Delivering integrated child development care in Pakistan: protocol for a clustered randomised trial

Muhammad Amir Khan; Syeda Somyyah Owais; Claire Blacklock; Shirin Anil; Sehrish Ishaq; Shazia Maqbool; Haroon Jehangir Khan; Fareed A Minhas; John Walley

doi:10.3399/bjgpopen17X100677

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Figure 1. Trial flow diagram

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Box 1. Early child development care in private GP clinics

	Control clinics	Intervention clinics
Mother–child care	Usual care	Standard counselling session on childhood nutrition, development, and maternal mental health, using pictorial flipbook. Monitoring and screening of child growth and maternal mental health. Assessment and treatment (including referral to specialist) of childhood nutrition, development, or maternal depression. Follow-up of mother–child pairs in clinic at 3, 6 and 9 months (including SMS or telephone reminder, if required)
Low dose vitamin A	Yes	Yes
Community advocates	Yes	Yes
Branding of clinic by Directorate General Health Services	Yes	Yes
Training of private doctors (GPs) and clinic assistants	Control clinic staff will receive basic training only, focused on the correct use of study recording forms, with a general overview of the importance of childhood development and maternal health; that is, they will not receive any specific training on intervention activities.	Clinic assistants will be trained by project field coordinator (under supervision of project manager and specialist doctor) using the study clinical assistant training protocol (CATP), which includes: how to conduct a standardised counselling session using the flipbook; how to administer the PHQ-2; and how to measure and record child length and weight. Private GPs will be trained by an experienced specialist according to the study private doctor training protocol (PDTP), which includes: clinical management of children with malnutrition and developmental delay in the private clinic setting; how to use PHQ-9 for the diagnosis of maternal depression; and how to assess the mother–child pair for a specialist referral, when required, to the appropriate public tertiary care facility. The training protocols, both CATP and PDTP, are developed by a group of local experts and specialists, adapted from international best-practice guidelines and standards.^16,17 Training will last approximately 2 hours, and will include a mixture of explanation by the project field coordinator, and role-play exercises by participants.

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Box 2. Logic model for proposed intervention mechanisms/theory of change (adapted from Bonell and colleagues 2015)³⁸

	Inputs	Processes and actions	Intended changes (Theoretical domains framework)²¹	Intended outputs	Intended health outcomes
Intervention	Formative research: interviews with providers, mothers, and key stakeholders Consultation with experts to develop technical materials: • Training protocols and manuals • Counselling flipbook • Community advocate leaflets Training of private GPs and clinic assistants: theoretical and practical training	Quarterly counselling sessions for mothers (child development, child nutrition, maternal mental health) Quarterly child growth monitoring Text message/SMS reminders to mothers for quarterly follow-up appointments Assessment and treatment of chid developmental delay (may include referral) Assessment and treatment of maternal depression (may include)	Mother Social influences Knowledge Beliefs about consequences Environmental context and resources Reinforcement Private GP and clinic assistant Social influences Knowledge Skills Environmental context and resources Social and professional role and identity	Mother Mother–child health services are accessible and desirable to mother Increased capability and confidence to support child nutrition and development in the home environment Increased capability and confidence to protect own mental health in the home environment Private GP and clinic assistant Motivated and skilled to provide mother–child health services	Reduced developmental delay at 12 months of age (primary outcome) Improved childhood nutrition Reduced maternal depression
Both intervention and control arms	DGHS endorsement of intervention and control clinics Identification and orientation of community advocates Growth Monitoring Cards to intervention and control clinics Standard calibrated equipment to intervention and control clinics Supervision of data entry on Growth Monitoring Card by clinic assistant (Field research officer)	Recruitment of mothers by community advocates Vitamin A supplement		Adequate participant recruitment High quality data