Berger 2011.

Study characteristics
Methods	Study design: RCT Study grouping: parallel group Unit of randomisation: individuals Power (power sample size calculation, level of power achieved): not specified Imputation of missing data: not specified
Participants	Country: Israel Setting: well baby clinics Age: mean = 48.5 (SD = 7.26) years Sample size (randomised): 80 Sex: 80 women Comorbidity (mean (SD) of respective measures in indicated, if available at baseline): baseline results for secondary traumatisation factors (ProQOL scale) compared to norms based on 2 large‐scale studies, of CP samples and MHCPs in the USA: higher levels of compassion fatigue (22.5% in this sample vs 13% in CP and 13.2% in the MHCP) and burnout (32.5% in this sample vs 23% in CP and 13% in MHCP) and higher levels of lack of compassion satisfaction (68.7% in this sample vs 37.0% in CP and 39.3% in MHCP) Population description: 90 well baby clinic nurses living under chronic threat of war and terror; from the most affected areas in the north and the south of Israel Inclusion criteria: not specified Exclusion criteria: not specified Attrition (withdrawals and exclusions): not specified Reasons for missing data: not specified
Interventions	Intervention: well baby clinic staff preparedness programme (n = 42) delivery: face‐to‐face; group sessions (15 ‐ 20 nurses); each session: included theoretical knowledge of various topics, experiential exercises where the examples from the nurses’ work or personal life experience were shared, learned skills which were practised during the session and homework assignments in‐between sessions providers: not specified duration of treatment period and timing: 12 weekly 6‐hour sessions; homework assignments between sessions; three x 5‐hour supervision sessions held monthly after the intervention description: SESSION 1 – Identifying personal resources: establishing a safe and secure atmosphere, setting goals and expectations and identifying WBC nurses’ personal resource profiles. Nurses' tasks: observe and monitor one's own coping strategies at home and in the clinic SESSION 2 – Strengthening and learning new coping skills: learning how to strengthen their natural resources as well as acquiring new sensory‐motor, cognitive and emotional coping skills in deficient areas. Nurses' tasks: practise the new skills at home and in the clinic with the parents SESSION 3 – Attachment theory and child‐parent relationship: overview of attachment theory including normative and abnormal transitions based on research and current developmental theories. Nurses' tasks: observe and monitor distressed children at home and in the clinic SESSION 4 – The phenomenology of traumatised young children: overview of stressful and traumatised infants and toddlers with a focus on developmental issues, child‐parent relationships and attachment patterns. Nurses' tasks: observe and monitor distressed children at home and in the clinic SESSION 5 – Establishing safety and security for young children: learning how to help parents foster a safe and secure environment for their children, particularly during stressful and traumatic periods. Nurses' tasks: instruct and demonstrate safety‐inducing techniques to parents SESSION 6 – Assisting parents to stabilise and soothe young children: learning how to teach parents relaxation and affect‐modulation strategies for distressed infants and children. Nurses' tasks: practise and model the strategies in the clinic with parents SESSION 7 – Acknowledging and containing the emotional world of young children: sensitising parents to the emotional reactions of children during traumatic stress and teaching them emotional containment techniques. Nurses' tasks: practise learned techniques in the clinic with parents SESSION 8 – Helping parents deal with children's fears: gaining knowledge about age‐appropriate fears and learn ways to normalise and encourage parents to tolerate and handle them. Nurses' tasks: practise strategies to handle the children's fears in the clinic with parents SESSION 9 – Anger, rage and aggressive behaviour of children: learning the role of aggression and anger in children during traumatic situations and ways to set limits and express anger in a constructive manner. Nurses' tasks: practise ways to deal with anger and behavioural problems with parents SESSION 10 ‐ Building a social shield: acknowledging the importance of social support during traumatic stress and learning ways to assist parents and themselves to seek social support. Nurses' tasks: explore ways to strengthen nurses' peer support as well as enhancing parents' social support SESSION 11 – Preventing secondary traumatisation and burnout: Providing an overview of signs of secondary traumatisation and burnout and exploring the underlying mechanisms. Learning techniques to prevent and decrease these phenomena. Nurses' tasks: practise the learned techniques SESSION 12 ‐ Seeking a better future: reviewing all the skills and techniques that were learned in the programme and planning how to use them further