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. 2018 Oct 1;2018(9):CD003968. doi: 10.1002/14651858.CD003968.pub5

Daniel 2015.

Study characteristics
Methods RCT. 2 arms. Assessed pretreatment and post‐treatment (6 months)
Participants End of treatment: n = 62
Start of treatment: n = 83
Sex of children: 42 M, 41 F
Mean age of children = 8.48 years (± 2.11)
Source = two comprehensive sickle cell clinics in children’s hospitals
Diagnosis = sickle cell disease
Mean years of illness = lifetime
Interventions "Families Taking Control" (PSST)
"Delayed Intervention Control"
Outcomes Primary pain outcome: none
Primary disability outcome: none
Primary depression outcome: none
Primary anxiety outcome: none

  1. Child measures

    1. Medical chart review to collect genotype and disease complications

    2. Pediatric Quality of Life Inventory

    3. Woodcock Johnson III

    4. Weschler Abbreviated Scale of Intelligence

    5. Social Problem‐Solving Inventory Revised Short Form

    6. Expectancy Form

    7. Expectancy Form

    8. Engagement Rating Form

  2. Parent measures

    1. Hemotology/Oncology Psycho‐Educational Needs Assessment

    2. Pediatric Quality of Life Inventory

    3. Expectancy Form

    4. Expectancy Form

    5. Engagement Rating Form
Notes COI: "Conflicts of interest: None declared."
Funding: "NHLBI (U54 HL070585) to M.S. (PI), BTRP to LPB (PI); and NCMHD (1RC1MD004418) to L.P.B. (PI)."
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "Randomization (stratified by gender in blocks of 10) was concealed from the family and the study team until after completing the baseline assessment when an envelope with randomization status was opened and the family was informed of next steps." Comment: insufficient information about the sequence generation process to permit judgement
Allocation concealment (selection bias) Unclear risk "Randomization (stratified by gender in blocks of 10) was concealed from the family and the study team until after completing the baseline assessment when an envelope with randomization status was opened and the family was informed of next steps." Comment: insufficient information about allocation concealment provided to permit judgement; it was unclear if envelopes were sequentially numbered, opaque, and sealed
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Insufficient information to permit judgement; no statement about whether or not blinding of outcome assessment occurred
Incomplete outcome data (attrition bias)
All outcomes Low risk Attrition was reported, no significant differences between completers and non‐completers were reported
Selective reporting (reporting bias) Low risk Data were fully reported