Translation, adaptation, and pilot of a guided self-help intervention to reduce psychological distress in South Sudanese refugees in Uganda

Probably not a substantial claim: may not pass S3 (load-bearing).

Facilitator training and supervision led to further suggested changes to delivery methods.

“Facilitator training and supervision led to further suggested changes to delivery methods.”

Classified as probably not a substantial claim. May combine two claims.

The process evaluation resulted in further adaptations to intervention materials and the decision to focus future effectiveness evaluations of the intervention in its current form on South Sudanese female refugees.

“The process evaluation resulted in further adaptations to intervention materials and the decision to focus future effectiveness evaluations of the intervention in its current form on South Sudanese female refugees.”

May combine two claims.

Psychological flexibility was negatively correlated with psychological distress, functional impairment, and depression, and positively correlated with wellbeing, such that higher psychological flexibility was related to better outcomes, as expected.

“Similarly, psychological flexibility was negatively correlated with psychological distress, functional impairment, and depression, and positively correlated with wellbeing, such that higher psychological flexibility was related to better outcomes, as expected.”

May combine two claims.

The group did not suggest any changes to the audio script and only proposed three changes to images.

“The group did not suggest any changes to the audio script and only proposed three changes to images.”

May combine two claims.

Participants indicated that the skills taught by the program helped reduce ethnic tensions and increased socially supportive behaviors.

“Participants also indicated that the skills taught by the program helped reduce ethnic tensions and increased socially supportive behaviors.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

During and after supervision, facilitators provided additional suggestions for changes separate to the process evaluation including removal of worksheets, simplifying the audio script, reducing the length of sessions and some exercises, adding audio cues, and showing relevant illustrations.

“During and after supervision, facilitators provided additional suggestions for changes separate to the process evaluation including, removal of worksheets (due to literacy concerns), simplifying the audio script, reducing the length of sessions and some exercises, adding audio cues to signal when a facilitator had to do an activity, and showing relevant illustrations from the SH+ manual to support”

May combine two claims.

Attendance in the male group was mixed: 38% of men (n = 12) missed none or one (out of five) sessions, 31% (n = 10) missed two or three sessions, and 31% (n = 10) missed four sessions.

“Attendance in the male group was mixed: 38% of men (n = 12) missed none or one (out of five) sessions, 31% (n = 10) missed two or three sessions, and 31% (n = 10) missed four sessions.”

May combine two claims.

Internal consistency estimates were as follows: K6 α = 0.55; WHODAS 2.0 α = 0.69; PHQ-9 α = 0.75; WHO-5 α = 0.77; AAQ-II α = 0.76.

“Internal consistency estimates were as follows: K6 α = 0.55; WHODAS 2.0 α = 0.69; PHQ-9 α = 0.75; WHO-5 α = 0.77; AAQ-II α = 0.76.”

May combine two claims.

Participants frequently re-iterated that the intervention was seen as helpful, but were not always able to explain specifically how.

“Participants frequently re-iterated that the intervention was seen as helpful, but were not always able to explain specifically how.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Health workers proposed 31 changes to the illustrated manual and 42 to the audio script.

“Health workers proposed 31 changes to the illustrated manual and 42 to the audio script.”

Probably not a substantial claim: may not pass S3 (load-bearing).

These changes were incorporated after the pilot.

“These changes were incorporated after the pilot.”

May combine two claims.

All correlations between outcome measures were in the expected directions, although they did not always reach statistical significance in this small sample.

“All correlations were in the expected directions, although they did not always reach statistical significance in this small sample.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The group of lay people consisted of 12 South Sudanese refugees of both sexes and various ages.

“The group of lay people consisted of 12 South Sudanese refugees of both sexes and various ages.”

May combine two claims.

Pre- to post-assessment changes were in the expected direction on all measures and reached statistical significance despite the low sample size.

“Pre- to post-assessment changes were in the expected direction on all measures and reached statistical significance despite the low sample size.”

May combine two claims.

Sub-themes on overall helpfulness, appropriateness, involvement of family and friends, and proposed adaptations were described by all participants, though in more depth by completers.

“Sub-themes on the overall helpfulness of the program, appropriateness, involvement of family and friends, and proposed adaptations were described by all participants, though in more depth by completers.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Further changes were identified during the regular supervision.

