Addressing Depression and Positive Parenting Techniques (ADAPT)

NCT04298437 | Completed

• 1 other identifier: 028/2019
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

Children with emotional and behavioural difficulties (EBD) experience disproportionate social, family and academic impairment and have between two to five times increased likelihood of developing an anxiety disorder, mood disorder or other severe mental illness in adolescence and adulthood. There is a close association between parental depression and the emergence and maintenance of childhood EBD that is likely bidirectional. Parents of children with EBD experience disproportionate stress, increasing their risk for depression; yet chronic and untreated parental depression is associated with the emergence of child EBD in the first place. Therefore, designing targeted and effective assessment and treatment for parents of children with EBD that take into account parents' depression is necessary. Of pressing concern, first-line Behavioral Parent Training (BPT) treatments for parents of children with EBD are not tailored to parent's mental health needs, which may be why upwards of 40 percent of parents and children treated in these programs fail to sufficiently benefit. Existing research highlights emotional and cognitive factors that may differentiate depressed parents from non-depressed parents that may be treatment targets to improve outcomes for depressed parents and children. The main aim of the proposed project is to evaluate the feasibility and acceptability of a novel targeted treatment for depressed parents of children with EBD, along with adherence to study protocol. The investigators will use the results of the pilot study to make key modifications to study procedures and the treatment itself to increase the success of a future randomized controlled trial (RCT) to test treatment efficacy. The investigators hypothesize that:

1. 1.Recruitment will be feasible.
2. 2.The intervention will be acceptable, and there will be a high rate of adherence to study protocol.

Conditions

Oppositional Defiant Disorder; Depression; Emotional Problem; Disruptive Behavior Disorder; Attention Deficit Hyperactivity Disorder; Conduct Disorder; Behavior Problem

Keywords

Depression; Emotional and Behavioural Difficulties; Disruptive Behaviour Disorders; Oppositional Defiant Disorder; Dialectical Behaviour Therapy; Parenting Skills; Behavioural Parenting Training; Conduct Disorder; Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (3)

• Percentage of treatment sessions attended by parents measured using weekly attendance log

  Attendance Log - Clinicians leading the group sessions will track session attendance on a weekly basis along with documenting reasons for absenteeism. Treatment/recruitment will be considered feasible if greater than 70 percent of parents attend more than 70 percent of the sessions in each pilot group.

  2 years

• Treatment acceptability/satisfaction measured by weekly evaluation forms filled out by parents

  Weekly Evaluation Forms - Participants will be asked to share their opinions about session content and delivery on a weekly basis. The treatment will be considered acceptable if greater than 70 percent of all participants report adequate acceptability of the group treatment.

  2 years

• Clinician adherence to ADAPT protocol measured by fidelity checks

  Trained research staff will conduct weekly fidelity checks at the group treatment sessions to track clinician adherence to treatment content. The treatment will be considered acceptable if greater than 70 percent clinician adherence to the model is assessed by review of coded sessions checklists.

  2 years

Study Arms (2)

Parent Group Treatment

EXPERIMENTAL

Families who meet inclusion criteria will participate in the Parent Group Treatment (ADAPT Program).

Behavioral: Addressing Depression and Positive Parenting Techniques (ADAPT) Program

No Treatment

NO INTERVENTION

Families who do not meet inclusion criteria will not be invited to participate in the ADAPT Program.

Interventions

Addressing Depression and Positive Parenting Techniques (ADAPT) Program BEHAVIORAL

The intervention is a targeted parenting intervention that has modules that help parents build emotion regulation skills, distress tolerance skills and alternative and more helpful ways of thinking about the causes of their child's EBD. The program also includes behavioral parent training skills building modules.

Parent Group Treatment

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Parent is over the age of 18 years and has a child between the ages of 6 and 10;
• Parent shows clinical elevations for Depression on the Patient Health Questionnaire (PHQ);
• The child has clinically elevated Emotional Behavioural Difficulties (T-score of 65, Borderline range, 93rd percentile) on the Strength and Difficulties Questionnaire (Conduct Problem or Total Difficulties subscales);
• The parent's has capacity to tolerate a group context.

You may not qualify if:

• Parent shows active suicidal ideation, substance use disorder, or psychosis;
• Parent is not suitable for group treatment based on clinical interview;
• Parent cannot communicate in English;
• Child has a diagnosis of Autism Spectrum Disorder or Intellectual Disability (based on parent report).

