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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Evaluation of Family Networks (FaNs) for Children With Developmental Disorders and Delays Program: A Cluster Randomized Control Trial

Brief Summary: 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.

Detailed Summary:
Sponsor: Human Development Research Foundation, Pakistan

Current Primary Outcome: WHO Disability Assessment Schedule (children version)(WHODAS-Child) [ Time Frame: Change in WHODAS Child Global Disability Score at 6 months follow up from baseline assessment ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Caregiver-child interaction (CCX) videos [ Time Frame: Baseline (Pre treatment) and follow up (6 months after the baseline) ]
  A 20-25 minutes video will be recorded to capture caregiver-child interaction. Caregivers will be asked to play with the child using a standard toy kit for 12 minutes and to perform a home routine (i.e dressing, eating, book reading etc.). caregiver-child interaction videos will be coded for child outcome including social communication and joint engagement as well as the primary caregiver outcome, care giver's adoption and implementation of intervention strategies.
• Strengths and Difficulties Questionnaire [ Time Frame: Baseline (Pre treatment) and follow up (6 months after the baseline) ]
  Parent rated, 25 items scale. Items are distributed over 5 domains: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior. Each item is rated on a 3-point Likert scale (0 = not true, 1 = somewhat true, 2 = certainly true). Total difficulty score is calculated by adding all the domain scores except prosocial problems.
• Family Empowerment Scale [ Time Frame: Baseline (Pre treatment) and follow up (6 months after the baseline) ]
  Parent rated, 34 items scale, consisting of 3 subscales: The family subscale (12 items) refers to the parents' management of everyday situations. The service system subscale (12 items) refers to parents' acting to obtain services to meet the child's needs. The community subscale (10 items) refers to parents' advocacy for improving services for children in general. Each item is rated on a 5-point Likert scale (1 = not true at all to 5 = very true). Scores are summed across all items for each subscale with higher scores indicating relatively more empowerment.
• Inventory of Stigmatizing Experiences (Family version): [ Time Frame: Baseline (Pre treatment) and follow up (6 months after the baseline) ]
  Interview-based measure of the extent of stigma faced by family. Seven items, each item is rated on a 5-point Likert scale (1 = never to 5 = always). The responses are recoded into a binary variable with 1 reflecting presence of stigma and 0 reflecting absence of stigma. Scores are summed across all items with a maximum score of 7, with lower scores indicating relatively less stigma.
• Pediatric Quality of Life (PedsQL) family impact module [ Time Frame: Baseline (Pre treatment) and follow up (6 months after the baseline) ]
  The 36-item PedsQL™ Family Impact Module Scales encompass 6 sub-scales measuring parent self-reported functioning: 1) Physical Functioning (6 items), 2) Emotional Functioning (5 items), 3) Social Functioning (4 items), 4) Cognitive Functioning (5 items), 5) Communication (3 items), 6) Worry (5 items), and 2 scales measuring parent-reported family functioning; 7) Daily Activities (3 items) and 8) Family Relationships (5 items). Items are rated on a 5 point Likert scale (0 never to 4 almost always). For ease of interpretability, items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better HRQOL (Health-Related Quality of Life).
• Client Services Receipt Inventory [ Time Frame: Baseline (Pre treatment) and follow up (6 months after the baseline) ]
  Client Services Receipt Inventory has been adapted for use in children and families with developmental disorders.
• Clinical global impression [ Time Frame: Baseline (Pre treatment) and follow up (6 months after the baseline) ]
  Clinical global impression (CGI) measures severity of challenges in social communication (rated from 1-7) (b) improvement in social communication at 6 months follow up (rated from 1-7). The CGI will be rated from the CCX videotapes by observers blinded to intervention allocation.

Original Secondary Outcome: Same as current

Information By: Human Development Research Foundation, Pakistan

Dates:
Date Received: June 1, 2016
Date Started: April 2016
Date Completion: April 2018
Last Updated: February 23, 2017
Last Verified: February 2017