“Further changes were identified during the regular supervision.”

May combine two claims.

Attendance in the female group was high: 76% of women (n = 25) missed none or one (out of five) sessions, and 25% (n = 8) missed two or three sessions.

“Attendance in the female group was high: 76% of women (n = 25) missed none or one (out of five) sessions, and 25% (n = 8) missed two or three sessions.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Changes to SH+ were identified during the training, recorded in field notes and later categorized using the Bernal et al. (1995) framework.

“Changes to SH+ were identified during the training, recorded in field notes and later categorized using the Bernal et al. (1995) framework.”

• cites Bernal et al., 1995Not checked yet

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May combine two claims.

All facilitators suggested that for participants the minimal facilitator role would be unusual and different from previous experiences, so the facilitator role was adapted to somewhat increase their presence in the process.

“All facilitators suggested that for participants this would be unusual and different from previous experiences, so the facilitator role was adapted to somewhat increase their presence in the process by starting the group, introducing the audio, and giving increased (but still minimal) clarifications and instructions to participants.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The theme of attendance was discussed primarily in interviews with participants who dropped out part way through the program.

“The theme of attendance was discussed primarily in interviews with participants who dropped out part way through the program.”

May combine two claims.

During training, facilitators suggested changes primarily to the delivery method of SH+, including providing a longer spoken introduction, using energizer games or an opening activity consistent with practice in Rhino camp, setting ground rules as a group, and providing further explanations of key concepts where required.

“During training, facilitators suggested changes primarily to the delivery method of SH+, including providing a longer spoken introduction, using energizer games or an opening activity consistent with practice in Rhino camp (e.g., singing and dancing), setting ground rules as a group, and providing further explanations of key concepts where required.”

May combine two claims.

Even participants unable to read Juba Arabic indicated they understood the meaning from the illustrations in the manual and enjoyed looking at the illustrations, particularly after attending SH+ sessions.

“Even those who were unable to read Juba Arabic indicated that they understood the meaning from the illustrations in the manual and enjoyed looking at the illustrations, particularly after attending the SH+ sessions.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Supervision Skype calls from Geneva occurred less than once a week and were less than 1 hour in length.

“As a result, supervision Skype calls from Geneva occurred less than once a week and was less than 1 hour in length.”

May combine two claims.

A total of 86 men and women were screened for participation and 65 (76%) (33 women, 32 men) who scored above 5 on the K6 were included in the study.

“A total of 86 men and women were screened for participation and 65 (76%) (33 women, 32 men) who scored above 5 on the K6 were included in the study (Table 1).”

Probably not a substantial claim: may not pass S3 (load-bearing).

Group cognitive interviews were carried out with one group of health workers and one group of laypersons.

“Group cognitive interviews were carried out with one group of health workers and one group of laypersons.”

May combine two claims.

The lack of provision of basic goods or services as part of SH+ delivery was one of the primary challenges mentioned by all participants, although the extent to which it was a barrier to attendance varied.

“The fact that no basic goods or services were provided as part of SH+ delivery was one of the primary challenges that were mentioned by all participants, although the extent to which this was a barrier to attendance varied.”

May combine two claims.

Participants emphasized the relevance of many of the SH+ concepts to their community due to the stresses that they were facing and did not indicate that any of the text or illustrations were offensive.

“Participants emphasized the relevance of many of the SH+ concepts to their community due to the stresses that they were facing and did not indicate that any of the text or illustrations were offensive.”

May combine two claims.

A number of participants reported focusing their problem-solving on things that could be changed, as well as improvements in awareness, sleep, and ability to enjoy daily activities.

“A number of participants also reported focusing their problem-solving on things that could be changed, as well as improvements in their awareness, sleep, and the ability to enjoy daily activities.”

Probably not a substantial claim: may not pass S3 (load-bearing).

During training, facilitators reported some content (e.g. a repeated grounding exercise) was too long.

“During training, facilitators reported some content (e.g. a repeated grounding exercise) was too long (though these changes could not be incorporated before the Phase 3 pilot).”

May combine two claims.

Participants indicated they could easily understand and relate to the illustrations, and several indicated they had shared the illustrated manual with others in their community.

