Dybdahl 2001.
Study characteristics | ||
Methods | Study design: RCT Study grouping: parallel group Study duration: 20 weeks |
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Participants | Inclusion criteria: internally displaced families with children born in 1990 and 1991 (aged 5–6 years) were invited to participate; only those families who were not participating in any other intervention programme and were unlikely to move from the Tuzla region before November 1996 were selected Exclusion criteria: participating in any other intervention programme; likely to move out of the area before November 1996 Age: mothers: mean 30.7 (SD 4.9) years, range 20–44 years; children: mean 5.5 (SD 0.7) years Gender: children: 55% girls, 45% boys Intervention sample: 42 Control sample: 45 Main type of traumatic event: displacement Phase of humanitarian crisis: after the acute crisis (mortality was similar or less than what it was before the crisis). Type of humanitarian crisis: war/armed conflict |
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Interventions | Intervention name: International Child Development Program (ICDP) Delivered by: para‐professionals: group leaders; 5 preschool teachers trained for the study Format of therapy: face to face Number of sessions (total): 20 Type of control: usual care – participants received free basic medical care Type of intervention context: community facility (Psychological Centre in Tuzla) Type of promotion intervention: group level Description of the intervention: the contents and organisation of the psychosocial intervention in this study were based on 2 different sources: 1. therapeutic discussion groups for traumatised women that had been held during the war, and 2. the ICDP. The objectives of the ICDP are to influence the caregiver's positive experience with the child; promote sensitive emotional expressive communication; promote enriching, stimulating interaction; and reactivate indigenous childrearing practices. |
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Outcomes | Mental well‐being
Acceptability (dropout from trial)
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Notes | Sponsorship source: supported, in part, by the United Nations International Children's Emergency Fund (UNICEF) and the University of Tromsø. Country: Bosnia and Herzegovina Setting: 2 areas a few kilometres outside Tuzla (on opposite sides of the town) were chosen, 1 a refugee village or so‐called collective centre, the other an area where displaced people were being accommodated in private homes. Author's name: Ragnhild Dybdahl Institution: University of Tromsø Email: rdybdahl@psyk.uit.no Address: Department of Psychology, University of Tromsø, 9037 Tromsø, Norway |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The assignment was random. All the names of the mother–child dyads were written on pieces of paper, which were folded, mixed together, and then separated into two piles at random so that one pile formed the intervention group and the other pile formed the control group." |
Allocation concealment (selection bias) | Unclear risk | No information provided. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open‐label trial. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The interviewers were experienced mental health workers (e.g., psychiatrists and pedagogues), but were not involved in the treatment of these children. They were blind with respect to which families were in the intervention or control groups, as were the physicians who provided the medical checkups." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition rate intervention group: 16% (7/42 participants dropped out from the study). Attrition rate control group: 11% (5/45 participants dropped out from the study). |
Selective reporting (reporting bias) | Unclear risk | All measures described in the methods section of the article were also reported in the results. No trial protocol/registration number available. |
Therapist qualification | Low risk | 5 preschool teachers were trained as group leaders for the discussion groups. |
Therapist/investigator allegiance | Unclear risk | No information provided. |
Intervention fidelity | Unclear risk | Weekly group meetings with 6–8 group leaders with a supervisor (a mental health professional) (and later twice a month). |
Other bias | Low risk | No other sources of bias detected. |