems

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Levvel

Amsterdam, North Holland, 1076EC, Netherlands

RECRUITING

Related Publications (22)

  • 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

    BACKGROUND
  • 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.

    PMID: 25325990BACKGROUND
  • Barendregt 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.

    PMID: 26063543BACKGROUND
  • Baxter 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.

    PMID: 28857691BACKGROUND
  • Boeije, H. (2016). Analyseren in kwalitatief onderzoek: Denken en doen. Boom Lemma.

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 15828981BACKGROUND
  • Du, 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
  • 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.

    PMID: 19708401BACKGROUND
  • Granski 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.

    PMID: 31449683BACKGROUND
  • Harris 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.

    PMID: 31556680BACKGROUND
  • Horvath 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.

    PMID: 8370852BACKGROUND
  • McLeod 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.

    PMID: 21482319BACKGROUND
  • Muarifah 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.

    PMID: 35621444BACKGROUND
  • Peeters, J. (1994). Klachtenlijst voor adolescenten: KLAD (Complaintlist for Adolescents). Gedragstherapie, 27(2), 109-125.

    BACKGROUND
  • Riise EN, Wergeland GJH, Njardvik U, Ost LG. Cognitive behavior therapy for externalizing disorders in children and adolescents in routine clinical care: A systematic review and meta-analysis. Clin Psychol Rev. 2021 Feb;83:101954. doi: 10.1016/j.cpr.2020.101954. Epub 2020 Dec 7.

    PMID: 33418192BACKGROUND
  • ROGERS CR. Significant aspects of client-centered therapy. Am Psychol. 1946 Oct;1(10):415-22. doi: 10.1037/h0060866. No abstract available.

    PMID: 20280375BACKGROUND
  • Sanetti, L. M. H., Cook, B. G., & Cook, L. (2021). Treatment fidelity: What it is and why it matters. Learning Disabilities Research& Practice, 36(1), 5-11.

    BACKGROUND
  • Schreurs, P. J. P., Van de Willige, G., Tellegen, B., Brosschot, J. F., & Graus, G. M. H. (1993). De Utrechtse coping lijst: UCL: omgaan met problemen en gebeurtenissen. Harcourt Test Publ.

    BACKGROUND
  • Sheffler JL, Piazza JR, Quinn JM, Sachs-Ericsson NJ, Stanley IH. Adverse childhood experiences and coping strategies: identifying pathways to resiliency in adulthood. Anxiety Stress Coping. 2019 Sep;32(5):594-609. doi: 10.1080/10615806.2019.1638699. Epub 2019 Jul 9.

    PMID: 31288568BACKGROUND
  • Twisk J, de Boer M, de Vente W, Heymans M. Multiple imputation of missing values was not necessary before performing a longitudinal mixed-model analysis. J Clin Epidemiol. 2013 Sep;66(9):1022-8. doi: 10.1016/j.jclinepi.2013.03.017. Epub 2013 Jun 21.

    PMID: 23790725BACKGROUND
  • Twisk, J. W. R. (2021). Analysis of data from randomized controlled trials: A practical guide (1st ed. 2021). Springer.

    BACKGROUND

MeSH Terms

Conditions

Mental DisordersProblem Behavior

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorChild Behavior

Study Officials

  • T.J. Dekkers, PhD

    AmsterdamUMC

    STUDY CHAIR
  • J.W.R. Twisk, Prof.Dr

    AmsterdamUMC

    STUDY CHAIR
  • A. Popma, Prof.Dr

    AmsterdamUMC

    STUDY DIRECTOR

Central Study Contacts

Yvonne Bors, MSc

CONTACT

Helena Oldenhof, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor Helena Oldenhof (PhD) Sponsor-Investigator

Study Record Dates

First Submitted

October 5, 2022

First Posted

October 17, 2022

Study Start

October 6, 2022

Primary Completion

December 1, 2023

Study Completion

February 1, 2024

Last Updated

October 17, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

No sharing of data after the study. Merely for use in this particular study.

Locations