“These participants indicated that they could easily understand and relate to the illustrations and several indicated that they had shared the illustrated manual with others in their community.”

May combine two claims.

Overall, participants indicated that each of the sections in the materials covered during cognitive interviewing were comprehensible, relevant, and acceptable.

“Overall, participants indicated that each of the sections in the materials covered during cognitive interviewing were comprehensible, relevant, and acceptable.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Non-partner sexual violence was reported by two women (6%) and two men (6%).

“Non-partner violence was reported by 11 women (33%) and nine men (28%) (physical violence) and two women (6%) and two men (6%) (sexual violence).”

Probably not a substantial claim: may not pass S3 (load-bearing).

We were unable to conduct post-intervention interviews with 11 participants [17%: three female (9%), eight male (25%)].

“We were unable to conduct post-intervention interviews with 11 participants [17%: three female (9%), eight male (25%)].”

May combine two claims.

Participants on average reported severe mental distress at baseline (M = 14.5, s.d. = 4.1), as compared with the commonly used cut-off score of 13 for severe psychological distress on the K6.

“Participants on average reported severe mental distress at baseline (M = 14.5, s.d. = 4.1), as compared with the commonly used cut-off score of 13 for severe psychological distress on the K6.”

May combine two claims.

Internal consistency estimates (Cronbach's Alpha) were satisfactory for all measures except for the K6, ranging from α = 0.55 to 0.77.

“Internal consistency estimates (Cronbach's Alpha) were satisfactory for all measures except for the K6, ranging from α = 0.55 to 0.77.”

May combine two claims.

Psychometric properties of measures overall were satisfactory in terms of internal consistency, sensitivity to change, and convergent/discriminant validity.

“Psychometric properties of measures overall were satisfactory in terms of internal consistency, sensitivity to change, and convergent/ discriminant validity.”

May combine two claims.

Some male participants did not engage with the program, indicating that some other men were talking during the intervention and some men drank alcohol before attending sessions.

“Finally, some male participants did not engage with the program indicating that some other men were talking when the intervention was ongoing and that there were men drinking alcohol before attending sessions”

Probably not a substantial claim: may not pass S3 (load-bearing).

Some key informants indicated they would be more comfortable listening to a recording in their ethnic language.

“Others indicated that they would be more comfortable listening to a recording in their ethnic language.”

May combine two claims.

Participants indicated that some younger male participants, in particular, did not find the program interesting and were not open to learning in that setting.

“Participants indicated that some younger male participants, in particular, did not find the program interesting and were not open to learning in that setting.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Numerous minor changes to language and images were suggested during the cognitive interviewing.

“Numerous minor changes to language and images were suggested during the cognitive interviewing”

May combine two claims.

The group cognitive interviews with laypersons did not lead to substantial suggestions for adaptations, in contrast to more detailed suggestions from health workers and process evaluation participants.

“First, the group cognitive interviews with laypersons did not lead to substantial suggestions for adaptations, in contrast to the more detailed suggestions from group cognitive interviews with health workers, as well as the comments from intervention participants in the process evaluation.”

May combine two claims.

Some participants indicated attending every session was challenging given many other activities in the camp, and one SH+ session coincided with a food distribution activity scheduled by another agency.

“Others indicated that attending every session was challenging given the many other activities ongoing in the camp. For instance, one of the SH+ sessions coincided with a food distribution activity that had been scheduled by another agency working in the camp making it challenging for participants to attend that day.”

May combine two claims.

The guided self-help intervention could be adapted for and feasibly implemented among female South Sudanese refugees in northern Uganda.

“We found that this potentially scalable, guided self-help intervention could be adapted for and feasibly implemented among female South Sudanese refugees in northern Uganda.”

• AssumptionRests on an assumption: The pilot sample and setting are representative of female South Sudanese refugees in northern Uganda, so that feasibility findings generalize.

May combine two claims.

Although there is evidence from randomized controlled trials supporting psychotherapies for PTSD, such interventions have limitations with regard to their feasibility for scale-up in disrupted and under-resourced health systems, given the need for an extensive workforce of adequately trained providers and supervisors.