in the future. Nurses will be given an opportunity for closure. Nurses' tasks: establish a stress‐prevention programme for young children and their parents and apply it within the clinic AIMS: provide nurses with psycho‐educational knowledge pertaining to stress and trauma in infants and young children, to provide them with screening tools for identifying children and parents at risk of developing stress‐related problems, equip them with stress management techniques for both children and adults; included knowledge about attachment theory and the development of the child‐parent relationship, the processing of stressful and traumatic experiences, identifying personal strengths and acquiring new coping techniques; nurses learned and practised self‐maintenance tools including skills such as breathing, meditation, relaxation, physical exercises, self‐affirmation and guided imagery; techniques were taught and applied so as to enhance staff team‐building and mutual support compliance: 37 (88.2%) participated in all sessions, 3 (7.1%) participated in 11 sessions, and 2 (4.7%) participated in 10 sessions integrity of delivery: not specified economic information: not specified theoretical basis: designed by the first author in collaboration with the well baby clinic’s chief nurse and the regional supervisors; based on a need assessment performed by the regional supervisors; modules chosen were intended to address the difficulties reported by the well baby clinics' nurses during the war (insufficient personal resources to cope with traumatic conditions, minimal knowledge about stress and trauma in young children, lack of techniques to deal with acutely‐stressed children and their parents); some of the work was based on a resiliency manual for elementary school children developed by the authors (e.g. Berger 2007) Control: wait‐list control (n = 38)
Outcomes	Outcomes collected and reported: professional sense of self‐efficacy ‐ Disaster‐Helper Self‐Efficacy Scale secondary traumatisation, (lack) of compassion satisfaction ‐ ProQOL secondary traumatisation, burnout ‐ ProQOL secondary traumatisation, compassion fatigue ‐ ProQOL self‐esteem ‐ Rosenberg self‐ esteem scale hope ‐ Hope Scale sense of mastery ‐ Mastery Scale Time points measured and reported: 1) pre‐intervention; 2) 3‐month follow‐up (3 months post‐intervention during follow‐up session) Adverse events: not specified
Notes	Contact with authors: no correspondence required Study start/end date: intervention took place between February and May 2007; exact study dates not specified Funding source: funding of the intervention by the ministry of health (no other roles) Declaration of interest: none declared Ethical approval needed/obtained for study: ethical approval by University of Haifa ethics committee Comments by authors: not specified Miscellaneous outcomes by the review authors: not relevant Correspondence: Marc Gelkopf, Lev‐Hasharon Mental Health Center, POB 90000, Netanya 42100, Israel; emgelkopf@013.net.il; Tel.: +972 54 571 4344/9 8981169; fax: +972 9 894 5054: Rony Berger: riberger@netvision.net.il
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "From the 80 who agreed, using a random number generator procedure, 42 WBC nurses received the intervention, while 38 were put on a control condition waiting list (WL)." Quote: "The demographic and exposure data are presented in Table 1. Univariate analyses comparing all the demographic and exposure variables showed no significant differences between the groups." Judgement comment: The investigators describe a random component in the sequence generation process (random‐number generator) and there is verified baseline comparability of groups for demographic and exposure variables.; baseline comparability for outcome variables unclear
Allocation concealment (selection bias)	Unclear risk	Judgement comment: insufficient information about allocation concealment to permit judgement of ‘Low risk’ or ‘High risk’
Blinding of participants and personnel (performance bias) Subjective outcomes	High risk	Judgement comment: blinding of participants and personnel probably not done (face‐to‐face intervention) and the outcome is likely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias) Subjective outcomes	High risk	Judgement comment: insufficient information about blinding of outcome assessment; however, due to potential performance bias (no blinding of participants), the review authors judge that the participants' responses to questionnaires may be affected by the lack of blinding (i.e. knowledge and beliefs about intervention they received)
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Judgement comment: insufficient reporting of attrition/exclusions to permit judgement of ‘Low risk’ or ‘High risk’ (unclear if there were any missing data and if missing data were imputed, for example)
Selective reporting (reporting bias)	Low risk	Judgement comment: no study protocol available, but it is clear that the published report includes all expected outcomes, including those that were prespecified