Parenting program versus telephone support for Mexican parents of children with acquired brain injury: a blind randomized controlled trial.

• Register: ANZCTR
• Last refreshed on: 30 September 2019
• Main ID: ACTRN12617000360314
• Date of registration: 08/03/2017
• Prospective Registration: No
• Primary sponsor: Vicki Anderson
• 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
• Date of first enrolment: 25/03/2016
• Target sample size: 66
• Recruitment status: Active, not recruiting
• URL: https://anzctr.org.au/ACTRN12617000360314.aspx
• Study type: Interventional
• Study design: Purpose: Educational / counselling / training; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Mexico

Contacts

• Name: Miss Clara Luz Chavez Arana

• Name: A/Prof Cathy Catroppa

Key inclusion & exclusion criteria

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.
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

Age minimum: 6 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Injuries and Accidents - Other injuries and accidents

Acquired brain injury;
Acquired brain injury

Mental Health - Other mental health disorders

Neurological - Other neurological disorders

Intervention(s)

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.

Primary Outcome(s)

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).[Baseline, and immediately after the intervention and three months once the intervention was concluded.]

Parent stress assessed with the Parent Stress Index short form (Abidin, 2012). [Baseline, and immediately after the intervention and three months once the intervention was concluded.]

Parenting practices assessed with the The Parenting Scale (Arnold, 1993). [Baseline, and immediately after the intervention and three months once the intervention was concluded.]

Secondary Outcome(s)

Parent depressive symptoms as assessed with the Beck´s Depression Inventory (Beck, Steer, & Brown, 2011). [Baseline]

Parent´s anxiety symptoms as assessed with the Inventory Anxiety State Trait (Spielberg & Diaz-Guerrero, 1975). [Baseline]

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).[Baseline, and immediately after the intervention and three months once the intervention was completed. ]

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). [Baseline, immediately after the intervention and three months once the intervention was completed. ]

Parent self-efficacy as assessed by the parent sense of competence scale (Menéndez, Jiménez, & Hidalgo, 2011). [Baseline, immediately after the intervention and three months once the intervention was completed. ]

Family burden as assessed with the Family burden injury interview (Burgess et al., 1999).[Baseline]

Social risk as measured considering: Family structure, education of the primary caregiver and occupation of the primary income earner (Murray et al., 2014). [Baseline]

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). [Baseline, immediately after the intervention and three months once the intervention was completed. ]

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). [Baseline, immediately after the intervention and three months once the intervention was completed. ]

Parent Self-regulation as assessed with the Behavior Rating Inventory of Executive Function Adult Self-report (Roth, Isquith, & Gioia, 2005), [Baseline]

Child´s Intelectual ability assessed with the Wechsler Intelligence Scale for Children WISC-IV- (Wechsler, 2007).[Baseline]

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). [Once the intervention was completed]

Secondary ID(s)

None

Source(s) of Monetary Support

The University of Melbourne

The National Council for Science and Technology CONACYT

Secondary Sponsor(s)

Guillermina Yanez Tellez

Cathy Catroppa

Ethics review

Status: Approved
Approval date:
Contact:

The University of Melbourne Human Research Ethics Sub-Committee