Family Empowerment (FAME): A pilot implementation and evaluation.|
|- candidate number||28417|
|- NTR Number||NTR6934|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-jan-2018|
|- Secondary IDs||NL63272.058.17 METC LUMC Protocol |
|- Public Title||Family Empowerment (FAME): A pilot implementation and evaluation.|
|- Scientific Title||Family Empowerment (FAME): A pilot
implementation and evaluation of multi-family
groups as a secondary prevention program for
asylum seeker families.|
|- hypothesis||It is hypothesized that FAME has a positive impact on family functioning and prevents further development of parental symptoms of anxiety and depression.|
|- Healt Condition(s) or Problem(s) studied||Refugees, Secundary prevention, Multi-family groups|
|- Inclusion criteria||To be eligible to participate in this study, a subject must meet the following criteria: |
- At least one caregiver participates (male or female)
- At least one child aged 0-18 will participate
- Living in an asylum center or family location
|- Exclusion criteria||A potential subject who meets any of the following criteria will be excluded from participation in this study: |
- Not being able to function in a group or to profit from participating: (Severe psychiatric illness, such as psychosis; Severe mental challenges; Severe behavioral problems)
- Although participants speaking a different language in the group is not an obstacle to taking part in this study, the limit to the number of interpreters present in one group is three interpreters.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-feb-2018|
|- planned closingdate||1-feb-2019|
|- Target number of participants||60|
|- Interventions||Family Empowerment (FAME) is a secondary prevention program. Both parents and their children living in asylum seeker centers as well as parents and children living in family locations will receive seven sessions of FAME. The sessions are based on group- and systemic therapy (Asen & Scholz, 2010). Each session consists of an energizer: an activity to warm up the participants and promote group interactions. Then the main activity, focused on the theme of the session, will take place. The sessions are ended by reflecting on what the participants discussed and practiced with.
The themes and activities of FAME are based on the metaphor “the bucket and the treasure chest”. The bucket is a metaphor for the number of stressful factors and problems families are exposed to. The bucket is filled with soluble and insoluble problems. The treasure chest on the other hand represents the sources of support of the families. During the program, families and trainers will focus on questions such as: What are sources of stress in the bucket, and what are sources of support in the treasure chest? All sessions aim to support parents in taking care of their children in such difficult times.
A manual on FAME has been published: ‘Goed ouderschap in moeilijke tijden’ (Mooren & Bala, 2016). This manual describes the program for children aged 6 to 12. The program will be further adapted to fit the other age groups.
|- Primary outcome||The main study parameters are the difference in pre- versus post FAME family functioning and parental symptoms of depression/anxiety between the families living in asylum centres and families living in family locations.
Family functioning will be measured using the Systemic Clinical Outcome and Routine Evaluation (SCORE-15; Stratton, Bland, Janes, & Lask, 2010). The SCORE-15 is a self-report questionnaire assessing changes in family relationships. The SCORE includes 19 questions, which take less than 10 minutes to complete. The questionnaire can be used to monitor and report indicators of progress in systemic therapy. It is an overall measure of family functioning as well as ‘sub-scale’ scores on the dimensions: strength and adaptability, overwhelmed by difficulties and disrupted communication. The validity as an index of therapeutic change is established. The questionnaire is acceptable and has strong consistency and reliability (Stratton et al., 2013).
Parental symptoms of depression/anxiety are assessed using the Patient Health Questionnaire for Depression and Anxiety (PHQ-4; Kroenke, Spitzer, Williams, & Löwe, 2009), an ultra-brief screener for depression and anxiety. It can be either self-administered or administered by health care personnel. Reliability and validity of the PHQ-4 were supported by Löwe et al. (2010). Moreover, the authors offer normative data to compare scale scores with a general population reference group.
|- Secondary outcome||What is the difference between families living in asylum centers and those living in family locations?
PHQ-4 & SCORE-15, as described above.
