Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000360314
Ethics application status
Approved
Date submitted
3/03/2017
Date registered
8/03/2017
Date last updated
2/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Parenting program versus telephone support for Mexican parents of children with acquired brain injury: a blind randomized controlled trial.
Scientific title
- Signposts for Building Better Behavior- a parenting program to prevent difficult behavior in children with acquired brain injury: Feasibility and efficacy with a Mexican population
Secondary ID [1] 291332 0
None
Universal Trial Number (UTN)
U1111-1193-6891
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired brain injury 302311 0
Condition category
Condition code
Mental Health 301897 301897 0 0
Other mental health disorders
Neurological 301961 301961 0 0
Other neurological disorders
Injuries and Accidents 301962 301962 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Signposts for building better behavior (Signposts). The Spanish version includes a workbook translated to Spanish with permission from the Parenting Research Centre, Victoria, Australia, and the module "Dealing with a Head Injury in the Family” translated with permission of Damith Woods. Two Signpost’s certified practitioners reviewed the translation to assure that the content was accurate. The parents are able to take notes during the sessions and a sheet listing the key concepts of the session is provided. The provider is a clinical neuropsychologist and a certified Signposts practitioner. The content per session is the following: Introduction, dealing with a head injury in the family and measuring your child behavior (Session 1); Systematic use of daily interactions (Session 2); Replacing difficult behavior with useful behavior (Session 3); Planning for better behavior (Session 4); Teaching your child new skills (Session 5); Dealing with stress and your family as a team (Session 6). Signposts is a manualized parenting program that aims to develop skills in parents to improve behavior. Signposts promotes parental self-regulation because the parent chooses the goals, measures and monitors the child behaviors, chooses the strategies and evaluates the effectiveness. This parenting program is delivered in 6 face to face weekly sessions of 2.5 hours each. The sessions are delivered in groups of a maximum of 8 parents. The intervention is conducted at Iskalti-Condesa, one of the clinics of Iskalti Centre of Psychological and Educational Support. This clinic is close to the center of Mexico City and is well equipped to conduct neuropsychological assessments and provide the intervention program. To improve intervention adherence a checklist with the topics of each session is included and filled by the certified practitioner who delivers the program.
Intervention code [1] 297360 0
Behaviour
Intervention code [2] 297362 0
Rehabilitation
Comparator / control treatment
The participants in the control group receive an information sheet specifically designed for this study with strategies for challenging behaviors and weekly phone calls during 6 weeks done by a psychologist. The phone calls are designed for the parents and aim to imrpove academic skills of the child. Each phone call lasts approximately 15 minutes. During the phone calls exercises which aim to improve academic skills, such as math’s or reading are suggested. The academic skill is chosen based on the area of main concern of the parent.
Control group
Active

