Randomized Feasibility Trial of Mind My Mind

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital150 enrolled

Overview

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.

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 (MMM) study in Denmark is a multidisciplinary collaborative effort to adapt current evidence-based treatment strategies for implementation with school children in diverse municipalities in Denmark. The overarching goals of the Mind My Mind study are to develop, implement, evaluate and disseminate a program for the prevention and treatment of children's emotional and behavioral disturbances at the lowest effective level. Methods: A parallel, two-arm trial compared the modular and flexible cognitive and behavioral therapy (Mind My Mind, MMM) with treatment as usual (TAU) for children aged 6-16 years with subclinical or clinical levels of emotional and behavioral difficulties. The trial was conducted in diverse municipalities in Denmark in the period from December 2015 to March 2017. Participants were help-seeking school-children with indicated needs for psychological help. The help-seeking children entered a two-stage screening for eligibility by web-based standardized psychometric instruments: 1) the strengths and difficulties questionnaire (SDQ), 2) the Child Behaviour Checklist (CBCL) and the Youth Self-Report (YSR). This screening procedure was set up as a new routine in the Pedagogical Psychological Services (PPR) in the Municipalities. The screening enabled PPR to identify children with anxiety, depressive symptoms and/or behavioral problems causing distress/impact in their daily life (eligible for the study) versus those with too mild problems (excluded based on SDQ-parent-scores below a pre-specified cut-off according to an algorithm) or too severe problems (excluded and referred to the Child and Adolescent Psychiatry or other specialized services). If the child was eligible, both parents were asked to give informed consent to inclusion of the child in the research study. The included children were randomized (3:1) to MMM versus TAU. All outcomes were measured by use of self-, parent-, and teacher-reported questionnaires covering specific and general psychopathology, daily and social functioning, quality of life of the child, and parental distress at baseline, week 14 and week 22. At entry, the child and the parent formulated each three problems that they wanted to change. The Top-3-problems were written into the web-based questionnaire using their own words. Then, each problem was scored on a 10-point likert scale along with scoring of the Brief Problem Monitor (BPM) by the child and the parent separately. These scores were collected weekly during the treatment period, at end of treatment (week 14) and at follow-up (week 22). The satisfaction with the MMM sessions was also scored weekly (MMM arm only). The primary objectives and outcomes measures: 1. To assess the flow of participants through the visitation 2. To explore whether the visitation procedures, and the inclusion and exclusion criteria were applicable and appropriate for the recruitment. The included and the excluded children were described and compared with regard to the family and social characteristics, and the type and severity of psychopathology as measured with the SDQ, CBCL and YSR. 3. To assess the retention of children in the MMM arm. 4. To assess the proportion of children in the MMM arm who were referred to more specialized services during the study period. 5. To assess the satisfaction with MMM sessions among children and parents in the MMM arm. 6. To describe the dosing and sequencing of the MMM modules as reported by the therapists after each session and compare the actual use of the MMM manual with the intended use according to the manual. The secondary objectives and outcomes measures: 1. To measure the key outcome domains with regard to completion rates, missing data, and the estimated differences between MMM and TAU. 2. To perform an initial validation of the Top-3-problem-scores by studying the correlations between the scores within and across informants, across time, and the correlations between the Top-3-problem-scores and the BPM-scores. Statistical analyses: The feasibility measures were summarized using standard descriptive statistics. The group differences in outcome were analyzed in intention-to-treat (ITT) analyses using mixed models repeated measures or linear regression analyses with multiple imputations. Perspectives: The new modular and flexible manual, the centralized education and supervision of the psychologists, and the web-based data collection with feedback in real time was implemented in an explanatory feasibility trial to prepare for a future definitive RCT.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Interventions

Mind My MindBEHAVIORAL

An individual, modular and flexible cognitive and behavioural therapy

TAU (Treatment as Usual)BEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged 6-16 years and in 0-9th grade (excluding the second semester of the 9th grade). 2. Bother genders. 3. Child and/or parents report that the child has problems within the domains of anxiety, depressive symptoms and behavioral problems. 4. 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. 5. The child and at least one of the two parents understand and speak Danish sufficiently to participate in the treatment. 6. Written informed consent from the holders of the parental rights and responsibilities (usually both parents). Exclusion Criteria: 1. 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). 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. The child has a clinically significant abuse of alcohol or psychoactive drugs 4. Parents did not answer the SDQ and CBCL during visitation

Outcomes

Primary Outcomes

The flow of participants through the visitation.

