Status:
COMPLETED
Randomized Feasibility Trial of Mind My Mind
Lead Sponsor:
Mental Health Services in the Capital Region, Denmark
Collaborating Sponsors:
TrygFonden, Denmark
The Danish Mental Health Foundation
Conditions:
Anxiety
Anxiety Disorders
Eligibility:
All Genders
6-16 years
Phase:
NA
Brief 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...
Detailed Description
Background and aims: Emotional and behavioral disorders are common in youths, and large-scale implementation of evidence-based treatments lack behind the needs of the population. The Mind My Mind (MM...
Eligibility Criteria
Inclusion
- Aged 6-16 years and in 0-9th grade (excluding the second semester of the 9th grade).
- Bother genders.
- Child and/or parents report that the child has problems within the domains of anxiety, depressive symptoms and behavioral problems.
- SDQ scores reported by the parent are above the lower cutoff: a total difficulties score of ≥14 and/or emotional problems ≥5; combined with a functional impairment score of ≥1.
- The child and at least one of the two parents understand and speak Danish sufficiently to participate in the treatment.
- Written informed consent from the holders of the parental rights and responsibilities (usually both parents).
Exclusion
- Indications based on the available information that the child may have a severe mental disorder like autism spectrum disorder, ADHD, schizophrenia-like psychosis, an eating disorder, or other mental disorder requiring referral to a more intensive assessment or treatment in child and adolescent mental health services (after systematic assessment and according to the usual recommendations and guidelines).
- Indications of intellectual functional impairment, severe learning difficulties or other special needs that would interfere negatively with the MMM training. The judgment is made as a best estimate by the PPR psychologist on the basis of the available information. A formal intelligence test is not required.
- The child has a clinically significant abuse of alcohol or psychoactive drugs
- Parents did not answer the SDQ and CBCL during visitation
Key Trial Info
Start Date :
December 8 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2017
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03448809
Start Date
December 8 2015
End Date
April 2 2017
Last Update
February 28 2018
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