Outcomes
Primary outcome [1] 301331 0
Child behavior at home assessed with Eyberg Child Behavior Inventory (ECBI, Eyberg & Pincus, 1999) and the Child Behavior Checklist parent form (CBCL:Achenbach et al., 2001).
Timepoint [1] 301331 0
Baseline, and immediately after the intervention and three months once the intervention was concluded.
Primary outcome [2] 301332 0
Parenting practices assessed with the The Parenting Scale (Arnold, 1993).
Timepoint [2] 301332 0
Baseline, and immediately after the intervention and three months once the intervention was concluded.
Primary outcome [3] 301333 0
Parent stress assessed with the Parent Stress Index short form (Abidin, 2012).
Timepoint [3] 301333 0
Baseline, and immediately after the intervention and three months once the intervention was concluded.
Secondary outcome [1] 332339 0
Child behavior at school as assessed with the Sutter-Eyberg Student Behavior Inventory-Revised (SESBI, Eyberg & Pincus, 1999) and the Teacher Report Form (TRF, Achenbach & Resco, 2001).
Timepoint [1] 332339 0
Baseline, and immediately after the intervention and three months once the intervention was completed.
Secondary outcome [2] 332340 0
Child´s cognitive self-regulation as assessed with the Metacognition Index score from the Behavior Rating Inventory of Executive Function parent form (Gioia, lsquith, Guy, & Kenworthy, 2000), the Test of Everyday Attention for Children Second Edition (Manly et al., 2016) scores from the: Balloon-hunt and the Hide and seek (5-8 years) or Hector cancellation and Hecuba visual search (> 8 years) and Matching Familiar Figure Test (Buela-Casal, Carretero-Dios, & Santos-Roig, 2005).
Timepoint [2] 332340 0
Baseline, immediately after the intervention and three months once the intervention was completed.
Secondary outcome [3] 332341 0
Child´s emotional self-regulation as assesed with the Emotional control subscale from the Behavior Rating Inventory of Executive Function parent form (Gioia, lsquith, Guy, & Kenworthy, 2000) and the Emotion Regulation Checklist. (Shields & Cicchetti, 1997).
Timepoint [3] 332341 0
Baseline, immediately after the intervention and three months once the intervention was completed.
Secondary outcome [4] 332342 0
Child´s behavior self-regulation as assessed with the Behavior Regulation Index from the Behavior Rating Inventory of Executive Function parent form (Gioia, lsquith, Guy, & Kenworthy, 2000) and 10-minute Delay Gratification Task (Mischel, 1972).
Timepoint [4] 332342 0
Baseline, immediately after the intervention and three months once the intervention was completed.
Secondary outcome [5] 332343 0
Parent self-efficacy as assessed by the parent sense of competence scale (Menéndez, Jiménez, & Hidalgo, 2011).
Timepoint [5] 332343 0
Baseline, immediately after the intervention and three months once the intervention was completed.
Secondary outcome [6] 332344 0
Feasibility as assessed with the the percentage of sessions attended or phone calls answered and the total score of the Abbreviated Acceptability Rating Profile-Parenting (Tarnowski & Simonian, 1992).
Timepoint [6] 332344 0
Once the intervention was completed
Secondary outcome [7] 332347 0
Social risk as measured considering: Family structure, education of the primary caregiver and occupation of the primary income earner (Murray et al., 2014).
Timepoint [7] 332347 0
Baseline
Secondary outcome [8] 332348 0
Family burden as assessed with the Family burden injury interview (Burgess et al., 1999).
Timepoint [8] 332348 0
Baseline
Secondary outcome [9] 332349 0
Parent depressive symptoms as assessed with the Beck´s Depression Inventory (Beck, Steer, & Brown, 2011).
Timepoint [9] 332349 0
Baseline
Secondary outcome [10] 332350 0
Parent´s anxiety symptoms as assessed with the Inventory Anxiety State Trait (Spielberg & Diaz-Guerrero, 1975).
Timepoint [10] 332350 0
Baseline
Secondary outcome [11] 332351 0
Parent Self-regulation as assessed with the Behavior Rating Inventory of Executive Function Adult Self-report (Roth, Isquith, & Gioia, 2005),
Timepoint [11] 332351 0
Baseline
Secondary outcome [12] 332352 0
Child´s Intelectual ability assessed with the Wechsler Intelligence Scale for Children WISC-IV- (Wechsler, 2007).
Timepoint [12] 332352 0
Baseline

Eligibility
Key inclusion criteria
1) Parents must have a child aged between six and twelve years of age
(2) The child has a diagnosis of an ABI (defined as damage to the brain that occurs after birth)
(3) Child with a medical reference stating type of brain injury
(4) The injury is diagnosed at least 3 months previous to the start of the pre intervention assessment
(5) Enough medical history to determine injury level of severity (Glasgow coma scale in a medical report or neuroimaging evidence of mass lesion or neurological deficits reported by the treating medical clinician)
(6) Mothers or fathers can participate together or individually
(7) Parents must have an active and current parenting role with the child
(8) Parents must be able to comply with the study intervention and assessment protocols as is determine by the researcher during initial contact with the parent
(9) Parents must be over 18 years
(10) Parents must be able to write and read in Spanish.
Minimum age
6 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Parent with symptoms of psychosis or borderline personality (determined by a face to face interview)
(2) Child with incomplete treatment of chemotherapy
(3) Child programmed for neurosurgery
(4) Child receiving other kinds of behavior modification therapy
(5) Parent or child with history of psychiatric illness
(6) Uncontrolled seizures in the child
(7) Parent does not have current access to child

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We calculated the sample size in order to detect a difference of 0.8 SD between the two treatment arms, with a significance level of 0.05 and power of 0.80. Allowing for an estimated 20% lost to follow-up, we therefore aim to recruit a total of 66 participants, Descriptive analysis of pre-intervention child, parent and family characteristics will be conducted to explore the characteristics of families enrolled. Comparisons of continuous measures will be made using independent sample t-test or Mann-Whitney U tests (depending on the distributions of the samples). Chi squared tests will carry out between-group comparison of categorical variables.

Intervention efficacy will be assessed by comparing the outcomes of the groups at post-intervention assessment and follow-up assessment using an independent t-test or its non-parametric equivalent, depending on the distribution of the samples. Potential confounds (e.g., social risk) and moderators (e.g., child age, time since injury) will be explored. As secondary analysis linear regressions will be completed to identify predictors of intervention outcome. Both completed and intention-to-treat analyses will be conducted. The level of significance for all analyses will be 0.05.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
25/03/2016
Date of last participant enrolment
Anticipated
30/04/2017
Actual
5/05/2017
Date of last data collection
Anticipated
30/09/2017
Actual
Sample size
Target
66
Accrual to date
Final
71
Recruitment outside Australia
Country [1] 8706 0
Mexico
State/province [1] 8706 0
Mexico City