The number of children/parents who accepted the invitation to sign up for visitation to the study The number successfully screened and assessed for eligibility. The number estimated to be eligible. The proportion of eligible children for whom the parents gave informed consent to let the child participate in the research study. The number excluded in total, and calculated for each inclusion and exclusion criteria.

Time frame: At baseline (week 0).

The family and social background characteristics.

One of the parents served as an informant. The questionnaire was developed for the Mind My Mind and asked about the family composition including if parents are separated, divorced or living together, how much time the child spend with each parent, early developmental problems, physical and mental health problems and disorders, school problems related to learning, social functioning and absence from school, child's history of having received any pedagogical educational support, medicine, psychological or psychiatric treatments; and parents' education and self-reported mental health problems.

Time frame: At baseline (week 0).

The Strengths and Difficulties Questionnaire (SDQ).

SDQ contains 25 items, each scored on a 3-point Likert scale (0, 1, 2), and divided into five sub-scales measuring emotional problems, behavioral problems, hyperactivity, peer problems and pro-social behavior. The extended version included questions about child distress and interference of problems with home-life, friendships, classroom learning and leisure activities, summed up the distress and the interference of problems in the impact score (range 0-10). For screening purposes, high-risk and low-risk groups were defined by cut-offs for the top 10th percentile of the Danish population. Informants: The SDQ was answered by the child (only age 11 -16 years) and the parent. For those children included in the research trial, the school teacher was requested to answer the SDQ.

Time frame: At baseline (week 0).

The retention of children in the MMM arm.

The proportion continuing training until the agreed and planned ending (minimum 9 sessions) among the total number of children being allocated to MMM training.

Time frame: At end of treatment (week 14).

The proportion of children in the MMM arm who were referred to more specialized services during the study period.

The number referred to child and adolescent psychiatry or other specialized services according to the mandatory records made by the psychologist at end of the each MMM training.

Time frame: At end of treatment (week 14)

The satisfaction with MMM sessions among children and parents in the MMM arm.

The questionnaire contains six questions: 1) I liked the last meeting, 2) I learned something new at the last meeting, 3) All in all, I understood the tasks, 4) I can use what I learned at the last meeting, 5) I felt that the trainer understood me, 6) The trainer presented the tasks in a good way for me. The questionnaire was scored after each MMM session by the child or by the parent, depending on who was the primary recipient in the given session (as recorded by the therapist). Each question was scored on 5-point likert-scale, score 1 = "very unsatisfied" and 5 = "very satisfied".

Time frame: Within one week after each MMM session.

The dosing and sequencing of the MMM modules.

The trainer made a record of each training session including information on the current principal problem domain (anxiety, depressive symptoms, behavioural problems), the selected path, modules and worksheets used in the session, the participant (child, parents) the primary recipient, and, if it was the last session, how the training ended (ending as planned, drop out, referral to support/treatment outside the manual).

Time frame: Within one day after each MMM session.

The authorized Danish version of the Achenbach System of Empirically Based Assessment (ASEBA), Child Behaviour Checklist (CBCL).

The Child Behaviour Checklist for 6-16-year-olds was answered by the parent. The part with 112 problem items was used. These are statements answered on a Likert scale: zero equals "not true", one equals "partly true or sometimes", two equals "very true or frequently". CBCL derives total problem score, and subscale scores for externalizing and internalizing problems.

Time frame: At baseline (week 0)

The authorized Danish version of the Achenbach System of Empirically Based Assessment (ASEBA), the Youth Self-Report (YSR).

The YSR was answered by the child (age 11-16- years). The part with 112 problem items was used. These are statements answered on a Likert scale: zero equals "not true", one equals "partly true or sometimes", two equals "very true or frequently". YSR derives total problem score, and subscale scores for externalizing and internalizing problems.

Time frame: At baseline (week 0)

Secondary Outcomes

Spence Children's Anxiety Scale (SCAS)

The SCAS comprises parent- and youth-reported questionnaires with 38 and 44 items, respectively. Each is rated on a four-point scale (0-1-2-3). The self-reported version is longer because it includes six positive filler items. The SCAS consists of six subscales reflecting symptoms specifically related to social phobia (SoP; six items), panic disorder and agoraphobia (Panic; nine items), generalized anxiety disorder (GAD; six items), obsessive-compulsive disorder (OCD; six items), separation anxiety disorder (SAD; six items) and fear of physical injury (Fear; five items). Each subscale is scored separately and added together for a total score reflecting overall anxiety symptoms. A validation of the Danish version of the SCAS in children and adolescents aged 7-17 years found good psychometric properties.