Neurodevelopmental DisordersFaNsNCT02792894
Family Networks (FaNs) for Children With Developmental Disorders and Delays
A study testing Family networks program in people with Neurodevelopmental Disorders and Developmental Disabilities, run by Human Development Research Foundation, Pakistan at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Neurodevelopmental Disorders, Developmental Disabilities
- What is being tested?
- Family networks program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 1 sitePakistan
- Study dates
- Apr 2016to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Pakistan1 site
Human Development Research Foundation
Gujar Khan, Punjab Province
About this study
Official title: Evaluation of Family Networks (FaNs) for Children With Developmental Disorders and Delays Program: A Cluster Randomized Control Trial
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.
- Being tested
- Family networks program
- Keywords
- cluster randomized trial, developmental delays, neurodevelopmental disorders, autism, intellectual disability, low resource settings, family volunteers
- Medical subject headings
- Neurodevelopmental Disorders, Developmental Disabilities, Autistic Disorder, Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family networks programBehavioural
Intervention, Family networks Program (FaNs), 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).
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Usual Care (EUC) | No intervention | 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 | 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). Receives: Behavioral: Family networks program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Developmental Disorders- Children Disability Assessment Schedule (DD-CDAS)
The DD-CDAS is a 36-item questionnaire measuring functioning and disability. The 36 items are rated on a five-point Likert scale (1=none to 5=extreme/cannot do). The items represent cognition, mobility, self-care, getting along with others, life activities, and participation in the society. The raw scores are sum across all the items of each domain and all 36 items for a tool. Domain and total raw scores are transformed into a range from 0 to 100. The tool has been validated for children with developmental disorders in Pakistan (DD-CDAS) by our group (Hamdani et al, 2020).
Measured: Change in DD-CDAS score at 6 months post-intervention
Secondary outcomes (7)
Caregiver-Child Interaction
Fifteen minutes video will be recorded to capture caregiver-child interaction. Caregivers will be asked to try home routines involving the child (e.g. feeding the child, performing domestic chores) or play based routines (e.g. playing with toys or reading a book) with their child. Caregiver's facilitators and interrupters (including child's engagement and distress during social communication) and joint engagement will be rated.
Measured: Baseline (Pre treatment) and follow-up (6 months post-intervention)
Strengths and Difficulties Questionnaire (SDQ)
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.
Measured: Baseline (Pre treatment) and follow up (6 months post-intervention)
Family Empowerment Scale (FES)
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.
Measured: Baseline (Pre treatment) and follow up (6 months post-intervention)
Inventory of Stigmatizing Experiences (Family version)
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.
Measured: Baseline (Pre treatment) and follow up (6 months post-intervention)
Pediatric Quality of Life (PedsQL) family impact module
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).
Measured: Baseline (Pre treatment) and follow up (6 months post-intervention)
Client Services Receipt Inventory (CSRI)
Client Services Receipt Inventory has been adapted for use in children and families with developmental disorders.
Measured: Baseline (Pre treatment) and follow up (6 months post-intervention)
Clinical Global Impression (CGI)
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.
Measured: Baseline (Pre treatment) and follow up (6 months post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2017
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Neurodevelopmental DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 540 participants (actual)
Sponsor and investigators
- Lead sponsor
- Human Development Research Foundation, Pakistan
- Sponsor type
- University, hospital or other
- Collaborators
- Grand Challenges Canada, Autism Speaks, World Health Organization, Benazir Bhutto Hospital, Rawalpindi, University of Liverpool
- Responsible party
- Principal investigator, Syed Usman Hamdani, Human Development Research Foundation, Pakistan
- Investigators
- Atif Rahman, PhD, Study director, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02792894
- Sponsor's protocol ID
- 746-05
- Acronym
- FaNs
- Status last verified
- Jan 2021
- First submitted
- 1 Jun 2016
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Hamdani SU, Minhas FA, Iqbal Z, Rahman A. Model for Service Delivery for Developmental Disorders in Low-Income Countries. Pediatrics. 2015 Dec;136(6):1166-72. doi: 10.1542/peds.2015-0861.
PubMed 26598452Hamdani SU, Atif N, Tariq M, Minhas FA, Iqbal Z, Rahman A. Family networks to improve outcomes in children with intellectual and developmental disorders: a qualitative study. Int J Ment Health Syst. 2014 Feb 1;8(1):7. doi: 10.1186/1752-4458-8-7.
PubMed 24485093Hamdani SU, Huma ZE, Wissow L, Rahman A, Gladstone M. Measuring functional disability in children with developmental disorders in low-resource settings: validation of Developmental Disorders-Children Disability Assessment Schedule (DD-CDAS) in rural Pakistan. Glob Ment Health (Camb). 2020 Jul 13;7:e17. doi: 10.1017/gmh.2020.10. eCollection 2020.
PubMed 32913656Hamdani SU, Akhtar P, Zill-E-Huma, Nazir H, Minhas FA, Sikander S, Wang D, Servilli C, Rahman A. WHO Parents Skills Training (PST) programme for children with developmental disorders and delays delivered by Family Volunteers in rural Pakistan: study protocol for effectiveness implementation hybrid cluster randomized controlled trial. Glob Ment Health (Camb). 2017 Jun 13;4:e11. doi: 10.1017/gmh.2017.7. eCollection 2017.
