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

Levy 2017.

Study characteristics
Methods RCT. 3 arms (only 2 arms included here, see Interventions below). Assessed at pretreatment, 1 week, 3 months, and 6 months after treatment.
Participants End of treatment: n = 166 children; 170 parents.
3 month follow‐up: n = 160 children; 164 parents.
6 months follow‐up: n = 159 children; 164 parents.
Start of treatment: n = 216
Child Sex: 140 F, 76 M; Parent Sex: 205 F, 11 M
Child mean age = 9.4 years (SD = 1.7); parent mean age = 39.8 years (7.7)
Source = paediatric GI clinics
Diagnosis = functional abdominal pain
Mean years of pain = not reported
Interventions "Social learning cognitive‐behavioral therapy (face‐to‐face)"
"Social learning cognitive‐behavioral therapy‐Remote (delivered via the telephone)" ‐ this condition was excluded from this review. See Fisher 2015 for remotely‐delivered psychological interventions.
"Education support"
Outcomes Primary pain outcome: Abdominal Pain Index‐ Severity
Primary disability outcome: Functional Disability Inventory (parent report)
Primary depression outcome: None
Primary anxiety outcome: Pain Response Inventory ‐ Catastrophizing subscale

  1. Child reported measures

    1. Abdominal Pain Index (child report)

    2. Pain Response Inventory

    3. Children's Somatization Inventory

    4. Pediatric Quality of Life Inventory

  2. Parent reported measures

    1. Adults' Responses to Children's Symptoms

    2. Pain Beliefs Questionnaire

    3. Pain Catastrophizing Scale for Parents

    4. Functional Disability Inventory

    5. Healthcare utilisation

    6. School attendance

    7. Pain Behavior Child Lise (parent report)

    8. Children's Somatization Inventory

    9. Pediatric Quality of Life Inventory
Notes COI: "The authors have no conflicts of interest relevant to this article to disclose."
Funding: "This study was supported by award R01HD36069‐0981 from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (R.L.L.)."
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Randomization using a computer‐generated randomization sequence occurred after baseline assessments, stratified by child gender and baseline parent‐reported child pain severity scores on the Abdominal Pain Index (API) (scores at or above 1.75 [the median value from our previous study] vs below)"
Comment: probably done
Allocation concealment (selection bias) Unclear risk "After enrolment and completion of baseline assessments, the study coordinator queried the randomization database for treatment assignment and then scheduled sessions with the
participant."
Comment: unclear allocation concealment
Blinding of outcome assessment (detection bias)
All outcomes Low risk "Parents completed questionnaires online or by mail (90.5% online). Children completed assessments through a telephone call with a trained interviewer blinded to study hypotheses and treatment assignment."
Comment: probably done
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Data attrition fully reported. Differences between completers and non‐completers of the study
Selective reporting (reporting bias) Low risk All data was reported