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. 2024 May 21;2024(5):CD014300. doi: 10.1002/14651858.CD014300.pub2

Leventhal 2015.

Study characteristics
Methods Study design: RCT
Study grouping: parallel group
Study duration: 20 weeks
Participants Inclusion criteria: middle‐school girls attending 1 of 76 government schools in rural Bihar, India
Exclusion criteria: not reported
Age range: 11–14 years
Gender: 100% girls
Intervention sample: 1832
Control sample: 900
Main type of traumatic event: compounded stressors
Phase of humanitarian crisis: during the acute crisis (mortality was still higher than it was before the crisis)
Type of humanitarian crisis: extreme poverty (> 33% of the population lived on < 30 rupees (about 50 cents) per day)
Interventions Intervention name: Girls First Resilience Curriculum
Delivered by: para‐professional
Format of therapy: face to face
Number of sessions (total): 23
Type of control: school as usual (no intervention)
Type of intervention context: school
Type of promotion intervention: group level
Description of the psychosocial intervention: initial sessions integrate methods from positive psychology, social‐emotional learning, and life skills. Girls identified their character strengths and used these to identify and plan to reach goals. Girls then learned coping skills, building on their character strengths and drawing from other positive psychology skills, such as finding benefits in difficult situations ("benefit finding"); and emotional intelligence skills such as identifying and managing difficult emotions. Girls then use these assets as a foundation for problem‐solving and conflict resolution, drawing from restorative practices. In the final sessions, girls worked together to design and carry out projects to increase peace in their own or others' lives. They were asked to exercise character strengths, emotional intelligence, and interpersonal skills, and to use these in a way that was meaningful to them.
Outcomes Mental well‐being
  • Outcome type: continuous outcome

  • Reporting: fully reported

  • Scale: KIDSCREEN‐52 Psychological Wellbeing Subscale

  • Direction: higher is better

  • Data value: change from baseline


Resilience
  • Outcome type: continuous outcome

  • Reporting: fully reported

  • Scale: Connor‐Davidson Resilience Scale‐10

  • Direction: higher is better

  • Data value: change from baseline


Acceptability (dropout from trial)
  • Outcome type: dichotomous outcome

  • Reporting: fully reported

  • Data value: endpoint

Notes Sponsorship source: David & Lucile Packard Foundation
Country: India
Setting: school‐based psychosocial intervention in rural India
Comments: the state of Bihar was chosen for the study as it has 1 of India's poorest populations with > 33% of the population living on < 30 rupees (about 50 cents) per day.
Author's name: Katherine Sachs Leventhal
Institution: CorStone
Email: kates@corstone.org
Address: 250 Camino Alto, Suite 100A, Mill Valley, California 94941, USA
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Stratified block randomization was conducted to distribute schools by location and girl enrolment across Girls First e Bihar conditions (19 schools/condition)."
No further information reported on the method of random sequence generation, but the balance of participant level characteristics suggests that the randomisation procedures were successful.
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 High risk Quote: "Questionnaires were administered at girls' schools by PFs trained to administer assessments and provide help to girls with difficulty reading or understanding questions."
It is unlikely that the PFs were kept blind to intervention allocation.
Incomplete outcome data (attrition bias)
All outcomes Low risk Of the 2508 girls who completed time 1, 121 did not complete time 2 (71 intervention; 50 control).
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 Quote: "the final group of 51 recruited and trained PFs was young (M [mean] = 26.8 years, SD = 6.6 years), with little education (highest level of education completed: 9.8% 10th grade; 47.1% 12th grade; 29.4% Bachelor's degree; 13.7% beyond Bachelor's), and little experience (M = 3.1 years of previous experience, SD = 3.7 years; 39.2% had no prior experience)."
Therapist/investigator allegiance Unclear risk No information provided.
Intervention fidelity Low risk Quote: "Fidelity and quality were measured through MT ratings during session observations. Fidelity ratings consisted of whether PFs followed the RC manual's session structure and content. Ratings indicated that 85.4% of PF pairs followed session structure and 87.2% covered session content adequately or better. Quality ratings indicated that 81.3% of PF pairs presented information clearly, 95.8% managed behavior issues and discipline, 91.7% maintained girls' interest, and 70.8% used facilitative (rather than didactic) methods adequately or better. PFs were given additional training and support during refresher trainings based on these ratings."
Other bias Low risk No other sources of bias can be detected.