Clinical trial NCT03535805: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Keywords: Cognitive and Behavioral Therapies
Children and Adolescents
Community Health Care
Early Intervention
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
Collaborators: name: TrygFonden, Denmark
name: The Danish Mental Health Foundation
name: Defactum, Central Denmark Region
First posted: 2018-05-24
Enrollment: 396
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The child's impact of mental health problems reported by the parent on the Strengths and Difficulties Questionnaire (SDQ)
timeFrame: Week 0, 2, 4, 6, 8, 10, 12, 14, 18 and 26
Secondary outcomes:
measure: Child' anxiety reported by the parent on 'Spence Children's Anxiety Scale (SCAS)
timeFrame: Week 0, 18 and 26
measure: Child's depressive symptoms reported by the parent on the Mood and Feelings Questionnaire (MFQ)
timeFrame: Week 0, 18 and 26
measure: Weiss Functional impairment rating Scale (WFIRS)
timeFrame: Week 0, 18 and 26
measure: The self-reported physical and psychological well-being (two subscales from the KIDSCREEN).
timeFrame: Week 0, 18 and 26
measure: The child's behavioural problems, reported by the parent on the Eyberg Child Behaviour Inventory (ECBI)
timeFrame: Week 0, 18 and 26
measure: Total emotional and behavioural difficulties, reported by parents (SDQ)
timeFrame: Week 0, 18 and 26.
measure: School attendance
timeFrame: Week 18 and 26
measure: Top-problem scores, parent-reported
timeFrame: Week 0, 2, 4, 6, 8, 10, 12, 14, 18 and 26
measure: The self-reported impact of mental health problems (SDQ, only children of age ≥ 11 years)
timeFrame: Week 0, 2, 4, 6, 8, 10, 12, 14, 18 and 26
measure: The teacher-reported impact of mental health problems (SDQ)
timeFrame: Week 0, 18 and 26
measure: Self-reported anxiety reported (SCAS, only children of age ≥ 8 years)
timeFrame: Week 0, 18 and 26
measure: Self-reported depressive symptoms (MFQ, only children of age ≥ 8 years)
timeFrame: Week 0, 18 and 26
measure: Self-reported Top-problem scores
timeFrame: Week 0, 2, 4, 6, 8, 10, 12, 14, 18 and 26
measure: The parent-reported Health-Related Quality of Life (HRQOL) of their child (KIDSCREEN)
timeFrame: Week 0, 18 and 26
measure: Self-reported emotional and behavioural difficulties (SDQ, only children of age ≥ 11 years)
timeFrame: Week 0, 18 and 26
measure: Teacher-reported emotional and behavioural difficulties (SDQ)
timeFrame: Week 0, 18 and 26
measure: Parental Stress Scale (PSS)
timeFrame: Week 0, 18 and 26
measure: The parent-reported Experience of Service Questionnaire (ESQ)
timeFrame: Week 18 and 26
measure: The self-reported Experience of Service Questionnaire (ESQ)
timeFrame: Week 18 and 26
measure: The parent- and child-reported Child Health Utility 9D (CHU9D)
timeFrame: Week 0, 18 and 26
measure: Parents' absence from work
timeFrame: Week 0, 18 and 26
measure: Treatment and support received by the child and the family
timeFrame: Week 0, 18 and 26
measure: The primary measures of potential harms
timeFrame: Week 18 and 26
measure: The secondary measures of potential harm
timeFrame: Week 18 and 26
measure: Costs
timeFrame: Week 26
measure: Incremental cost-effectiveness ratio (ICER)
timeFrame: Week 26
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Mental Health Services in the Capital Region, Denmark
Study officials:
affiliation: Mental Health Services in the Capital Region, Denmark
name: Pia Jeppesen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jeppesen P, Wolf RT, Nielsen SM, Christensen R, Plessen KJ, Bilenberg N, Thomsen PH, Thastum M, Neumer SP, Puggaard LB, Agner Pedersen MM, Pagsberg AK, Silverman WK, Correll CU. Effectiveness of Transdiagnostic Cognitive-Behavioral Psychotherapy Compared With Management as Usual for Youth With Common Mental Health Problems: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Mar 1;78(3):250-260. doi: 10.1001/jamapsychiatry.2020.4045.