Improve-MH: Improving mental health in refugee families with young children

Improve-MH: Improving mental health in refugee families with young children - IMPROVE-MH

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00019072

Enrollment

188

Registered

2020-03-16

Start date

2021-05-28

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

F41 F32 F43 F33 F40

Interventions

Group 1: Intervention: Parents will receive a 10-week intervention with 1) a treatment in the general practice (learning to cope with depression, stress and anxiety), 2) a well-established online trai

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: (1) Refugee parents (2) child(ren) under the age of 7 years (3) Arabic, German or English language skills (4) meeting clinical cut-off on Depression Anxiety Stress Scales (DASS-21)

Exclusion criteria

Exclusion criteria: Key exclusion criteria: (1) other primary mental health problems (2) concurrent psychotherapy (3) (instable) intake of relevant medication (neuroleptic drugs, instable anticholinergic, or instable antiepileptic drugs) (4) acute psychosis (5) acute suicidality (6) general medical contraindications Comorbid mental health problems are not a criterion for exclusion as long as they are not primary.

Design outcomes

Primary

Measure	Time frame
Primary outcomes are parenting style and the mental health of parents and their child. - Parenting Scale (EFB-K): Original version by Arnold, Leary, Wolff, and Acker (1993), German short version by Miller (2001), our own Arabic translation is oriented on the German short version. - Parental mental health: Severity Rating of the parent´s mental health problems on a 0–8 scale (Clinician Severity Rating, Mini-DIPS, by Margraf, J., Cwik, J. C., Pflug, V., & Schneider, S. (2017)). - Child mental health: Severity Rating of the children’s mental health problems on a 0–8 scale (Clinician Severity Rating, Baby/Kinder-DIPS, hybrid version of the Baby- (Popp et al., 2016) and Kinder-DIPS (Neuschwander et al., 2017)). All primary outcomes will be assessed pre (T0), post (T1) and 3- (T2) and 6-months (T3) follow-up. Mixed models will be used to compare the degree of change from pre (T0) to post (T1) and follow-up (T2, T3) assessments between groups on primary outcomes, and to examine covariates.	—

Measure

Time frame

Primary outcomes are parenting style and the mental health of parents and their child. - Parenting Scale (EFB-K): Original version by Arnold, Leary, Wolff, and Acker (1993), German short version by Miller (2001), our own Arabic translation is oriented on the German short version. - Parental mental health: Severity Rating of the parent´s mental health problems on a 0–8 scale (Clinician Severity Rating, Mini-DIPS, by Margraf, J., Cwik, J. C., Pflug, V., & Schneider, S. (2017)). - Child mental health: Severity Rating of the children’s mental health problems on a 0–8 scale (Clinician Severity Rating, Baby/Kinder-DIPS, hybrid version of the Baby- (Popp et al., 2016) and Kinder-DIPS (Neuschwander et al., 2017)). All primary outcomes will be assessed pre (T0), post (T1) and 3- (T2) and 6-months (T3) follow-up. Mixed models will be used to compare the degree of change from pre (T0) to post (T1) and follow-up (T2, T3) assessments between groups on primary outcomes, and to examine covariates.

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Secondary

Measure	Time frame
Secondary endpoints are parenting sense of competence (PSOC), parental mental health (DASS-21, PMH, SDS-RI, GSR, RHS-15, selection and assessment of major complaints) and child mental health (Kiddy-Kindl, SDQ, selection and assessment of major problems in parenting), and parental physical health (EQ5D5L) as well as child physical health (WCHMP). In addition, psychosocial variables (trauma events (HTQ), acculturation and language skills (AQ and self-assessment of language skills using the European Framework of Reference for Languages), housing conditions, employment status, quality of life (cantril ladder), partnership satisfaction (PFB), social support, treatment expectations) are assessed. After the Improve-Intervention (post), the parents also give a feedback on the satisfaction with the Improve-treatment (self-generated questions and CSQ). The data will be collected using questionnaires. Hair cortisol will be assessed as an additional biological stress-marker pre and six-months follow up (Major Assessment). During the intervention (immediately after the treatment in the Improve-program or in parallel in the treatment as usual, respectively), global health changes (GSR), changes in main complaints, mental health problems (DASS-21) and and parenting style (EFB-K) will be assessed (Minor Assessment). Beside questions regarding the parenting program, global health changes (GSR), disability (SDS-RI) and possible side effects of the treatment will be assessed during weekly phone calls (Intermediate assessment). - Parenting Sense of Competence (PSOC): The original version was developed by Gibaud-Wallston and Wandersman (1978) for the parents of infants and adapted by Johnston & Mash (1989) for parents of older children. German version by Miller (2001), Arabic version by Kabiyea and Manor-Binyamini (2019). - Depression Anxiety and Stress Scale (DASS-21): Original version by Lovibond and Lovibond (1995), German short version by Nilges and Essau (2015), Arabic ver	—

Measure

Time frame

Secondary endpoints are parenting sense of competence (PSOC), parental mental health (DASS-21, PMH, SDS-RI, GSR, RHS-15, selection and assessment of major complaints) and child mental health (Kiddy-Kindl, SDQ, selection and assessment of major problems in parenting), and parental physical health (EQ5D5L) as well as child physical health (WCHMP). In addition, psychosocial variables (trauma events (HTQ), acculturation and language skills (AQ and self-assessment of language skills using the European Framework of Reference for Languages), housing conditions, employment status, quality of life (cantril ladder), partnership satisfaction (PFB), social support, treatment expectations) are assessed. After the Improve-Intervention (post), the parents also give a feedback on the satisfaction with the Improve-treatment (self-generated questions and CSQ). The data will be collected using questionnaires. Hair cortisol will be assessed as an additional biological stress-marker pre and six-months follow up (Major Assessment). During the intervention (immediately after the treatment in the Improve-program or in parallel in the treatment as usual, respectively), global health changes (GSR), changes in main complaints, mental health problems (DASS-21) and and parenting style (EFB-K) will be assessed (Minor Assessment). Beside questions regarding the parenting program, global health changes (GSR), disability (SDS-RI) and possible side effects of the treatment will be assessed during weekly phone calls (Intermediate assessment). - Parenting Sense of Competence (PSOC): The original version was developed by Gibaud-Wallston and Wandersman (1978) for the parents of infants and adapted by Johnston & Mash (1989) for parents of older children. German version by Miller (2001), Arabic version by Kabiyea and Manor-Binyamini (2019). - Depression Anxiety and Stress Scale (DASS-21): Original version by Lovibond and Lovibond (1995), German short version by Nilges and Essau (2015), Arabic ver

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Countries

Germany

Contacts

Public ContactKerstin Konietzny

Ruhr-Universität Bochum Forschungs- und Behandlungszentrum für psychische Gesundheit (FBZ) Klinische Kinder- und Jugendpsychologie Fakultät für Psychologie

kerstin.konietzny@rub.de0234-3221507

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026