Funding & Sponsors
Funding source category [1] 295795 0
University
Name [1] 295795 0
The University of Melbourne
Country [1] 295795 0
Australia
Funding source category [2] 295817 0
Government body
Name [2] 295817 0
The National Council for Science and Technology CONACYT
Country [2] 295817 0
Mexico
Primary sponsor type
Individual
Name
Vicki Anderson
Address
Royal Children's Hospital, 50 Flemington Rd, Parkville VIC 3052, Australia
Country
Australia
Secondary sponsor category [1] 294666 0
Individual
Name [1] 294666 0
Guillermina Yanez Tellez
Address [1] 294666 0
Universidad Nacional Autonoma de Mexico, Av De Los Barrios 1, Los Reyes Iztacala, Hab Los Reyes Iztacala Barrio de los Arboles/Barrio de los Heroes, 54090 Tlalnepantla, Mexico
Country [1] 294666 0
Mexico
Secondary sponsor category [2] 294668 0
Individual
Name [2] 294668 0
Cathy Catroppa
Address [2] 294668 0
Royal Children's Hospital, 50 Flemington Rd, Parkville VIC 3052, Australia
Country [2] 294668 0
Australia
Other collaborator category [1] 279459 0
Individual
Name [1] 279459 0
Clara Luz Chavez Arana
Address [1] 279459 0
Royal Children's Hospital, 50 Flemington Rd, Parkville VIC 3052, Australia
Country [1] 279459 0
Australia
Other collaborator category [2] 279461 0
Individual
Name [2] 279461 0
Belen Prieto Corona
Address [2] 279461 0
Universidad Nacional Autonoma de Mexico, Av De Los Barrios 1, Los Reyes Iztacala, Hab Los Reyes Iztacala Barrio de los Arboles/Barrio de los Heroes, 54090 Tlalnepantla, Mexico
Country [2] 279461 0
Mexico
Other collaborator category [3] 279462 0
Individual
Name [3] 279462 0
Miguel Angel de Leon
Address [3] 279462 0
Iskalti Centre of Psychological and Educational Support , Av. Claveria No. 81, Colonia Claveria, Delegacion Azcapotzalco,Mexico, 02080
Country [3] 279462 0
Mexico
Other collaborator category [4] 279463 0
Individual
Name [4] 279463 0
Antonio Garcia
Address [4] 279463 0
Unit of High Specialty, La Raza, IMSS, Eje 1 Pte. (Calzada Vallejo), Vallejo Poniente, 07790 Ciudad de Mexico, CDMX
Country [4] 279463 0
Mexico
Other collaborator category [5] 279464 0
Individual
Name [5] 279464 0
Celia Godfrey
Address [5] 279464 0
Royal Children's Hospital, 50 Flemington Rd, Parkville VIC 3052, Australia
Country [5] 279464 0
Australia
Other collaborator category [6] 279468 0
Individual
Name [6] 279468 0
Stephen Hearps
Address [6] 279468 0
Royal Children's Hospital, 50 Flemington Rd, Parkville VIC 3052, Australia
Country [6] 279468 0
Australia
Other collaborator category [7] 279665 0
Individual
Name [7] 279665 0
Roberto Gomez Raygoza
Address [7] 279665 0
Centro Medico Nacional, Siglo XXI. Avenida Cuauhtemoc 330, Doctores, 06720 Cuauhtemoc, Ciudad de Mexico
Country [7] 279665 0
Mexico

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297091 0
The University of Melbourne Human Research Ethics Sub-Committee
Ethics committee address [1] 297091 0
Ethics committee country [1] 297091 0
Australia
Date submitted for ethics approval [1] 297091 0
28/10/2015
Approval date [1] 297091 0
18/02/2016
Ethics approval number [1] 297091 0
1545487.1

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72950 0
Prof Vicki Anderson
Address 72950 0
Royal Children's Hospital, 50 Flemington Rd, Parkville VIC 3052, Australia
Country 72950 0
Australia
Phone 72950 0
+61383416200
Fax 72950 0
Email 72950 0
[email protected]
Contact person for public queries
Name 72951 0
Clara Luz Chavez Arana
Address 72951 0
Royal Children's Hospital, 50 Flemington Rd, Parkville VIC 3052, Australia
Country 72951 0
Australia
Phone 72951 0
+525573711007
Fax 72951 0
Email 72951 0
[email protected]
Contact person for scientific queries
Name 72952 0
Cathy Catroppa
Address 72952 0
Royal Children's Hospital, 50 Flemington Rd, Parkville VIC 3052, Australia
Country 72952 0
Australia
Phone 72952 0
+61383416200
Fax 72952 0
Email 72952 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseParenting program versus telephone support for Mexican parents of children with acquired brain injury: A blind randomized controlled trial.2017https://dx.doi.org/10.1016/j.conctc.2017.06.007
N.B. These documents automatically identified may not have been verified by the study sponsor.