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Mental IllnessNCT02114593

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

A study testing Parent support program in people with Mental Illness, run by Karolinska Institutet at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 11 to 16 years
Conditions the study is for
Mental Illness
What is being tested?
Parent support program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
1 siteSweden
Study dates
Jun 2014to Oct 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Borlänge County

    Borlänge, Dalarna County, 78300

Other trials in Sweden

About this study

Official title: Evaluation of a Parent Support Program to Promote Somali Parent's and Children's Mental Health

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.

Read the 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:

  1. What are the effects of the parenting support program on children's mental health?
  2. What are effects of the parenting support program on parents' mental health and parents' self-efficacy?
  3. 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

Conditions
Mental Illness
Being tested
Parent support program
Keywords
Mental Health, Children, Parent support program, Somali families, Sweden
Medical subject headings
Mental Disorders, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Parent support programBehavioural

    Parent support program

Study groups in NCT02114593
Study groupRoleWhat they receive
Parent support programExperimentalParent support program
Receives: Behavioral: Parent support program
Standard activitiesNo interventionStandard activities

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 months

Secondary outcomes (8)
  1. Parent's mental Health

    General Health Questionnaire GHQ12 will be used to measure parent's mental Health.

    Measured: 2 months

  2. Parent's sense of competence

    Parenting sense of competence,PSOC consists of 16 items to measure efficacy and satisfaction in parenting

    Measured: 2 months

  3. 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.

    Measured: 6 months

  4. Parent's mental health

    General Health Questionnaire GHQ12 will be used to measure parent's mental Health.

    Measured: 6 months

  5. Parent's sense of competence

    Parenting sense of competence (PSOC) consists of 16 items to measure efficacy and satisfaction in parenting.

    Measured: 6 months

  6. 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.

    Measured: 2 months

  7. Client satisfaction

    Client Satisfaction Questionnaire (CSQ) consists of 10 items to assess and evaluate the intervention and parents' view.

    Measured: 2 months

  8. 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionOct 2015
  4. Study completionOct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02114593
Sponsor's protocol ID
Ladnaan123
Other IDs
Dnr 2014/048
Status last verified
Oct 2015
First submitted
12 Apr 2014
Last updated
20 Oct 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 34413097
  • 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.

    PubMed 33892740
  • 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.

    PubMed 29222136

Questions about this trial

What is this clinical trial studying?

A study testing Parent support program in people with Mental Illness, run by Karolinska Institutet at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Children's mental health (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02114593, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2015.

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