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Randomized Feasibility Trial of Mind My Mind

NCT03448809 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2018-02-28

No results posted yet for this study

Summary

In this feasibility RCT of the modular and flexible cognitive and behavioural therapy (Mind My Mind, MMM) compared with treatment as usual, the overall research aim was to explore the trial design and the acceptability of the assessments, interventions and outcome measures among children, parents, teachers and therapists, and secondly to provide data to estimate the parameters required to design a definitive RCT.

Conditions

  • Anxiety
  • Anxiety Disorders
  • Depressive Symptoms
  • Depressive Disorder
  • Problem Behavior
  • Oppositional Defiant Disorder
  • Conduct Disorder
  • Behavior Disorders

Interventions

BEHAVIORAL

Mind My Mind

An individual, modular and flexible cognitive and behavioural therapy

BEHAVIORAL

TAU (Treatment as Usual)

The children were offered anonymous counselling, supportive talk therapy, pedagogical advice, network meetings, and/or individual support in the school setting. A few were offered group-based CBT-programs for selected problems, but the access to manualized treatment was generally very restricted.

Sponsors & Collaborators

  • TrygFonden, Denmark

    collaborator INDUSTRY

  • The Danish Mental Health Foundation

    collaborator OTHER

  • Mental Health Services in the Capital Region, Denmark

    lead OTHER

Principal Investigators

  • Pia Jeppesen, Ph.D. · Child and Adolescent Mental Health Centre, Mental Health Services of the Capital Region of Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-08
Primary Completion
2017-04-02
Completion
2017-04-02

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03448809 on ClinicalTrials.gov