Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances

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Brief Title

Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances

Official Title

Randomized Trial of a Transdiagnostic, Cognitive and Behavioral Intervention Versus Treatment as Usual in School-aged Children With Emotional and Behavioral Disturbances

Brief Summary

      Background

      Impairing emotional and behavioural problems are common in children and adolescents and mark
      a three-fold increased risk of mental disorder in young adulthood. Evidence-based
      psychological interventions are recommended for indicated prevention and first-line
      treatment, but access to treatment is often limited.

      A new, modular cognitive and behavioural therapy program Mind My Mind (MMM) comprising
      evidence-based interventions for children with emotional and behavioral problems was designed
      to be delivered by educational psychologists in the Danish municipalities.

      A feasibility RCT (NCT03448809), demonstrated that the study design was acceptable among
      children, parents, and therapists, and it provided data to estimate the sample size needed
      for the definitive RCT. The investigators test the hypothesis that the parent-reported impact
      of mental health problems will be significantly lower for children in the MMM group as
      compared with children in the TAU group after the 18-week intervention period (primary
      hypothesis), and after follow-up at week 26 (first secondary hypothesis).

      Aim

      To investigate the effects and cost-effectiveness of MMM compared with TAU for children and
      adolescents with impairing anxiety, depressive symptoms and/or behavioral problems. Both
      beneficial and harmful effects are evaluated.

      Methods

      The study compares the new modular MMM with TAU for children aged 6-16 years with anxiety,
      depressive symptoms or behavioral problems impacting on their daily and social life. The
      trial is conducted in four Danish municipalities in the period from September 2017 to April
      2019. Participants are children with indicated needs.

      The parents sign up the child for assessment in the Pedagogical Psychological Services in the
      Municipalities. The assessment includes web-based standardized questionnaires for child and
      parent: 1) the strengths and difficulties questionnaire (SDQ), 2) Spence Children's Anxiety
      Scale, 3) Mood and Feelings Questionnaire, and 4) family, social and school functioning. The
      questionnaires are supplemented with a clinical psychopathological interview by a trained
      psychologist. The investigators exclude children with 1) low levels of problems and no
      indicated needs, or 2) high levels of problems and need of referral to the Child and
      Adolescent Psychiatry.

      412 children will be included and randomized (1:1) to MMM versus TAU. MMM is supported by a
      central organization, who is responsible for the education and weekly supervision of the
      therapists, and the web-based data collection and feedback of data in real time to therapists
      and researchers. All outcomes are self-, parent- and teacher-reported scores on standardized
      questionnaires administered at baseline, week 18 and week 26. At entry, the child and the
      parents own description of the Top-problem is recorded and scored on a 10-point likert scale.
      The Top-problem and impact of problem is scored by parent and child every second week during
      the intervention period, and the progress is monitored by the therapists in the MMM group.
      Information on costs is gathered through administrative registers and questionnaires at
      baseline, week 18, and week 26.

      Primary objectives and outcome measures

      This primary outcome is measured with the parent-reported SDQ impact-scale. The minimum
      relevant difference in impact of mental health problems was set at 1.0 corresponding to a
      change from severe to moderate, or from moderate to little-or-no impact in one of five
      domains of child's life: distress, home-life, friendships, classroom learning and leisure
      activities.

      Secondary objectives and outcomes measures

      The key secondary hypotheses are that the children in the MMM group will show significantly
      lower levels of parent-reported anxiety, depressive symptoms, functional impairment,
      Top-problems and behavioural problems, and better school attendance and quality-of-life as
      compared with the children in the TAU group at week 18.

      All other outcomes are explored at week 18 and 26, including the primary and secondary
      measures of potential harm: 1) youths with severe and increased levels of self-reported
      suicidality, hopelessness and/or negative self-evaluation, and 2) youths with poor quality of
      life in relation to family, free time and friends.

      Statistical analyses

      All analyses will be intention-to-treat with two-sided significance tests. The investigators
      will use mixed models with repeated measures for continuous outcomes and generalized linear
      mixed model for binary and non-normally distributed outcomes. For the key secondary outcomes,
      the investigators will use the strategy of hierarchical testing allowing us to preserve the
      level of significance, α=0.05, as long as the null hypotheses are rejected. The incremental
      cost-effectiveness ratio will be calculated to analyze cost-effectiveness.

      Perspectives

      The results will guide policy makers in deciding whether to implement modular CBT-programs
      like the MMM.
    



Study Type

Interventional


Primary Outcome

The child's impact of mental health problems reported by the parent on the Strengths and Difficulties Questionnaire (SDQ)

Secondary Outcome

 Child' anxiety reported by the parent on 'Spence Children's Anxiety Scale (SCAS)

Condition

Anxiety

Intervention

Mind My Mind (MMM)

Study Arms / Comparison Groups

 Mind My Mind (MMM)
Description:  Mind My Mind (MMM)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

396

Start Date

September 7, 2017

Completion Date

August 26, 2019

Primary Completion Date

July 15, 2019

Eligibility Criteria

        Inclusion Criteria:

          1. Aged 6-16 years and in 0-9th grade (excluding the second semester of the 9th grade).

          2. SDQ scores reported by the parent are above the lower cutoff: a total difficulties
             score of ≥14 and/or emotional problems ≥5, and/or conduct score ≥3; combined with a
             functional impairment score of ≥1. Scores above this cutoff place the child's
             difficulties within the top 10 percent of mental health problems in the general
             age-matched population in Denmark.

          3. The child and parents determine one top problem that has to fall within the domains of
             anxiety, depressive symptoms or behavioral problems, according to the classification
             by the PPR (Pedagogical Psychological Services in the Municipalities) psychologist.

          4. The child and at least one of the two parents understand and speak Danish sufficiently
             to participate in the treatment.

          5. Written informed consent from the holders of the parental rights and responsibilities
             (usually both parents).

        Exclusion Criteria:

          1. Indications that the child may have a severe mental disorder like autism spectrum
             disorder, Attention Deficit Hyperactivity Disorder, schizophrenia-like psychosis, an
             eating disorder, severe obsessive-compulsive disorder, repeated self-harm, abuse or
             dependence of alcohol or psychoactive drugs 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).

          2. 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.

          3. A prior diagnosis of any developmental or mental disorder after assessment by the
             regional child and adolescent psychiatry, regardless of present status or treatment. A
             prior examination that did not result in a diagnosis of any specific mental health
             disorder will not exclude the child. The PPR psychologist must consult the PI who
             decides whether there is sufficient information to exclude the child because of a
             prior psychiatric history.

          4. Prior participation in the MMM pilot or current study.

          5. The child and/or parents are unable to participate in weekly sessions throughout the
             next 13-18 weeks.
      

Gender

All

Ages

6 Years - 16 Years

Accepts Healthy Volunteers

No

Contacts

Pia Jeppesen, PhD, , 

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations


NCT ID

NCT03535805

Organization ID

The Mind My Mind Trial


Responsible Party

Principal Investigator

Study Sponsor

Mental Health Services in the Capital Region, Denmark

Collaborators

 TrygFonden, Denmark

Study Sponsor

Pia Jeppesen, PhD, Principal Investigator, Mental Health Services in the Capital Region, Denmark


Verification Date

September 2019