“Second, although there is evidence from randomized controlled trials supporting psychotherapies (e.g., for PTSD, trauma-focused cognitive behavioral therapies and eye movement desensitization and reprocessing) (Tol et al., 2013a) such interventions have limitations with regard to their feasibility for scale-up in disrupted and under-resourced health systems, given the need for an extensive workfor”

• cites Tol et al., 2013aNot checked yet

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• cites Tol et al., 2014Not checked yet

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• cites Silove et al., 2017Not checked yet

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Probably not a substantial claim: may not pass S3 (load-bearing).

A recent systematic review and epidemiological modeling study with conflict-affected populations in non-Western settings found age-standardized pooled prevalence rates of 12.9% for PTSD (66 studies, 27 countries) and 7.6% for depression (33 studies, 20 countries).

“A recent systematic review and epidemiological modeling study with conflict-affected populations in non-Western settings found age-standardized pooled prevalence rates of 12.9% for post-traumatic stress disorder (PTSD) (66 studies, 27 countries) and 7.6% for depression (33 studies, 20 countries) (Charlson et al., 2016).”

• cites Charlson et al., 2016Not checked yet

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Probably not a substantial claim: may not pass S3 (load-bearing).

Adaptation frameworks commonly suggest iterative processes that emphasize engaging with stakeholders through qualitative research approaches before piloting the intervention using process evaluation methods.

“Adaptation frameworks commonly suggest iterative processes that emphasize engaging with stakeholders through qualitative research approaches before piloting the intervention using process evaluation methods. Adapted interventions may then be tested using controlled designs (Medical Research Council, 2008; Chowdhary et al., 2014).”

• cites Medical Research Council, 2008Not checked yet

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• cites Chowdhary et al., 2014Not checked yet

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May combine two claims.

WHO has developed a stress management package based on a guided self-help format called Self-Help Plus (SH+) that may address the aforementioned barriers.

“As part of efforts to make available a series of scalable psychological interventions, the World Health Organization (WHO) has developed a stress management package based on a guided self-help format called Self-Help Plus (SH+) that may address aforementioned barriers (Epping-Jordan et al., 2016).”

• cites Epping-Jordan et al., 2016Not checked yet

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Probably not a substantial claim: may not pass S3 (load-bearing).

Intervention research in LMIC humanitarian settings has often focused on evaluating psychotherapeutic interventions for PTSD and depression.

“In keeping with this epidemiological literature, intervention research in LMIC humanitarian settings has often focused on evaluating psychotherapeutic interventions for PTSD and depression (Tol et al., 2011).”

• cites Tol et al., 2011Not checked yet

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Classified as probably not a substantial claim.

Several frameworks for the cultural adaptation of psychological interventions have been published.

“Several frameworks for the cultural adaptation of psychological interventions have been published (Bernal et al., 1995; Hwang, 2009; Barrera et al., 2013) with adapted interventions appearing to be more effective than non-adapted interventions (Benish et al., 2011; Harper Shehadeh et al., 2016).”

• cites Bernal et al., 1995Not checked yet

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• cites Hwang, 2009Not checked yet

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• cites Barrera et al., 2013Not checked yet

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Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Study procedures were approved by the WHO Ethics Review Committee, Johns Hopkins Bloomberg School of Public Health Institutional Review Board, the Lacor Hospital Institutional Research and Ethics Committee, and the Uganda National Council for Science and Technology.

“Study procedures were approved by the WHO Ethics Review Committee, Johns Hopkins Bloomberg School of Public Health Institutional Review Board, the Lacor Hospital Institutional Research and Ethics Committee, and the Uganda National Council for Science and Technology.”

Classified as probably not a substantial claim.

WHO is in the process of developing a systematic psychological intervention adaptation framework, inspired, in part, by earlier work on translation and adaptation of instruments.

“WHO is in the process of developing a systematic psychological intervention adaptation framework, inspired, in part, by earlier work on translation and adaptation of instruments (van Ommeren et al., 1999).”

• cites van Ommeren et al., 1999Not checked yet

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Probably not a substantial claim: may not pass S3 (load-bearing).

All groups were successfully conducted by the facilitator team.

“All groups were successfully conducted by the facilitator team.”

Classified as probably not a substantial claim. May combine two claims.

