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Affective Dysregulation in Childhood – Optimizing Prevention and Treatment (ADOPT): Efficacy of a personalized modular outpatient treatment program to treat affective dysregulation and comorbid disorders in out-of-home care children.

Affective Dysregulation in Childhood – Optimizing Prevention and Treatment (ADOPT): Efficacy of a personalized modular outpatient treatment program to treat affective dysregulation and comorbid disorders in out-of-home care children. - ADOPT Institution

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00014581
Enrollment
220
Registered
2018-07-04
Start date
2018-10-04
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Affective Dysregulation F 34.8 (DSM-V): Disruptive mood dysregulation disorder

Interventions

Group 1: Modular Outpatient Treatment of Affective Dsyregulation and coexisting disorders (PeMOT-AD
9 moths, 24 sessions in total): The program is leaned on evidence-based cognitive-behavoral therapy (CBT) programs (e.g. Coping Power Program, Cognitive-behavioral Therapy for Anger and Aggression in
control group
9 months): The treatment will follow accepted guidelines and regular treatment schemes, and will take place in the institutes outpatient clinics or with outpatient practitioners (psychiatrists or psyc

Sponsors

Universitätsklinik Ulm
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 12 Years

Inclusion criteria

Inclusion criteria: age between 8;0 and 12;11 years; living in out-of-home care; clinician-rated AD symptoms > cut-off (OMAD)

Exclusion criteria

Exclusion criteria: IQ <80; severe mental disorder (profound developmental disorder, schizophrenia, psychosis, bipolar disorder, obsessive compulsive disorder) causing AD symptoms; insufficient language skills of child and/or caregiver; intensive psychotherapy (ongoing or planned)

Design outcomes

Primary

MeasureTime frame
AD-symptoms: To assess symptoms of affective dysregulation, a newly developed clinician-rated interview (Outcome Measure for Affective Dysregulation: OMAD) to evaluate caregiver (in this sub-project foster parents or child care workers from youth welfare institutions) information about the child will be used. The assessments will take place immediately before starting the treatment (T1) and immediately after closing it (T2), as well as 8 months after that (T3). The rating of the clinician and the assignment to treatment arms will be conducted independently (blinded rating). The interviews will be audiotaped; 10% of them will be evaluated by a second rater (interrater-reliability).

Secondary

MeasureTime frame
Clinician-rated AD symptoms (children, caregivers, teachers; OMAD), ADHD and conduct disorders (DISYPS-III), other comorbid disorders (CBCL 6-18R; TRF 6-18R), psychological wellbeing oft he child (KIDSCREEN), clinician-rated psychosocial impairment of the child (DISYPS-III). All secondary endpoints will be assessed at T1, T2 and T3.

Countries

Germany

Contacts

Public ContactMarion Steiner

Universitätsklinikum Ulm, Klinik für Kinder- und Jugendlichenpsychiatrie/Psychotherapie

adopt.studie@uniklinik-ulm.de0731 500-62665

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 2, 2026