Clinical trial NCT04804917: 3-year Follow-up of the Mind My Mind RCT
Official title: Long-term Outcome of a Transdiagnostic Cognitive-behavioral Psychotherapy Compared With Management as Usual for Youth With Common Mental Health Problems: a 3-year Follow-up of a Randomized Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emotional Problem
Anxiety Disorder of Childhood
Depressive Symptoms
Behavior Problem of Childhood and Adolescence
Mental Health Disorder
Keywords: Cognitive Behavioral Therapy
Long-term follow-up of RCT
Effectiveness
Transdiagnostic
Children
Adolescents
Youths
Indicated prevention
Personalized treatment
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
Collaborators: name: Frederiksberg University Hospital
name: Defactum, Central Denmark Region
name: The Danish Mental Health Foundation
First posted: 2021-03-18
Enrollment: 396
Sex: ALL
Minimum age (years): 8
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study subjects are the 396 school-aged youths who were identified with indicated need for treatment of anxiety, depressive symptoms, and/or behavioral disturbances and randomized to MMM (n=197) or MAU (n=199).

The parent of each of subject will be invited to answer questionnaires to assess the long-term outcomes.

We will also follow the help-seeking population (n=573) and the age-matched background population in the four municipalities (study sites) by use of data drawn from the Danish National Registries (reference groups).

Brief summary: This is a three-year follow up of a previously completed randomized clinical trial (RCT) of a transdiagnostic cognitive and behavioral (CBT) program ("Mind My Mind" \[MMM\]) compared to management as usual (MAU) in youth with emotional and behavioral problems.

The effectiveness trial (Clinical Trials Identifier: NCT03535805) evaluated an intervention for help-seeking youth with emotional and behavioral health problems below the threshold for referral to specialized treatment. The experimental intervention MMM consisted of 9-13 weekly, individual therapy sessions delivered by psychologists in a non-specialist school-based setting. The CBT-methods were organized in modules for anxiety, depression and/or behavioral problems, and the therapy was completed within 17 weeks. The MAU was enhanced by two care-coordination visits to help coordinate the usual care in the four municipalities in Denmark. The trial was conducted in four diverse municipalities in Denmark.

The aim of this study is to determine the long-term effects of the transdiagnostic, modular CBT program ("Mind My Mind" \[MMM\]) compared to management as usual (MAU).

The three-year follow-up of the RCT of MMM versus MAU is nested in a larger study of help-seeking youth screened for eligibility and stratified into three groups with increasing severity of problems. Youths with an intermediate level of problems were included in the RCT. We screened 573 help-seeking youths, and we included and randomized a total of 396 youths (age 6-16 years, with anxiety, depressive symptoms, and/or behavioral problems) to MMM (n=197) or MAU (n=199).

The study participants comprise the 396 youths and their parents who participated in the RCT. We will use the help-seeking population and the background population in the four municipalities as reference groups.

The follow-up study does not include an intervention. The long-term outcome of MMM versus MAU will be investigated using parent-reported questionnaires administered in average three years after random allocation to intervention. All study participants are followed in the Danish national registries.

Detailed description: Background: Behavioral and cognitive-behavioral therapy (CBT) programs targeting a single class of problems are effective, however, these interventions have not been widely implemented, and the population of youth with common mental health problems is markedly undertreated. This knowledge-practice gap calls for pragmatic trials testing the long-term effectiveness of scalable interventions for common mental health problems among youth.

Objective: This is a three-year follow up of a previously completed, randomized clinical trial (RCT) of a transdiagnostic cognitive and behavioral (CBT) program ("Mind My Mind" \[MMM\]) compared to management as usual (MAU) in youth with emotional and behavioral problems. The RCT (Clinical Trials Identifier: NCT03535805) evaluated a scalable, transdiagnostic intervention for help-seeking youth with emotional and behavioral health problems below the threshold for referral to specialized mental health services.

The specific aim of this follow-up study is to determine the long-term effects of the transdiagnostic and modular CBT program ("Mind My Mind" \[MMM\]) compared to management as usual (MAU). The secondary aim is to conduct a cost-effectiveness analysis of MMM versus MAU.

Design: This long-term follow-up of the MMM versus MAU is nested in a larger observational study of the population of help-seeking youths who were screened for eligibility. We used a stage-based approach to identify youths with mental health problems requiring an intervention and to stratify the youths into three groups with increasing severity of problems. The youth with an intermediate level of emotional and behavioral problems were included in the RCT. The long-term outcome of the two comparison groups in the RCT will be investigated by administration of research questionnaires to the parents, and the total study population will be described by use of register-based data. The combined use of questionnaires and register-based data will minimize problems of attrition.

Setting: Non-specialist school-based settings in four municipalities in Denmark.

Participants: In summary, 573 help-seeking youths (age 6-16 years) and their parents took part in the screening. Seventy-five (13%) had mental health problems below the intervention threshold, 396 (69%) were deemed eligible for the early intervention and included in the RCT, and 52 (9%) had symptoms of severe mental health problems and disorders and were referred to specialized services. Fifty (9%) youth were excluded for other reasons. A total of 396 youths were identified with anxiety, depressive symptoms, and/or behavioral disturbances. This group was included in the RCT and randomized to MMM (n=197) or MAU (n=199). The primary outcome was the impact of mental health problems reported by the parent at week 18, using the Strengths and Difficulties Questionnaire (SDQ) impact scale (range=0-10 points).