Based on the premise that attempts to suppress or avoid unwanted thoughts and feelings may paradoxically worsen them, ACT teaches alternative methods to accommodate difficult thoughts and feelings, primarily through mindfulness techniques.

“Based on the premise that attempts to suppress or avoid unwanted thoughts and feelings may paradoxically worsen them, ACT teaches alternative methods to accommodate difficult thoughts and feelings, primarily through mindfulness techniques. At the same time, ACT also focuses on guiding participants to live in ways consistent with their personal values (Hayes et al., 2011).”

• cites Hayes et al., 2011Not checked yet

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May combine two claims.

Translation into one of the ethnic languages would limit accessibility for other ethnic groups, and may have been perceived as privileging one ethnic group over another.

“Translation into one of these languages would limit accessibility for other ethnic groups, and may have been perceived as privileging one ethnic group over another.”

Classified as probably not a substantial claim. May combine two claims.

SH+ is intended to decrease psychological distress in people with or without a diagnosed condition associated with a range of adversities, but is not intended for participants with severe health problems such as psychosis or imminent risk of suicide.

“SH+ is intended to decrease psychological distress in people with or without a diagnosed condition associated with a range of adversities (e.g., interpersonal and collective violence, chronic poverty), but is not intended for participants with severe health problems such as psychosis or imminent risk of suicide (Epping-Jordan et al., 2016).”

• cites Epping-Jordan et al., 2016Not checked yet

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Probably not a substantial claim: may not pass S4 (based).

The current study is the first effort to apply key aspects of this framework and adapt a self-help intervention with refugees in a LMIC.

“The current study is the first effort to apply key aspects of this framework and adapt a self-help intervention with refugees in a LMIC.”

May combine two claims.

The intervention is based on principles of Acceptance and Commitment Therapy (ACT), a third-wave cognitive behavioral therapy that aims to enhance psychological flexibility.

“The intervention is based on principles of Acceptance and Commitment Therapy (ACT), a third-wave cognitive behavioral therapy that aims to enhance psychological flexibility (Hayes et al., 2006).”

• cites Hayes et al., 2006Not checked yet

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Probably not a substantial claim: may not pass S3 (load-bearing).

ACT also focuses on guiding participants to live in ways consistent with their personal values.

“Based on the premise that attempts to suppress or avoid unwanted thoughts and feelings may paradoxically worsen them, ACT teaches alternative methods to accommodate difficult thoughts and feelings, primarily through mindfulness techniques. At the same time, ACT also focuses on guiding participants to live in ways consistent with their personal values (Hayes et al., 2011).”

• cites Hayes et al., 2011Not checked yet

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Probably not a substantial claim: may not pass S3 (load-bearing).

All participants signed informed consent forms or noted consent with a thumbprint.

“All participants signed informed consent forms or noted consent with a thumbprint.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Typically, researchers have taken a 'middle ground' approach in which adaptations are made to enhance acceptability and effectiveness while maintaining fidelity to the core elements of the psychological intervention.

“Typically, researchers have taken a ‘middle ground’ approach in which adaptations are made to enhance acceptability and effectiveness while maintaining fidelity to the core elements of the psychological intervention (Chowdhary et al., 2014).”

• cites Chowdhary et al., 2014Not checked yet

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Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Cognitive interviewing is commonly used to check whether the meaning of survey questions has been translated accurately, but has also been applied in the development of interventions such as health education materials.

“Cognitive interviewing is commonly used to check whether the meaning of survey questions has been translated accurately (Beatty & Willis, 2007), but has also been applied in the development of interventions such as health education materials (Carbone et al., 2002).”

• cites Beatty & Willis, 2007Not checked yet

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• cites Carbone et al., 2002Not checked yet

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Probably not a substantial claim: may not pass S2 (checkable).

The format of the intervention, including large group and relatively light training and supervision requirements, would allow for easier integration as compared with other psychotherapeutic interventions.

“This may be a particularly interesting avenue because the format of the intervention (e.g. large group, relatively light training and supervision requirements) would allow for easier integration as compared with other psychotherapeutic interventions.”

Probably not a substantial claim: may not pass S2 (checkable). May combine two claims.

The study findings highlight the importance of taking an iterative and comprehensive approach to adaptation that uses multiple methods drawing from diverse fields and views adaptation as a continuous process of improvement.

