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Ladnaan - an Evaluation of a Parent Support Program for Somali Parents

Primary Purpose

Mental Illness

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Parent support program
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mental Illness focused on measuring Mental Health, Children, Parent support program, Somali families, Sweden

Eligibility Criteria

11 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Borlänge County

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Parent support program

Standard activities

Arm Description

Parent support program

Standard activities

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Parent's mental Health
General Health Questionnaire GHQ12 will be used to measure parent's mental Health.
Parent's sense of competence
Parenting sense of competence,PSOC consists of 16 items to measure efficacy and satisfaction in parenting
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 Children.
Parent's mental health
General Health Questionnaire GHQ12 will be used to measure parent's mental Health.
Parent's sense of competence
Parenting sense of competence (PSOC) consists of 16 items to measure efficacy and satisfaction in parenting.
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 Children.
Client satisfaction
Client Satisfaction Questionnaire (CSQ) consists of 10 items to assess and evaluate the intervention and parents' view.
Children's mental health
Child Behavior Checklist, CBCL is a validated instrument for measuring emotional and behavior problem among children. The instrument will be answered by parents.

Full Information

First Posted
April 12, 2014
Last Updated
October 17, 2015
Sponsor
Karolinska Institutet
Collaborators
Dalarna University
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1. Study Identification

Unique Protocol Identification Number
NCT02114593
Brief Title
Ladnaan - an Evaluation of a Parent Support Program for Somali Parents
Official Title
Evaluation of a Parent Support Program to Promote Somali Parent's and Children's Mental Health
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Dalarna University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
In recent years the Somali population in Sweden has increased and is currently one of the largest groups among ethnic minorities in Sweden (http://www.scb.se). Most of the Somali people living in Sweden have arrived as refugees and they 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 mental ill-health (Bhugra, 2004; FoU, 2008). According to several studies, refugee families have poorer health and low social status compared to the native Swedish (Bhugra, 2004). Previous studies reported that both parents and children who have experienced war and conflict suffer from stress and are at risk for mental ill-health. This stress leads to various consequences such as family violence, child abuse, relational problems between parents and children, drug problems and school problems for children (Ajdukovic, et al., 1993; James, 1997; Schimtz, et al., 2003). Experience of war and conflict has further shown to have a negative impact on parent's ability to care for their children (Jack, 2000). There is a vast knowledge on the association between parents' mental health, positive parent-child relationship and children's health and well-being (e.g. Bremberg, 2002). 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 (Lindsay et al., 2011; Bjorknes et al., 2013; Stewart-Brown et al., 2011). For example, parents who have participated in parenting programs report feeling less worried, stressed and depressed (Lindsay, et al., 2011; Marcynyszyn, et al., 2011, Phelan, et al., 2012; Stewart-Brown, et al., 2004). Hence, by supporting parents in their role as parents, improvements can be seen in both parents' and children's health and well-being. According to the Swedish governmental national strategy, parents should be offered support and knowledge on how to strengthen their parenting role (Reports, 2008). Almost all the municipalities in Sweden offer their residents a structured parenting program. However, these parenting programs do not reach all residents in the municipalities, especially those of ethnic minorities (Fabian, et al., 2006; Fabian, et al., 2004), due to language barriers and lack of information about existing parenting programs to the ethnic minorities. Studies show that parenting programs mainly target parents who can speak Swedish fluently and that the parenting programs are not culturally adapted (Kling, et al., 2010). Other international studies emphasize that single or young parents, families with low socioeconomic status or who live in deprived areas, have low attendance and high drop out of parenting program (Byrne, et al., 2013; Stewart-Brown, et al., 2011). Attempts have been made to culturally adapt parenting programs both in USA, Australia and in Norway. According to (Cardona et al., 2012) cultural adaptation needs to comprise aspects of language, culture and context. In a study by Bjorknes, et al. ( 2013), the cultural adaptation made included not to have mixed groups with both mothers and fathers and to deliver the parenting program with help the of "link workers" of Somali and Pakistani background. While many Somali parents in Sweden do not attend or have no information about the parenting programs that exist in their municipality, the number of participating families might increase substantially if these programs are offered in Somali and are culturally adapted to Somali families' needs. Aim The aim of the study is to evaluate the effectiveness of a parenting support program on parents' and children's mental health. Research questions: What are the effects of the parenting support program on children's mental health? What are effects of the parenting support program on parents' mental health and parents' self-efficacy? What is the cost effectiveness of the intervention? Methodological approach: A randomized controlled trial will be conducted with one intervention group (i.e. provision of the Connect parenting program) and one control group (i.e. 'usual activities) consisting of Somali parents living in Borlänge Municipality. When applicable, both parents will be randomized together as one family. Intervention: the intervention consists of Connect, an already established and scientifically evaluated parent program. The program is based on attachment theory and focuses on the needs of the child/youth and the parent from an attachment perspective. Connect is a 10 week program, which addresses nine different principles on child development, parent-child relationship and challenging interaction. Parents meet together in small groups with a maximum of eight families together with group leaders for one hour sessions each week. In relation to this, parents are offered some beverages and snacks half an hour before the session. Both parents will be invited to the parenting program participation. The intervention will be held in Somali language by group leaders of Somali background. In total eight group leaders will be recruited and receive four days of Connect training course by Connect instructors. Instructors will give also mentorship during parenting program. The program will be proceeded by two sessions (6 hours) on cultural specific challenges, which will be based on the results from the qualitative study (I). Setting and data collection: Parents will be recruited from the Social services and Somali associations in Borlänge. Several information meetings will be held in different facilities within the social services and Somali associations. Parents who are eligible and give their consent to participate will be asked to fill in the baseline data. Baseline data will be collected before randomization. The intervention will be evaluated by a semi-structured questionnaire. Outcome measures will be collected two and six months after the program has ended in the intervention group, with similar data collection times in the control group. The questionnaires will be translated into the Somali language. They will be filled out by the same parent throughout the study. If both parents participate the intervention their data will pooled if their answer is about the same child. The questionnaires will be answered at a time and location chosen by parents/children, during whom a Somali speaking researcher/person will be present in order to support parents/children in filling out the questionnaires if problems arise (e.g. when parents are illiterate). Outcomes: Primary outcome is improved children's mental health. Secondary outcomes are, improved parents' mental health, and parents' self-efficacy. The questionnaire will include information about the socio-demographic factors and is based on validated instruments. Sample size and analyzes: A power analysis was conducted to determine the required sample size. When comparing two independent sample means, with alpha set at 0.05, and power at 0.80, we need a total sample of 128 children (I: 64 C: 64) to detect a medium difference (d =.5). These groups will be expanded to 75 per group (a total sample of 150 children) since we expect 20% loss during the follow up. Intention-to-treat will be used. This means that analyses will include all randomized parents in the groups to which they were randomly assigned, regardless of their adherence with the entry criteria, regardless of the treatment they actually received, and regardless of subsequent withdrawal from treatment or deviation from the protocol. The specific statistical analysis used with each outcome variable will be determined by the distribution of the outcome variables. Intergroup comparison will be made between the control group and intervention group. Significance A number of studies show that many evidence-based parenting programs improve parental skills and parental mental well-being. Parents perceived to be less stressed, depressed and that they have more confident in their parenting role after undergoing parenting program. By evaluating the effectiveness of a culturally appropriate parenting program to Somali parents living in Sweden the project is attempting to contribute to the wellbeing of both children and parents with Somali background. The result will be used to inform stakeholders and policy makers and hopefully be used in other municipalities in Sweden. Furthermore, the results will be disseminated through international conferences and publication in international open-access journals