The study participants comprise the 396 youths and their parents who participated in the RCT. We will use the help-seeking population and the background population in the four municipalities as reference groups.

Interventions: The follow-up study does not include an intervention. The MMM consisted of 9-13 weekly, individual therapy sessions delivered by local psychologists who received education and weekly supervision in the MMM manual. The CBT methods were organized in modules for anxiety, depression and behavioral problems. Flowcharts described the sequencing and dosing of modules to match the problems at hand, e.g. parent management training for youth's behavioral problems. The therapy was completed within 17 weeks, followed by a booster session after four weeks.

The MAU was enhanced by two care-coordination visits (week 2 and 17) to help access care in the municipality. The MAU interventions included anonymous counseling, pedagogical advice, network meetings, educational support, private or publicly funded psychological treatment, or no treatment.

Outcomes: The long-term outcome of MMM versus MAU will be investigated using parent-reported questionnaires administered in average three years after random allocation to intervention. All study participants are followed in the Danish national registries by linking of individual-level data from several registries. The follow-up will be conducted approximately three years (30-43 months) after the random allocation to intervention in the RCT.

The register-based exploratory outcomes will focus on the youth's use of psychiatric and somatic health care services, academic performance on the national school tests and exams, school absence and wellbeing in school. Regarding use of health care services, we will study the time to the first contact, and the frequency and the pattern of contacts (acute/non-acute, inpatient/outpatient, psychiatric/somatic) during the follow-up period. We will also track activities in the social sector including notifications to the authorities stating a concern for the health and wellbeing of the young person, and preventative interventions to assist the family. Finally, we will study changes in the parents' employment status (including sick leave, part-time work and unemployment) during the follow-up period to assess whether the participation in MMM, relatively to MAU, did influence the life circumstances of the family in a broader sense.

Cost-effectiveness analysis: The evaluation of the cost-effectiveness of the MMM, relative to MAU, will build on our previous cost-utility analysis (CUA) of data from the RCT. The extended follow-up time will reduce the uncertainty around the results by replacing the extrapolation scenarios with repeated assessment of the health-related quality of life measured with the parent-reported questionnaire CHU9D. The analyses of costs will include register-based, individual-level data on the young person's health care utilization in the 3-year follow-up period from the date of randomization, along with the associated unit costs that are listed in administrative registers.

Perspectives: The study will provide new knowledge of the long-term effectiveness of transdiagnostic CBT to lower the burden of mental health disorders in youth.

Eligibility criteria: Inclusion Criteria:

1. Participation in the Mind My Mind RCT (n=396)
2. Written consent by the parent and legal guardian to take part in the 3-year follow-up of the Mind My Mind RCT by answering the web-based questionnaires

Exclusion Criteria:

1) Withdrawal from the follow-up of Mind My Mind RCT (n=63).

Primary outcomes:
measure: The child's impact of mental health problems reported by the parent on the Strengths and Difficulties Questionnaire Impact Scale.
timeFrame: Last month at 3-year follow-up
Secondary outcomes:
measure: Emotional and behavioral problems
timeFrame: Last month at 3-year follow-up
measure: School attendance: proportion of school-days within the last 4 weeks, where the child is present (no illegal absence)
timeFrame: Last four weeks at 3-year follow-up
measure: Child Health Utility instrument (CHU9D)
timeFrame: The present day at 3-year follow-up
measure: The Parental Stress Scale (PSS)
timeFrame: Present time at 3-year follow-up
Other outcomes:
measure: The number of participants who responded defined as a SDQ Impact score reduction ≥1 points
timeFrame: at 3-year follow-up
measure: The number of participants in remission defined as SDQ algorithm scores below cut-off for need of treatment
timeFrame: at 3-year follow-up
measure: Psychosocial treatments
timeFrame: Last three months at 3-year follow-up
measure: The impact of child's mental health problems on the parent's ability to work
timeFrame: Last four weeks at 3-year follow-up
measure: Parent-reported unmet needs
timeFrame: Present time at 3-year follow-up
measure: Use of health care services
timeFrame: Time period from randomization to June 30, 2021
measure: Use of psychotropic drugs
timeFrame: Time period from randomization to June 30, 2021
measure: School attendance
timeFrame: Time period from end of intervention (week 18) to June 30, 2021
measure: School performance
timeFrame: Time period from end of intervention (week 18) to June 30, 2021
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.
citation: Wolf RT, Puggaard LB, Pedersen MMA, Pagsberg AK, Silverman WK, Correll CU, Plessen KJ, Neumer SP, Gyrd-Hansen D, Thastum M, Bilenberg N, Thomsen PH, Jeppesen P. Systematic identification and stratification of help-seeking school-aged youth with mental health problems: a novel approach to stage-based stepped-care. Eur Child Adolesc Psychiatry. 2022 May;31(5):781-793. doi: 10.1007/s00787-021-01718-5. Epub 2021 Jan 18.
citation: Wolf RT, Ratcliffe J, Chen G, Jeppesen P. The longitudinal validity of proxy-reported CHU9D. Qual Life Res. 2021 Jun;30(6):1747-1756. doi: 10.1007/s11136-021-02774-9. Epub 2021 Feb 13.