PubMed 29230307Hamdani SU, Huma ZE, Suleman N, Akhtar P, Nazir H, Masood A, Tariq M, Koukab A, Salomone E, Pacione L, Brown F, Shire S, Sikander S, Servili C, Wang D, Minhas FA, Rahman A. Effectiveness of a technology-assisted, family volunteers delivered, brief, multicomponent parents' skills training intervention for children with developmental disorders in rural Pakistan: a cluster randomized controlled trial. Int J Ment Health Syst. 2021 May 31;15(1):53. doi: 10.1186/s13033-021-00476-w.
PubMed 34059074
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Family Networks (FaNs) for Children With Developmental Disorders and Delays Program: A Cluster Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02792894
- Acronym / sponsor ID
- FaNs / 746-05
- Keywords
- cluster randomized trial, developmental delays, neurodevelopmental disorders, autism, intellectual disability, low resource settings, family volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- Human Development Research Foundation, PakistanUniversity, hospital or other
- Collaborators
- Grand Challenges Canada, Autism Speaks, World Health Organization, Benazir Bhutto Hospital, Rawalpindi, University of Liverpool
- Study start
- Apr 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 8 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Usual Care (EUC) | No intervention | –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 | Behavioral: Family networks programIntervention 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). |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family networks programIntervention, Family networks Program (FaNs), 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). | Behavioural | Family Networks program |
Primary outcome
Developmental Disorders- Children Disability Assessment Schedule (DD-CDAS)
Time frame: Change in DD-CDAS score at 6 months post-intervention
The DD-CDAS is a 36-item questionnaire measuring functioning and disability. The 36 items are rated on a five-point Likert scale (1=none to 5=extreme/cannot do). The items represent cognition, mobility, self-care, getting along with others, life activities, and participation in the society. The raw scores are sum across all the items of each domain and all 36 items for a tool. Domain and total raw scores are transformed into a range from 0 to 100. The tool has been validated for children with developmental disorders in Pakistan (DD-CDAS) by our group (Hamdani et al, 2020).
7 secondary outcomes
Caregiver-Child Interaction
Time frame: Baseline (Pre treatment) and follow-up (6 months post-intervention)
Strengths and Difficulties Questionnaire (SDQ)
Time frame: Baseline (Pre treatment) and follow up (6 months post-intervention)
Family Empowerment Scale (FES)
Time frame: Baseline (Pre treatment) and follow up (6 months post-intervention)
Inventory of Stigmatizing Experiences (Family version)
Time frame: Baseline (Pre treatment) and follow up (6 months post-intervention)
Pediatric Quality of Life (PedsQL) family impact module
Time frame: Baseline (Pre treatment) and follow up (6 months post-intervention)
Client Services Receipt Inventory (CSRI)
Time frame: Baseline (Pre treatment) and follow up (6 months post-intervention)
Clinical Global Impression (CGI)
Time frame: Baseline (Pre treatment) and follow up (6 months post-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Background: PubMed 26598452Hamdani SU, Minhas FA, Iqbal Z, Rahman A. Model for Service Delivery for Developmental Disorders in Low-Income Countries. Pediatrics. 2015 Dec;136(6):1166-72. doi: 10.1542/peds.2015-0861.
- Background: PubMed 24485093Hamdani SU, Atif N, Tariq M, Minhas FA, Iqbal Z, Rahman A. Family networks to improve outcomes in children with intellectual and developmental disorders: a qualitative study. Int J Ment Health Syst. 2014 Feb 1;8(1):7. doi: 10.1186/1752-4458-8-7.
- Background: PubMed 32913656Hamdani SU, Huma ZE, Wissow L, Rahman A, Gladstone M. Measuring functional disability in children with developmental disorders in low-resource settings: validation of Developmental Disorders-Children Disability Assessment Schedule (DD-CDAS) in rural Pakistan. Glob Ment Health (Camb). 2020 Jul 13;7:e17. doi: 10.1017/gmh.2020.10. eCollection 2020.
- Background: PubMed 29230307Hamdani SU, Akhtar P, Zill-E-Huma, Nazir H, Minhas FA, Sikander S, Wang D, Servilli C, Rahman A. WHO Parents Skills Training (PST) programme for children with developmental disorders and delays delivered by Family Volunteers in rural Pakistan: study protocol for effectiveness implementation hybrid cluster randomized controlled trial. Glob Ment Health (Camb). 2017 Jun 13;4:e11. doi: 10.1017/gmh.2017.7. eCollection 2017.
- Derived from this study: PubMed 34059074Hamdani SU, Huma ZE, Suleman N, Akhtar P, Nazir H, Masood A, Tariq M, Koukab A, Salomone E, Pacione L, Brown F, Shire S, Sikander S, Servili C, Wang D, Minhas FA, Rahman A. Effectiveness of a technology-assisted, family volunteers delivered, brief, multicomponent parents' skills training intervention for children with developmental disorders in rural Pakistan: a cluster randomized controlled trial. Int J Ment Health Syst. 2021 May 31;15(1):53. doi: 10.1186/s13033-021-00476-w.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Atif Rahman, PhD study director
University of Liverpool
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family networks program in people with Neurodevelopmental Disorders and Developmental Disabilities, run by Human Development Research Foundation, Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Developmental Disorders- Children Disability Assessment Schedule (DD-CDAS) (time frame: Change in DD-CDAS score at 6 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02792894, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.