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Illness
Keywords
Mental Health, Children, Parent support program, Somali families, Sweden

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parent support program
Arm Type
Experimental
Arm Description
Parent support program
Arm Title
Standard activities
Arm Type
No Intervention
Arm Description
Standard activities
Intervention Type
Behavioral
Intervention Name(s)
Parent support program
Intervention Description
Parent support program
Primary Outcome Measure Information:
Title
Children's mental health
Description
Child Behavior Checklist, CBCL is a validated instrument for measuring emotional and behavior problems among children. This instrument will be answered by parents.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Parent's mental Health
Description
General Health Questionnaire GHQ12 will be used to measure parent's mental Health.
Time Frame
2 months
Title
Parent's sense of competence
Description
Parenting sense of competence,PSOC consists of 16 items to measure efficacy and satisfaction in parenting
Time Frame
2 months
Title
Children's mental health
Description
Child Behavior Checklist, CBCL is a validated instrument for measuring emotional and behavior problems among children. This instrument will be answered by Children.
Time Frame
6 months
Title
Parent's mental health
Description
General Health Questionnaire GHQ12 will be used to measure parent's mental Health.
Time Frame
6 months
Title
Parent's sense of competence
Description
Parenting sense of competence (PSOC) consists of 16 items to measure efficacy and satisfaction in parenting.
Time Frame
6 months
Title
Children's mental health
Description
Child Behavior Checklist, CBCL is a validated instrument for measuring emotional and behavior problems among children. This instrument will be answered by Children.
Time Frame
2 months
Title
Client satisfaction
Description
Client Satisfaction Questionnaire (CSQ) consists of 10 items to assess and evaluate the intervention and parents' view.
Time Frame
2 months
Title
Children's mental health
Description
Child Behavior Checklist, CBCL is a validated instrument for measuring emotional and behavior problem among children. The instrument will be answered by parents.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Somali born parent Parent with children in Sweden and in the age 11-16 years old Parent with self-perceived stress about parenting Exclusion Criteria: parent who is already participating in a parenting program Parent with psychiatric disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Klingberg-Allvin, Ass. Prof.
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Borlänge County
City
Borlänge
State/Province
Dalarna
ZIP/Postal Code
78300
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
34413097
Citation
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.
Results Reference
derived
PubMed Identifier
33892740
Citation
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.
Results Reference
derived
PubMed Identifier
29222136
Citation
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.
Results Reference
derived

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Ladnaan - an Evaluation of a Parent Support Program for Somali Parents

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