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• Women's College Hospital: collaborator

Study Sites (2)

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

Centre for Addiction and Mental Health

Toronto, Ontario, M6J1H4, Canada

Location

Related Publications (10)

• Lundahl B, Risser HJ, Lovejoy MC. A meta-analysis of parent training: moderators and follow-up effects. Clin Psychol Rev. 2006 Jan;26(1):86-104. doi: 10.1016/j.cpr.2005.07.004. Epub 2005 Nov 8.

  PMID: 16280191 BACKGROUND

• Luoma I, Tamminen T, Kaukonen P, Laippala P, Puura K, Salmelin R, Almqvist F. Longitudinal study of maternal depressive symptoms and child well-being. J Am Acad Child Adolesc Psychiatry. 2001 Dec;40(12):1367-74. doi: 10.1097/00004583-200112000-00006.

  PMID: 11765281 BACKGROUND

• Ludmer JA, Salsbury D, Suarez J, Andrade BF. Accounting for the impact of parent internalizing symptoms on Parent Training benefits: The role of positive parenting. Behav Res Ther. 2017 Oct;97:252-258. doi: 10.1016/j.brat.2017.08.012. Epub 2017 Aug 23.

  PMID: 28863289 BACKGROUND

• Aitken M, Waxman JA, MacDonald K, Andrade BF. Effect of Comorbid Psychopathology and Conduct Problem Severity on Response to a Multi-component Intervention for Childhood Disruptive Behavior. Child Psychiatry Hum Dev. 2018 Dec;49(6):853-864. doi: 10.1007/s10578-018-0800-1.

  PMID: 29594940 BACKGROUND

• Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239.

  PMID: 27777223 BACKGROUND

• Eyberg, S.M., et al. Manual for the dyadic parent-child interaction coding system: Third edition. 2009, University of Florida.

  BACKGROUND

• Fanti, KA, Panaylotou G, and Fanti S. Associating parental to child psychological symptoms: Investigating a transactional model of development. Journal of Emotional and Behavioral Disorders 21(3): 193-210, 2013.

  BACKGROUND

• Peris TS, Hinshaw SP. Family dynamics and preadolescent girls with ADHD: the relationship between expressed emotion, ADHD symptomatology, and comorbid disruptive behavior. J Child Psychol Psychiatry. 2003 Nov;44(8):1177-90. doi: 10.1111/1469-7610.00199.

  PMID: 14626458 BACKGROUND

• Harvey P, Penzo JA. Parenting a child who has intense emotions: Dialectical behavior therapy skills to help your child regulate emotional outbursts & aggressive behaviors. Oakland, CA: New Harbinger Publications, 2009.

  BACKGROUND

• Perepletchikova F, Nathanson D, Axelrod SR, Merrill C, Walker A, Grossman M, Rebeta J, Scahill L, Kaufman J, Flye B, Mauer E, Walkup J. Randomized Clinical Trial of Dialectical Behavior Therapy for Preadolescent Children With Disruptive Mood Dysregulation Disorder: Feasibility and Outcomes. J Am Acad Child Adolesc Psychiatry. 2017 Oct;56(10):832-840. doi: 10.1016/j.jaac.2017.07.789. Epub 2017 Aug 10.

  PMID: 28942805 BACKGROUND

MeSH Terms

Conditions

Depression; Attention Deficit and Disruptive Behavior Disorders; Attention Deficit Disorder with Hyperactivity; Conduct Disorder; Oppositional Defiant Disorder; Mental Disorders

Interventions

Acclimatization

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Adaptation, Physiological; Physiological Phenomena; Adaptation, Biological; Biological Phenomena

Study Officials

• Brendan F Andrade, Ph.D.

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 80 parents (40 depressed; 40 non-depressed) and their children with EBD will be recruited to complete an assessment to determine objective emotional, cognitive, and behavioural markers. A subset of 20-40 depressed parents who meet inclusion criteria will be recruited for group treatment. The aim is to recruit 6-8 parents (and their co-parents) per group for each of 3 consecutive groups (target n = 36). These parents will be invited to participate in 2 individual and 8 weekly group treatment sessions. Following treatment, parents will be invited to a post-group assessment

Study Record Dates

• First Submitted: February 21, 2020
• First Posted: March 6, 2020
• Study Start: May 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 17, 2026

Record last verified: 2024-04

Locations

CA (2)