Kazak 2005.

Methods	Design: pilot RCT
Participants	Setting: oncology service within a children's hospital. Type of trauma exposure: parents of children newly diagnosed with cancer. Inclusion criteria: primary caregivers and partner of children aged 0–17 years newly diagnosed with cancer. Exclusion criteria: single caregivers Sample size: 88 families assessed for eligibility; 19 families (38 individuals were randomised) Median age: 37 year for primary caregivers; 42 years for partners Gender: 18 (47.4%) men; 20 (52.6%) women Ethnicity: not reported. Ethnicity for participants' children: 36.8% African‐American; 52.6% white; 5.3% Asian; 5.3% mixed race Country: USA
Interventions	Group 1: SCCIP‐ND: n = 9 families, n = 18 individuals SCCIP‐ND is an adaptation of an integrated cognitive behavioural and family therapy intervention developed and tested with adolescent survivors of childhood cancer and their families. SCCIP‐ND is intended for 2 caregivers of a child newly diagnosed with cancer. Caregivers work conjointly to identify beliefs about their experiences during the initial month of treatment, a time in which potentially traumatic events may occur. The focus is on understanding how beliefs about cancer and its treatment influence caregivers and to help family members anticipate the impact of cancer on the family over time. Intervention consisted of 3 × 45‐min sessions of a manualised family intervention, SCCIP‐ND. The goal was to deliver the intervention within the first month after the child's cancer diagnosis. Intervention was facilitated by the use of other families who had experienced cancer. The first session focused on identifying beliefs about cancer, its treatment and the impact on the family using the A‐B‐C Model to examine the relationships between perceptions of cancer‐related events and their feelings, actions and relationships. The second session focused on changing beliefs to enhance family functioning. Caregivers learn how to use reframing to modify their beliefs and subsequently, their emotional, behavioural and interpersonal consequences. Participants are then coached to identify new beliefs that accept the uncontrollable; focus on the controllable; acknowledge their own strengths and use the positive session. The third session addressed family growth and the future through the use of 2 metaphors, "The Family Survival Roadmap" and "Putting Cancer in its Place," to help caregivers recognise their beliefs about the family's future, and share these beliefs with each other. Group2: TAU: n = 10 families, n = 20 individuals Usual psychosocial care. Each family was assigned a social worker who attended the initial family meeting, provided resources and supplemental information about the diagnosis and treatment, and offered support.
Outcomes	PTSD: IES‐R Other: STAI Follow‐up: 2 months' post‐treatment
Notes	Participants were randomised by family dyad, rather than individually. All 19 primary caregivers were mothers. Of the partner caregivers, 18 were fathers and 1 was a grandmother.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomisation used a predetermined concealed random assignment list maintained by a staff member unaware of patient identity.
Allocation concealment (selection bias)	Low risk	Randomisation used a predetermined concealed random assignment list maintained by a staff member unaware of patient identity.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Outcome measures were self‐report questionnaires administered by research assistants.
Incomplete outcome data (attrition bias) All outcomes	High risk	The authors did not undertake detailed statistical analysis due to the relatively small sample size. Outcome data were reported only for those available to follow‐up, with a larger number of dropouts (including 4 participants withdrawals) from the intervention group.
Selective reporting (reporting bias)	Unclear risk	No study protocol identified.
Other bias	High risk	Small sample size