Family Networks (FaNs) for Children With Developmental Disorders and Delays

Human Development Research Foundation, Pakistan

Status: Completed

Conditions: Developmental Disabilities; Neurodevelopmental Disorders

Treatments: Behavioral: Family networks program

Study type: Interventional

Funder types: Other

Identifiers

NCT02792894

746-05

Details and patient eligibility

About

Over 6% of children in Pakistan suffer from a developmental disorder (intellectual disability or Autistic spectrum disorder) and most receive no intervention.In an earlier proof of concept study, the investigators integrated social, technological and business innovations to develop and successfully pilot a sustainable service for such children in one rural population of 30,000. Affected families were identified through a mobile phone-based interactive voice response system, and organised into family networks. 'Champion' family volunteers were trained in evidence-based interventions. A Tablet-based android application was developed for training, monitoring and supervision of the champions, based on the World Health Organization's guidelines. The champions delivered the intervention to other families in the network. The project was sustainable and demonstrated significant improvements in the lives of children and their families in the first 6 months of its operation. The investigators are scaling-up this intervention to a population of 1 million. The investigators aim to evaluate the effectiveness and cost effectiveness of the scaled-up programme using cluster randomized control trial nested within the scale-up study.

Enrollment: 540 patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children aged between 2-12 years,
• Screen positive on any of the Ten Questions screen questionnaire items # 1,4,5,7,8,9,10 for developmental disorders and delays.
• Developmental disorder and delay present according to clinical assessment (History & clinical examination for developmental delay in motor, communication, social, cognitive, daily living skills domains according to mhGAP developmental disorders guidelines for clinical assessment

Exclusion criteria

• Co-morbid physical or mental conditions in the child requiring inpatient hospitalization
• Deafness or blindness in the child
• Primary caregiver not available or unwilling to participate in the intervention program for 6 months
• Physical or mental conditions in the primary caregiver needing inpatient hospitalization or frequent outpatient visits (more than two times a month)
• Written consent not obtained for participation in the trial by the primary caregiver

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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540 participants in 2 patient groups

Enhanced Usual Care (EUC)

No Intervention group

Description:

Enhanced Usual Care comprises of normal routine visits conducted by the local community health workers / Lady Health Workers (LHWs). Care is enhanced in 2 ways: (a) LHWs in the EUC arm will receive training in identifying children with developmental disorders and delays, as well as making referrals to their primary care physicians for treatment using the WHO mhGAP training program for developmental disorders and (b) The primary care physicians will receive the training in WHO mental health GAP(mhGAP) program developmental disorders module, by WHO Collaborating Center in Rawalpindi, Pakistan.

Family Networks program

Experimental group

Description:

Intervention is administered once weekly over 9-10 weeks in a group format over 3 hours per sessions. Family networks Program (FaNs) is based on WHO mhGAP module for developmental disorders and incorporates WHO Parent Skills Training program for children with developmental disorders and delays. Parents Skills Training Program includes modules on communication, play, daily living skills, managing challenging behavior, coping with stress. Intervention is provided by the family volunteers (members of community, mostly women, who have a child affected in their families).

Treatment:

Behavioral: Family networks program