3-year Follow-up of the Mind My Mind RCT

NCT04804917 | Completed

• 1 other identifier: MHSCRDenmark, F-61502-03-1
• Study Type: observational
• Target: 396
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Emotional and behavioral problems

  Last month at 3-year follow-up

• School attendance: proportion of school-days within the last 4 weeks, where the child is present (no illegal absence)

  Last four weeks at 3-year follow-up

• Child Health Utility instrument (CHU9D)

  The present day at 3-year follow-up

• The Parental Stress Scale (PSS)

  Present time at 3-year follow-up

Other Outcomes (9)

• The number of participants who responded defined as a SDQ Impact score reduction ≥1 points

  at 3-year follow-up

• The number of participants in remission defined as SDQ algorithm scores below cut-off for need of treatment

  at 3-year follow-up

• Psychosocial treatments

  Last three months at 3-year follow-up

Study Arms (1)

Participants in the MindMyMind RCT

The study participants comprise the 396 youths (and their parents) who participated in the Mind My Mind RCT. The study participants were randomized to the experimental MMM intervention (n=197) or MAU (n=199) and followed in the trial until 26 weeks after randomization, from September 7, 2017, to August 28, 2019. The MMM consisted of 9-13 weekly, individual therapy sessions. 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. 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). The MAU interventions included anonymous counseling, pedagogical advice, network meetings, educational support, psychological treatment, or no treatment.

Eligibility Criteria

• Age: 8 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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).

You may qualify if:

• Participation in the Mind My Mind RCT (n=396)
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead
• Frederiksberg University Hospital: collaborator
• Defactum, Central Denmark Region: collaborator
• The Danish Mental Health Foundation: collaborator

Study Sites (1)

Mental Health Services in the Capital Region, Denmark

Copenhagen, DK-2900, Denmark

Location

Related Publications (3)

• 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.

  PMID: 33355633 RESULT

• 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.

  PMID: 33459884 RESULT

• 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.

  PMID: 33582966 RESULT

MeSH Terms

Conditions

Depression; Mental Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Pia Jeppesen, PhD

  Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate clinical professor, PhD,

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 18, 2021
• Study Start: March 22, 2021
• Primary Completion: August 31, 2021
• Study Completion: September 17, 2021
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)