Emotional Availability Scales (EAS) was developed by Biringen, Robinson and Emde (2000). Biringen, Derscheid, Vliegen, Closson, & Easterbrooks (2014) described emotional availability as "the capacity of a dyad to share an emotionally healthy relationship" (p. 114). As both child and caregiver can impact the caregiver-child relationship, EAS addresses both caregiver and child components. EAS measures four caregiver components: sensitivity, structuring, non-intrusiveness and non-hostility. The child components are the child's responsiveness to the caregiver and the child's involvement with the caregiver. A score on a Likert scale of 1-7 on each component will be used for data analysis. A score of 7 suggests that the participant displays optimal behaviors on that scale. A score of 4 indicates inconsistent behavior. Moreover, a score of 1 indicates that the participant displays non-optimal behavior. Studies focusing on the EAS suggest that it is universally applicable. Moreover, an association between EA-scales and parenting, child development and the parent-child relationship is demonstrated in various countries (Selin, 2014). Offers insight in the parent-child relationship in this two different groups.
Can the program be conducted in a naturalistic setting?
To measure whether the program can be executed as intended, a program integrity list (PIL) has been developed. The checklist is based on the four dimensions of program integrity:
- Adherence: specific components of the program (FAME), as described in the manual of FAME (Mooren, & Bala, 2016);
- Exposure: the extent to which family members were exposed to the program (e.g. presence list, duration of the program);
- Quality of delivery: therapeutic skills and competence;
- Participants responsiveness: reactions during the session (e.g. participation, enthusiasm).
An assessor will be present during all the sessions to fill in the program integrity list. The program integrity list will be filled in during the sessions and additional questions about participant responsiveness will be asked during the semi-structured interview. All assessors will be trained in using the program integrity list.
Evaluation of the program
The semi-structured interview focuses on several subjects and has three main aims:
1) To evaluate the experience of participants/professionals involved in the project
2) To evaluate program outcomes: social support, coping strategies, the parent-child relationship
3) To evaluate program integrity
It lasts approximately 30/45 minutes per family member. If needed, an interpreter will be present. Open-ended questions will be posed to the family-members. Then, where possible, family members can score their answers on a 5-point Likert scale. For example: “Which component of the program was most helpful to you, and why?” (open-ended question) “How helpful was this component?” (scoring on a Likert-scale). The researcher will be trained in using the topic list of the semi-structured interview.
The (Young Child) Outcome Rating Scale ((YC)ORS) and (Young Child) Sessions Rating Scale ((YC)SRS) are self-report scales, offering insight in the process of participants. The ORS has four subscales: Individual, Relational, Social and General. The four subscales of the SRS are Relationship, Goals and topics, Approach and method, and Overall. They respectively measure distress of the participant after a session and how session is rated by the participants. This information can be used to understand the process during a program and how participants feel about sessions, thus offering insight in how a program can be improved. Both scales are visual and analogue.
|- Timepoints||Pre- and post FAME. Post-measurements will be planned approximately a week after FAME has finished.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| Carlijn van Es|
|- CONTACT for SCIENTIFIC QUERIES|| Carlijn van Es|
|- Sponsor/Initiator ||Foundation Centrum '45, Foundation Centrum ’45 (part of Arq Psychotrauma Expert Group)|
(Source(s) of Monetary or Material Support)
|- Brief summary||Families applying for asylum have often experienced multiple potentially traumatic events and face continuous stressors, such as a long and complex asylum procedure. Studies have indicated that experiencing traumatizing events can impact parenting behavior and child development (Van Ee, 2012). To target these at-risk families, the prevention program Family Empowerment (FAME) was developed (Mooren & Bala, 2016). This program aims to strengthen parenting skills and prevent further development of emotional problems. This study concerns a pilot implementation and evaluation of FAME.
Country of recruitment: the Netherlands
|- Main changes (audit trail)|
|- RECORD||8-jan-2018 - 11-jan-2018|
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