Randomized Feasibility Trial of Mind My Mind

NCT03448809 | Completed

• 1 other identifier: MMMpilotrct
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Anxiety; Anxiety Disorders; Depressive Symptoms; Depressive Disorder; Problem Behavior; Oppositional Defiant Disorder; Conduct Disorder; Behavior Disorders

Keywords

Cognitive and Behavioral Therapies; Children and Adolescents; Community Health Care; Early Intervention; Feasibility Study

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  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.

  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.

  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.

  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".

  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).

  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.

  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.

  At baseline (week 0)

Secondary Outcomes (10)

• Spence Children's Anxiety Scale (SCAS)

  Baseline (week 0), end of treatment (week 14), and follow-up (week 22).

• The Mood and Feelings Questionnaire (MFQ)

  Baseline (week 0), end of treatment (week 14), and follow-up (week 22).

• The KIDSCREEN

  Baseline (week 0), end of treatment (week 14), and follow-up (week 22).

• Eyberg Child Behaviour Inventory (ECBI)

  Baseline (week 0), end of treatment (week 14), and follow-up (week 22).

• Weiss Functional impairment rating Scale (WFIRS)

  Baseline (week 0), end of treatment (week 14), and follow-up (week 22).

Study Arms (2)

MMM (Mind My Mind training)

EXPERIMENTAL

Mind My Mind training

Behavioral: Mind My Mind

TAU (Treatment as Usual)

ACTIVE COMPARATOR

Treatment as Usual

Behavioral: TAU (Treatment as Usual)

Interventions

Mind My Mind BEHAVIORAL

An individual, modular and flexible cognitive and behavioural therapy

MMM (Mind My Mind training)

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.

TAU (Treatment as Usual)

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead
• TrygFonden, Denmark: collaborator
• The Danish Mental Health Foundation: collaborator

Related Publications (24)

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MeSH Terms

Conditions

Anxiety Disorders; Depression; Depressive Disorder; Problem Behavior; Oppositional Defiant Disorder; Conduct Disorder; Mental Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders; Child Behavior; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders

Study Officials

• Pia Jeppesen, Ph.D.

  Child and Adolescent Mental Health Centre, Mental Health Services of the Capital Region of Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D., Senior Researcher and Specialist in Child and Adolescent Psychiatry, and Associate Professor, Institute for Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark

Model Details: No sample size calculation was performed for this parallel, two-arm feasibility RCT. Because the study population was heterogeneous and included children with a broad spectrum of emotional and behavioral mental health problems, 100-120 children were needed in the new experimental MMM arm to answer the research questions related to implementation and acceptability of the MMM manual. Therefore the goal was to include 150 children to be randomly allocated (3:1) to MMM versus TAU. The central, computerized randomization was performed by DEFACTUM using concealed computer-generated allocation sequences with variable block size, and stratification by region (Zealand or Central Denmark), and by age (6-10 years or 11-16 years).

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: February 28, 2018
• Study Start: December 8, 2015
• Primary Completion: April 2, 2017
• Study Completion: April 2, 2017
• Last Updated: February 28, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share