“Overall, we feel the study findings highlight the importance, particularly with new or innovatively delivered interventions, of taking an iterative and comprehensive approach to adaptation that uses multiple methods drawing from diverse fields and views adaptation as a continuous process of improvement.”

Probably not a substantial claim: may not pass S2 (checkable).

The iterative and comprehensive adaptation approach resulted in a more feasible and easy to deliver intervention than would have been the case if adaptation was viewed as a singular event occurring before piloting.

“Our experience of this approach has been that it resulted in a more feasible and easy to deliver intervention than would have been the case if the adaptation was viewed as a singular event occurring before piloting.”

Probably not a substantial claim: may not pass S3 (load-bearing).

A systematic review of adaptation efforts of depression interventions found that the most common adaptations are in language, therapist, contextual fit, and methods.

“A systematic review of adaptation efforts of depression interventions found that the most common adaptations are in the categories of language (e.g. use of colloquial expressions); therapist (e.g. adjusting therapeutic style); contextual fit (e.g., inclusion of family members if requested); and methods (e.g. reducing tasks relying on literacy) (Chowdhary et al., 2014).”

• cites Chowdhary et al., 2014Not checked yet

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Probably not a substantial claim: may not pass S2 (checkable). May combine two claims.

If proven effective, SH+ could be more feasibly integrated into other humanitarian programs, which may assist in breaking observed vicious cycles between social determinants and psychological distress.

“If proven effective, SH+ could be more feasibly integrated into other humanitarian programs, which may assist in breaking observed vicious cycles between social determinants (e.g., poverty and intimate partner violence) and psychological distress (Lund et al., 2011; Tol et al., 2017).”

• cites Lund et al., 2011Not checked yet

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• cites Tol et al., 2017Not checked yet

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May combine two claims.

Low attendance of men, negative dynamics due to alcohol use by some participants, and observed disinterest of young men indicated a need for further intervention development with this population.

“We felt the low attendance of men, negative dynamics due to alcohol use by some participants, and observed disinterest of young men in particular, indicated the need for further intervention development with this population.”

Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing).

The research contributes to a wider consideration of opportunities and challenges associated with the global dissemination of psychological interventions.

“As such, the research contributes to a wider consideration of opportunities and challenges associated with the global dissemination of psychological interventions (Fairburn & Patel, 2014; White et al., 2017).”

• cites Fairburn & Patel, 2014Not checked yet

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• cites White et al., 2017Not checked yet

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Classified as probably not a substantial claim. May combine two claims.

Training and pilot implementation identified a need to increase the role of facilitators, including introducing sessions, providing instructions for group discussions instead of using audio, and answering questions to clarify content.

“a need to increase the role of facilitators (e.g. by introducing sessions, providing the instructions for group discussions instead of using the audio to do so, and answering questions to clarify content)”

May combine two claims.

The pilot study's assessment of pre- and post-intervention scores was completed with a small convenience sample without a control group, and did not take into account participants lost to follow-up (17%: three women, eight men).

“Second, the pilot study's assessment of pre- and post-intervention scores was completed with a small convenience sample without a control group, and did not take into account participants lost to follow-up (17%: three women, eight men).”

May combine two claims.

The analysis of the qualitative process evaluation data was conducted by one person, increasing the risk for subjectivity in analyses.

“Third, the analysis of the qualitative process evaluation data was conducted by one person, increasing the risk for subjectivity in analyses.”

May combine two claims.

The revised approach retained the advantages of using audio-recorded materials and an illustrated manual over conventional group psychotherapeutic interventions, including easier fidelity, larger groups, and reduced training and supervision requirements.

“This approach retained the advantages of using audio-recorded materials and an illustrated manual over conventional group psychotherapeutic interventions (i.e. easier to ensure fidelity to intervention content, ability to have larger groups, reduced training, and supervision requirements).”

Classified as probably not a substantial claim. May combine two claims.

The pre-post results should not be interpreted as an indication of the effectiveness of the intervention but rather as an indication of the potential appropriateness of the assessment measures and trends for future controlled studies.

“These results should not be interpreted as an indication of the effectiveness of the intervention but rather as an indication of the potential appropriateness of the assessment measures and trends that should be explored further in future controlled studies.”