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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

396 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-07

Study Completion Date

2019-08-26

Brief Summary

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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

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Detailed Description

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Conditions

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Anxiety Anxiety Disorders Depressive Symptoms Depressive Disorders Problem Behavior Oppositional Defiant Disorder Conduct Disorder Other Behavioral and Emotional Disorders With Onset Usually Occurring in Childhood and Adolescence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The RCT is a parallel, two-arm, superiority trial comparing MMM with TAU for children aged 6-16 years with emotional and behavioural difficulties.

This primary outcome is the parent-reported SDQ-impact of problems (range 0-10). The sample size calculation was based on the parameters from the feasibility RCT. Given an estimated standard variation (SD)=2.7, significance level=0.05, and power=0.90, the sample required to detect (or reject) a difference of at least 1.0 point is N=308. This sample size is also sufficient to detect clinically meaningful group differences in secondary outcome (e.g. 7.5% versus 16% reporting harm).

The expected rate of attrition is 0.25. Hence, the investigators need to include 308/0.75=412 children to be randomly allocated (1:1). The central randomization uses concealed allocation sequences with variable block size, and stratification by region, age (6-10 or 11-16 years) and Top-problem (anxiety, depression, behavioural problems).

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The statistical evaluation of the effects of MMM versus TAU will be carried out by researchers who will be masked for the treatment allocation.

The central research-organization DEFACTUM is responsible for holding separate key files documenting the random allocation to treatment group and linking the ID numbers to the personal civil registration numbers. The analysts will be masked for treatment allocation until they have tested the primary and secondary hypotheses and confirmed or rejected the study hypotheses.

It is not possible to mask the participants and the therapists in this study design.

Study Groups

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Mind My Mind (MMM)

Group Type EXPERIMENTAL

Mind My Mind (MMM)

Intervention Type BEHAVIORAL

Mind My Mind (MMM) is a new transdiagnostic and modular cognitive and behavioural therapy (CBT) program comprising evidence-based interventions for children and adolescents with anxiety, depression or disruptive behavior.

MMM manual consists of evidence-based CBT methods that are organized into modules. The intervention is tailored to the individual child by the dosing and the sequencing of the modules. Trauma-focused CBT is available. Parents are engaged in child's therapy and support the child in doing the homework. Parent management training is offered for behavioral disturbances. The educational psychologists deliver the therapy after one-week training in the manual, followed by weekly supervision. The treatment fidelity is monitored by video observation of therapy sessions (\>20%).

The MMM training program consists of 9-13 sessions plus one booster, all completed within 17 weeks.

Treatment as Usual (TAU)

Group Type ACTIVE_COMPARATOR

Treatment as Usual (TAU)

Intervention Type BEHAVIORAL

The parents in the TAU group are offered two sessions (week 2 and week 17) to support their attempts to seek help for the child in the municipality. This coordination is provided by psychologists (or other local professionals) who hold records of the currently available treatment options in the municipality. The TAU vary considerably from no intervention to counselling, talk therapy, pedagogical advice, network meetings, and/or individual support in the school setting. Some children are offered CBT interventions, but access to manualized treatment is generally very limited.

Interventions

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Mind My Mind (MMM)

Mind My Mind (MMM) is a new transdiagnostic and modular cognitive and behavioural therapy (CBT) program comprising evidence-based interventions for children and adolescents with anxiety, depression or disruptive behavior.

MMM manual consists of evidence-based CBT methods that are organized into modules. The intervention is tailored to the individual child by the dosing and the sequencing of the modules. Trauma-focused CBT is available. Parents are engaged in child's therapy and support the child in doing the homework. Parent management training is offered for behavioral disturbances. The educational psychologists deliver the therapy after one-week training in the manual, followed by weekly supervision. The treatment fidelity is monitored by video observation of therapy sessions (\>20%).

The MMM training program consists of 9-13 sessions plus one booster, all completed within 17 weeks.

Intervention Type BEHAVIORAL

Treatment as Usual (TAU)

The parents in the TAU group are offered two sessions (week 2 and week 17) to support their attempts to seek help for the child in the municipality. This coordination is provided by psychologists (or other local professionals) who hold records of the currently available treatment options in the municipality. The TAU vary considerably from no intervention to counselling, talk therapy, pedagogical advice, network meetings, and/or individual support in the school setting. Some children are offered CBT interventions, but access to manualized treatment is generally very limited.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Pia Jeppesen

Ph.D., Senior Researcher, Specialist in Child and Adolescent Psychiatry, and Associate Professor, Institute for Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.

Responsibility Role PRINCIPAL_INVESTIGATOR