Depressive Symptoms Clinical Trial
— MindMyMindFUOfficial 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
Verified date | March 2023 |
Source | Mental Health Services in the Capital Region, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 396 |
Est. completion date | September 17, 2021 |
Est. primary completion date | August 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 20 Years |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Denmark | Mental Health Services in the Capital Region, Denmark | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Mental Health Services in the Capital Region, Denmark | Defactum, Central Denmark Region, Frederiksberg University Hospital, The Danish Mental Health Foundation |
Denmark,
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 — View 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 hea — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | The number of participants who responded defined as a SDQ Impact score reduction =1 points | Response was defined as a one-point reduction on the parent-reported impact scale from baseline to follow-up | at 3-year follow-up | |
Other | The number of participants in remission defined as SDQ algorithm scores below cut-off for need of treatment | To define the threshold for a child's need of treatment (inclusion in the RCT) we developed and validated the following SDQ algorithm: parent-reported SDQ total-difficulties score =14, emotional problems =5, and/or conduct score =3; combined with a functional impairment score =1. This algorithm defined the cut-off for problems above the 90-percentile of mental health problems in the general age-matched population.
Remission was defined as SDQ-algorithm scores below the threshold that indicate need of treatment. |
at 3-year follow-up | |
Other | Psychosocial treatments | Parent-reported questionnaire about the psychosocial treatment and support that their child received in the school-, social-, health-, and private sectors. | Last three months at 3-year follow-up | |
Other | The impact of child's mental health problems on the parent's ability to work | Parent-reported questionnaire about managing their own obligations at work or in an education, eg arriving late, going home early, taking sick leave. | Last four weeks at 3-year follow-up | |
Other | Parent-reported unmet needs | Parent-reported questionnaire about the current mental health problems and unmet needs of their child. | Present time at 3-year follow-up | |
Other | Use of health care services | Individual-level data retrieved from the Danish National Patient Register containing information about contacts with the health care system during the follow-up period. Data is collected routinely in the Danish health care system, independent of the present study. Contacts with the health care system will be assessed and compared as incidence rates of acute/non-acute, in-patient/outpatient and psychiatric/somatic contacts. | Time period from randomization to June 30, 2021 | |
Other | Use of psychotropic drugs | Individual-level data retrieved from the Danish National Drug Database containing information about redeemed prescriptions. Data is collected routinely and independent of this study. Incident use and duration of use of the following psychotropic drugs described by ATC codes (including subgroups contained in the codes) will be studied: C02AC02, N03AE, N05A, N05BA, N05CH, N06A, N06BA, N05CF. | Time period from randomization to June 30, 2021 | |
Other | School attendance | Individual-level data retrieved from the Danish Ministry of Education. Data is collected routinely and independent of this study. School attendance consists of several factors: a) the type of schooling that the child/youth is currently attending, and b) the frequency and proportion of school time the child/youth is registered as not attending. The data quality will be affected by the Covid-19 pandemic school shutdowns, meaning that we may have to omit this outcome. | Time period from end of intervention (week 18) to June 30, 2021 | |
Other | School performance | Individual-level data retrieved from the Danish Ministry of Education. Data is collected routinely and independent of this study. Scores from either a national test of academic performance in Danish or mathematics (one offered at most levels in primary school) in the follow-up period. The score will be assessed with external reference (e. g. national average) as well as relatively among their own peers (e. g. scores divided in tertiles/quartiles). Also, available information on non-attendance at the school tests and exams is considered a relevant outcome, assessed as a frequency and proportional outcome. The data quality will be affected by the Covid-19 pandemic school shutdowns, meaning that we may have to omit this outcome. | Time period from end of intervention (week 18) to June 30, 2021 | |
Primary | The child's impact of mental health problems reported by the parent on the Strengths and Difficulties Questionnaire Impact Scale. | The parent-reported Strengths and Difficulties Questionnaire (SDQ) Impact Scale is scored from 0 to 10 (1, 2, 3, 4, 5, 6, 7, 8, 9, 10) with higher scores indicating more impact of mental health problems.
The minimum relevant difference in impact of mental health problems measured by the SDQ Impact Scale was set at 1.0 corresponding to a change from severe to moderate, or from moderate to little-or-no impact in one of the five domains of child's life (distress, home-life, friendships, classroom learning and leisure activities). The SDQ Impact was previously measured at week 0, 2, 4, 6, 8, 10, 12, 14, 18 and 26 asking about the last six months at baseline and asking about the last month at each follow-up. |
Last month at 3-year follow-up | |
Secondary | Emotional and behavioral problems | The 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 total difficulties scale consists of 20 items, and the sum is calculated (range 0-40) to measure the emotional and behavioral difficulties across the first four problem areas. Higher scores indicate more severity of problems. The parent-reported total difficulties score was measured at week 0, 18 and 26 asking about the last six months at baseline and asking about the last month at week 18 and 26. | Last month at 3-year follow-up | |
Secondary | School attendance: proportion of school-days within the last 4 weeks, where the child is present (no illegal absence) | Parent reported measures of different kinds of school absence | Last four weeks at 3-year follow-up | |
Secondary | Child Health Utility instrument (CHU9D) | The Child Health Utility instrument (CHU9D) measures the health-related quality of life (QoL) in nine domains. The measure is developed specifically for use among children and adolescents. The CHU9D has nine items with five levels of severity in the domains: worried, sad, pain, tired, annoyed, schoolwork/homework, sleep, daily routine and activities. The raw scores range from 9 to 35, with 9 indicating the highest possible QoL and 35 indicating the poorest QoL. The scores can be converted to utilities ranging 0-1 on the dead-full health QALY scale, using preference-based scoring algorithms. The CHU9D is a validated measure of health-related quality of life for use in youth mental health trials.
The parent-reported CHU9D was previously measured at week 0, 18 and 26 asking about the present day. |
The present day at 3-year follow-up | |
Secondary | The Parental Stress Scale (PSS) | The Parental Stress Scale (PSS) is a parent-reported questionnaire with 18 items, scored on a five-point scale (strongly disagree =1, disagree=2, disagree or agree=3, agree=4, strongly agree=5) for each of the eight positively and ten negatively worded items. The scores of the eight positive items are reversed when coding the PSS, and a single parental stress sum is calculated (range 0-72) with higher scores indicating more parental stress. The PSS measures the stress a parent experiences in the role functioning as parent. The instrument has been validated in Denmark.
The PSS score was measured at week 0, 18 and 26 asking the parent of the present time (no explicit time frame) |
Present time at 3-year follow-up |
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