NCT02114593

Brief Summary

The aim of this project is to evaluate the effectiveness of a culturally adapted parenting support program for Somali parents living in Sweden on children's and parent´s mental health. In recent years the Somali population in Sweden has increased and is currently one of the largest groups among ethnic minorities. Most of the Somali people have arrived as refugees and have experienced war, trauma and conflict. Research shows that migration to a new social context/society is challenging for a family and may together with previous experiences of war, separation, create stress and mental illness. This leads to consequences such as family violence, child abuse, relational problems, drug problems and school problems for children. There is a vast knowledge on the association between parents' mental health, positive parent-child relationship and children's health and well-being. Previous studies have shown that parenting programs aimed to support parent-child relationship and/or improve parental skills have positive effects on parental mental health and on children's behavior. Most municipalities in Sweden offer their residents a structured parenting program, but these programs do not reach those of ethnic minorities. Studies show that parenting programs mainly target parents who can speak Swedish fluently and that the parenting programs are not yet culturally adapted.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 15, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 20, 2015

Status Verified

October 1, 2015

Enrollment Period

1.3 years

First QC Date

April 12, 2014

Last Update Submit

October 17, 2015

Conditions

Mental Illness

Keywords

Mental HealthChildrenParent support programSomali familiesSweden

Outcome Measures

Primary Outcomes (1)

  • Children's mental health

    Child Behavior Checklist, CBCL is a validated instrument for measuring emotional and behavior problems among children. This instrument will be answered by parents.

    2 months

Secondary Outcomes (8)

  • Parent's mental Health

    2 months

  • Parent's sense of competence

    2 months

  • Children's mental health

    6 months

  • Parent's mental health

    6 months

  • Parent's sense of competence

    6 months

  • +3 more secondary outcomes

Study Arms (2)

Parent support program

EXPERIMENTAL

Parent support program

Behavioral: Parent support program

Standard activities

NO INTERVENTION

Standard activities

Interventions

Parent support programBEHAVIORAL

Parent support program

Parent support program

Eligibility Criteria

Age11 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Somali born parent
  • Parent with children in Sweden and in the age 11-16 years old
  • Parent with self-perceived stress about parenting

You may not qualify if:

  • parent who is already participating in a parenting program
  • Parent with psychiatric disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Borlänge County

Borlänge, Dalarna County, 78300, Sweden

Location

Related Publications (3)

  • Osman F, Vixner L, Flacking R, Klingberg-Allvin M, Schon UK, Salari R. Impact of a culturally tailored parenting programme on the mental health of Somali parents and children living in Sweden: a longitudinal cohort study. BMJ Open. 2021 Aug 19;11(8):e045067. doi: 10.1136/bmjopen-2020-045067.

    PMID: 34413097DERIVED

  • Nystrand C, Sampaio F, Hoch JS, Osman F, Feldman I. The cost-effectiveness of a culturally tailored parenting program: estimating the value of multiple outcomes. Cost Eff Resour Alloc. 2021 Apr 23;19(1):23. doi: 10.1186/s12962-021-00278-4.

    PMID: 33892740DERIVED

  • Osman F, Salari R, Klingberg-Allvin M, Schon UK, Flacking R. Effects of a culturally tailored parenting support programme in Somali-born parents' mental health and sense of competence in parenting: a randomised controlled trial. BMJ Open. 2017 Dec 7;7(12):e017600. doi: 10.1136/bmjopen-2017-017600.

    PMID: 29222136DERIVED

MeSH Terms

Conditions

Mental DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Marie Klingberg-Allvin, Ass. Prof.

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 12, 2014

First Posted

April 15, 2014

Study Start

June 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

October 20, 2015

Record last verified: 2015-10

Locations

SE(1)